1052 - IPGT - KB - 2016 - Singh Kumari Poonam

'A RANDOMIZED CONTROLLED CLINICAL TRIAL ON
SWARNA PRASHANA AND ITS IMMUNOMODULATORY

ACTIVITY IN NEONATES’
Thesis submitted as partial fulfillment for the Degree of
AYURVEDA VACHASPATI
[Doctor of Medicine - Ayurveda]
Speciality: Kaumarbhritya
Scholar
Poonam Singh
Under the supervision of
Guide
Dr. K. S. Patel
M. D. (Ayu.), Ph.D.
Co-Guides
Dr. V. K. Kori Dr. Rajgopala S.

M. D. (Ayu.), PhD. M. D. (Ayu.), PhD.
DEPARTMENT OF KAUMARBHRITYA
INSTITUTE FOR POST GRADUATE TEACHING & RESEARCH IN AYURVEDA
GUJARAT AYURVED UNIVERSITY
JAMNAGAR - 361008 (INDIA)
June - 2016 Enrollment No. - 1654

GUJARAT ram
AYURVED
: ‘Ayu’ UNIVERSITY
Institute for Post Graduate Teaching & Research In Ayurveda
Jamnagar – 361008 (India)
Ph.- (0288) 2552014 (O), Telefax - 2676856
Email–directoripgt@ayurveduniversity.com
Website–www.ayurveduniversity.edu.in
Date. /06/2016
Certificate
This is to certify that this thesis embodies the outcome of original observations
made by Poonam Singh in the study entitled “A Randomized Controlled Clinical
Trial On Swarna Prashana And Its Immunomodulatory Activity In Neonates” in
partial fulfillment of the requirements for the Degree of „Ayurveda Vachaspati’
[M.D. (Ayu.)] in Kaumarbhritya specialty. This work has been carried out under my
direct supervision and guidance; along with co-guidance of Dr. Rajagopala S.,
Associated Prof., and Dr. V. K. Kori., Assistant Prof., Kaumarbhritya Department,
I.P.G.T. & R.A. Gujarat Ayurved University, Jamnagar.
This project has been cleared by Institutional Ethics Committee Vide Ref-
PGT/7-A/Ethics/2014-2015/1538 dated 02/09/2014. This trial is also registered in
Clinical Trial Registry of India (CTRI), ref. no. CTRI/2015/11/006337 [Registered
on: 02/11/2015].
The study embodies the outcome of original observations made by the
scholar, which makes distinct advance on scientific lines in the subject. The scholar
has put sincere and hard efforts in bringing out this thesis after making copious
contemplation of the subject by keeping the diction intact. This dissertation contains
original ideas and data, which is a definite advancement over the existing knowledge
of the subject. All the findings reported in the thesis have been checked by me time to
time.
I am fully satisfied with the research work of the scholar. I, therefore,
recommend and forward this thesis to be submitted for adjudication.
Forwarded by:
Guide:
Prof. K. S. Patel Prof. K. S. Patel

Prof. & Head, Prof. & Head,
Kaumarbhritya Department, Kaumarbhritya Department,
I.P.G.T. & R.A., G.A.U, I.P.G.T. & R.A., G.A.U,
Jamnagar. Jamnagar.
Acknowledgement
Words cannot always comprehend the deepest feelings felt by heart. Yet I
take this opportunity to express my gratitude towards all those individuals who
directly or indirectly contributed largely towards accomplishing this research work
which is indeed one of the biggest milestones of my life.
Foremost, I bow down to the feet of Lord, for blessing me and providing me
with strength to carry out my duties earnestly and for helping me out through all
the challenging times.
I am extremely happy to express my deepest sense of gratitude to my

respected guide Prof. K. S. Patel, H.O.D., Department of Kaumarbhritya, attention
upon me for completion of this work for her close and constant encouragement,
guidance, suggestions and keen attention upon me for completion of this work.
I take this opportunity to express my sincere gratitude to my co- guides Dr. V. K.
Kori and Dr. Rajagopala S. for his constant support, valuable advices and
guidance.
I convey my sincere thanks to the authorities, Vd. Rajesh Kotecha, The Vice
Chancellor of Gujarat Ayurved University Jamnagar and Dr. P. K. Prajapati,
Director, I.P.G.T&R.A., as well as and members of research committee. I am equally
thankful to Prof. K. Nishtheshwar and Dr. Galib for their valuable suggestions. I
am also thankful to Dr.Meera Cholera and Dr. V. J. Shukla for their valuable efforts
and support in this study.
I thank all the staff of Pharmaceutical, Microbiology, Pathology, Bio

chemistry laboratories and the staff of PG hospital for their cooperation during this
study.
I express my gratitude towards my seniors and friends Dr.Swapnil,
Dr.Praveen, Dr.Satyawati and Dr. Suhas, for their valuable company and timely
help. I have no words to thank my batch mate Dr. Sonam, Dr. Neha, Dr. Senani for
their great support throughout my study and also a good friend of mine. Heartfelt
thanks to my juniors Dr.poonam, Dr.Rahul, Dr. Palak, Dr.Hetal, Dr.kuldeep,
Dr.Jaidev, Dr.Monika, Dr.Renu, Dr. Bhumi, for their timely help and care. My
sincere thanks to my friends Dr.Bhavya whose company made my time memorable.
My profound gratitude to my beloved parents for whom my words fall short.

Their sacrifices, love and support have made this work highly valuable and blessed
one to me. My heartfelt gratitude to all my Brother’s and Sister who were with me
throughout the ups and downs of my life and stood beside as my strength.
I am obliged to my better half Shashi Kumar Singh, for his boundless
sacrifices, constant support, encouragement, and endless love and affection by
which he has made this great work a fruitful one.
I extend my thanks to Raju Unagar Sir, Sahajanand Computer class for give
me perfect guide about computer teaching and his valuable help during my thesis
work.
Last but not least I am indebted to all the cute little babies and their parents
who gave their time, shared their experiences and went through all the
inconveniences but agreed to be a part of this research work.
Dr. Poonam Singh

ABBREVIATIONS
A. H. Su. AshtangaHrudayaSutrasthana
A. S. Su. AshtangaSangrahaSutrasthana
AT After Treatment
BT Before treatment
Chakra. Chakrapani
Ch. Su. CharakaSamhitaSutrasthana
Ch .Vi. CharakaSamhitaVimanasthana
Ch. Sha CharakaSamhitaSharirasthana
Ch. In. CharakaSamhitaIndriyasthana
Ch. Chi. CharakaSamhitaChikitsaSthana
Ch. Si. CharakaSamhitaSiddhisthana
H.S. HaritaSamhita
K. S. KashayapaSamhita
Su. Su. SushrutaSamhitaSutrasthana
Su. Sha SushrutaSamhitaSharirsthana
Su. Chi. SushrutaSamhitaChikitsasthana
Su. Ut. SushrutaSamhitaUttartantra
T.S.P.P TarkaSamgrahaPrashastaPadabhashya
% Percentage
INDEX
Chapters Chapter Contents Page No.
Chapter 1 Introduction 01-05
Chapter 2 Conceptual Review
A. Ayurveda Review 06-32
B. Modern Review 33-65
C. Drug Review 66-87
Chapter 3 Analytical Study 88-100
Chapter 4 Clinical Study 101-127
Chapter 5 Discussion 128-167
Chapter 6 Summary and Conclusion 168-171
Bibliography i-v
Annexure
Annexure I –Informed Consent Form i – ii
Annexure II – Research Proforma --
Annexure IV – IEC --
Annexure V - CTRI --
List of Tables
SI. Particulars
No.
1. 2.1: Formulation of gold used in Jatakarma Samskara
2. 2.2: Formulation of gold in older children
3. 2.3: Antibody isotypes of mammals
4. 2.4: Routine Immunization Schedule
5. 2.5: Pharmacological properties of Swarna
6. 2.6: Chemical constituents of standard Swarna Bhasma
7. 2.7: Nutritional value of Honey per 100 gm
8. 3.1: Organoleptic characters of Trial and Adjuvant drugs
9. 3.2: Physico- chemical parameters of Trial and Adjuvant drugs
10. 3.3: Observation of Sample B1 and C1 preserved in room temperature
11. 3.4: Observation of Sample B2 and C2 preserved in refrigerator
12. 3.5: Observation of sample B3 and C3 preserved in room temperature
13. 3.6: Observation of sample B4 and C4 preserved in refrigerator
14. 4.1: Distribution of Neonates in different groups
15. 4.2 : Sex wise distribution of 58 neonates
16. 4.3: Religion wise distribution of 58 neonates
17. 4.4: Habitat wise distribution of neonates
18. 4.5: SES wise distribution of 58 neonates
19. 4.6: Maternal education wise distribution of 58 neonates
20. 4.7: Paternal education wise distribution of 58 neonates
21. 4.8: Distribution of Neonates based on Maternal Antenatal checkup
22. 4.9: Maternal H/O major illness during pregnancy wise distribution
23. 4.10: Medication consumed by the mother during antenatal period
24. 4.11: Maternal H/O Gravida wise distribution of 58 neonates
25. 4.12: H/O Maternal Parity wise distribution of 58 neonates
26. 4.13: H/O Onset of delivery wise distribution of 58 neonates
27. 4.14: Mode of delivery wise distribution of 34 neonates
28. 4.15: Complication during delivery wise distribution of 58 neonates
29. 4.16: H/O Cry after the birth wise distribution of 58 neonates
30. 4.17: Type of cry after birth wise distribution of 58 neonates
31. 4.18 :H/O Suction after birth wise distribution of 34 neonates
32. 4.19: H/O Oxygen inhalation after birth wise distribution of 58
33. 4.20: Resuscitation given after birth wise distribution of 58 neonates
34. 4.21: APGAR Score (at 1 min.) wise distribution of 58 neonates
35. 4.22: Assessment of Gestational age (New Ballard Score) wise
distribution of 58 neonates
36 4.23: Average Birth weight wise distribution of all three groups
37. 4.24: Initiation of breast feeding after birth wise distribution of 58
Neonates
38. 4.25: Colostrum fed wise distribution of 58 Neonates
39. 4.26: Exclusive Breast feeding wise distribution of 58 Neonates
40. 4.27: Presence of any Congenital anomoly wise distribution of 58
neonates
41. 4.28: H/O of Neonatal Care wise distribution of 58 neonates
42. 4.29: Effect on Anthropometric parameters- Group A (n=15)
43. 4.30: Effect on Hematological parameters- Group A (n=15)
44. 4.31 Effect on biochemical parameters- Group A (n=15)
45. 4.32: Effect on Anthropometric parameters- Group B (n= 17)
46. 4.33Table No.4.33-Effect on Hematological parameters- Group B (n=17)
47. 4.34: Effect on biochemical parameters- Group B (n=17)
48. 4.35: Effect on Anthropometric parameters- Group C (n=16)
49. 4.36: Effect on Hematological parameters- Group C (n=16)
50. 4.37: Effect on biochemical parameters- Group C (n=16)
51. 4.38: Comparative effect of Group B and Group A on
Anthropometrical parameters:
52. 4.39:Comparative effect of Group B and Group A on Hematological
parameters:
53. 4.40: Comparative effect of Group B and Group A on Biochemical
parameters
54. 4. 41: Comparative effect of group B and group A on Immunological
parameters
55. 4.42: Comparative effect of Group C and Group A on Anthropometrical
parameters
56. 4.43: Comparative effect of Group C and Group A on Hematological
parameters
57. 4.44: Comparative effect of Group C and Group A on Biochemical
parameters
58. 4.45: Comparative effect of group C and group A on Immunological
parameters
59. 4.46: Comparative effect of Group C and Group B on Anthropometrical
parameters
60. 4.47: Comparative effect of Group C and Group B on Hematological
parameters
61. 4.48: Comparative effect of Group C and Group B on Biochemical
parameters
62. 4.49: Comparative effect of Group C and Group B on immunological
Parameters
63. 4.50: Comparative effect of Group C, Group B and Group A on
Anthropometrical Parameters
Haematological Parameter
Biochemical Parameter
immunological Parameter
67. 5.1:Formulations used for Jatakarma Samskara according to
Sharngadhara, Bhavaprakasha, Yogaratnakara and Acharya Kashyapa
68. 5. 2: Reason for drop outs in all the three groups
69. 5.3: Consolidated table of effect of therapy on individual group
70. 5.4: Consolidated table of comparative effect of therapy.
71. 5.5: Consolidated table of comparative effect of therapy in all three
groups
72. 5.6:Prevalence of disorders in followup period in neonates
Introduction
INTRODUCTION
Healthy childhood is mandatory for expecting a healthy adult life and so,
childhood can be certainly named as the foundation of adulthood. Now the infectious
diseases are world’s biggest killer of children and young adults. They account for
more than 13 million deaths a year - one in two deaths in developing countries.1
Infections and infectious diseases are universally present but they are much common
in India especially among children, and take a heavy toll of their lives. If proper
precautions are taken, many of these diseases can be prevented.2
Among the full term babies, the major cause of mortality is perinatal
infections. Though National Vaccination Schedule is implicated, mortality rate in
India is still high. From the first day of life vaccination schedule is started but these
vaccines do not protect the child from the diseases caused by bacterial infections,
viral infections and primary-secondary immunodeficiency syndromes. Vaccines are
successful in preventing certain diseases like polio, measles, diphtheria etc. but they
are only a few. Vaccine takes almost 2-3 months for activation of immune system and
to produce the specific immunoglobulin’s against that specific antigen. So these are
the major lacunae that lead to increase in perinatal infections. Immunomodulators are
becoming very popular worldwide in natural health industry as people start to realize
the importance of a healthy immune system in the maintenance of health and the
prevention and recovery of diseases. An immunomodulator is a substance that helps
to regulate the immune system. This "regulation" is a normalization process, so that
an immunomodulator helps to optimize immune response. Thus immunomodulators
do not tend to boost immunity, but to normalize it.3
At this juncture a new window of research in Ayurveda opens.
Kaumarbhritya is the first hand of support offered to a new born on his arrival to this
world, to guide him towards a healthy living throughout the future. In the journey of
life from birth to the death various Samskaras are mentioned in ancient science.
Among these Samskaras, Jatakarma samskara are mentioned by different Acharyas.
Under Jatakarma samskara, Lehana is described and these Lehana given in the
Jatakarma samskara are nothing but the immunization process. The methods of
administration of Lehana told by the Acharyas are similar viz. making the
homogenous mixture of all contents and its licking to the newborn4.
A Randomized Controlled Clinical Trial On Swarna Prashana and its Immunomodulatory

Activity in Neonates Page 1
Introduction
The procedure to Swarna Prashana as Lehan, is described in Kashyapa

Samhita in much detail. It is mentioned that, keeping face towards east, gold should be
rubbed on a clean stone, then it should be mixed with Madhu and Ghrita and given to
the infants for licking. Acharya Kashyapa who is considered as the pioneer of
Ayurvedic paediatrics opines that this process of Swarna Prashana increases strength,
gives long life; is auspicious, virtuous, aphrodisiac, increases complexion and
eliminates the evil effects of grahas. Further it has been mentioned that Swarna
Prashana (administration of gold) is said to bestow babies with qualities like Medha
Agni Balavardhana with its specific Phalashruti as “vyadhibhir na cha dhrushyate”,
when given in neonate for a period of 1 month. By using for six months, child is able
to retain what-so-ever child hears (Shrutdhara).4
Various Acharyas mentioned diffrent Lehanas for the newborn mainly they are
the combination of the Ghrita, Madhu and Swarna . Acharya Charaka, mentioned
only mixture of Ghrita and Madhu5. Madhu is collected by honey bees from different
flowers, the pollen of which are antigenic in nature. Ghrita is a fatty substance which
forms a good adjuvant material with Madhu. Not only adjuvant Ghrita being a well
known fat is turned into small globulines the chylomicrons, which undergoes
absorption through the lymphatics of villi present in the inner wall of the small
intestine6.
Balyavastha (childhood) has been described in the texts of Ayurveda as a
period of minimal relative Bala (physical strength and immunity) and hence children
of this period are considered to be more prone for various diseases. A considerable
decrease in physical strength and immunity is thus said to be a causative factor of
disease.7 Vyadhikshamatva is the inherent or/and an acquired capacity of the body in
preventing occurrence of a disease or in modifying the course of an already
manifested disease to a milder extent.8 Vyadhikshamatva can be explained in
terms of protective (Vyadhibalavirodhitva) and preventive (Vyadhyutpadaka
pratibandhakatva) mechanisms of body protective system. The term
Vikaravighata bhava is also used to describe the manifestation and prevention of
diseases by Acharya Charaka,9 which can also be correlated as the state of
Vyadhikhsamatva or Bala.
By considering the above facts, it was evident that there is an urgent need to
intervene in the field of immunomodulation in children especially early infants age as

Introduction
they possess less immunity and also are exposed to variety of infectious agents daily.
Swarna Prashana is said to bestow an infant with qualities like enhanced intelligence,
metabolism, physical strength and immunity with its specific benefit as least
prevalence of diseases if administered for a period of one month. Reports of toxicity
study of Swarna bhasma had proven it to be safe for internal administration.10
Hence the present study was planned to evaluate the Immunomodulatory
activity of Swarna Prashana in neonates.
 PREVIOUS RESEARCH WORKS :

M.D. Thesis
1. M. S. Kamath (1981) , “Response of Madhu and Ghrita in New born”, I.P.G.T.
&R.A., Jamnagar
2. Amruta Gaikwad, (2011) “A Comparative Pharmaco-Clinical study of the effect of
Madhu-Ghrita and Swarna-Vacha-Madhu-Ghrita on Neonates”, I.P.G.T. &R.A.,
Jamnagar
3. Sital S Desai (2011), “Effect of Suvarnaamritaprashana in recurrent attacks of kasa”,
RGUHS, Bangalore
4. Aniket Patil (2012), “To Clinically Evaluate the effect of Suvarna binduprashan on
immunity and intelligence quotient”, BMK Ayurveda Mahavidhyalaya,KLE,
Belgaum
5. Vinamra Sharma (2012), “Toxicity study of Suvarna Binduprashana in albino rats”,
KLE, Belgaum
6. Anupriya (2013), “Safety and efficacy study of Swarna Prashana drops prepared
from Swarna Bhasma and Swarna Lavana” (Dept of RSBK), I.P.G.T.
&R.A.,Jamnagar
Ph.D. Thesis
1. Jyothy.KB, (2013), “A Randomized Controlled Clinical Trial on Swarna Prashana in

infants w.s.r. to its immunomodulatory activity”, I.P.G.T. &R.A., Jamnagar.
 Aims and Objectives:
The present study is planned with following aims and objectives:
1. To review the concept of Swarna prashana in detail.

2. To standardize Swarna prashana in neonates with respect to its dose,
safety and efficacy with special reference to immunomodulation.

Introduction
The whole study has been divided into the following chapters:
I. CONCEPTUAL STUDY: The conceptual study has been divided into two sub
groups such as review of literature and review of the drug under trial.
1. REVIEW OF LITERATURE: It consists of critical review of the literature

related to Swarnaprashana and Vyadhikshamatwa described by various texts
books of Ayurveda. The related literature from contemporary medicine, previous
research works, journals, internet etc. have also been incorporated within.
2. DRUG REVIEW: In this section details of the drugs under trial including the
Rasapanchaka, pharmacological properties, recent research findings etc. along
with the preparation in the current dosage form with standard operating procedures
have been dealt in detail.
II. ANALYTICAL STUDY: The raw drugs as well as the prepared products
were subjected to minimum standard protocol followed in the Institute for
authenticity; including microbiological studies of both the raw drugs as well as the
prepared products were carried out to assess the safety and stability with respect
to microbial contamination. The details of the above mentioned studies are
included in this section.
III.CLINICAL STUDY: This section contains the details of the clinical trial
along with the observations made in the study and effect of the drugs on various
parameters. The data generated have been systematically documented, compiled
and analysed with suitable statistical methods and presented.
IV. DISCUSSION: Important and relevant findings of the conceptual, analytical, and
clinical studies are discussed in this section of the text with supportive rationale.
V. CONCLUSION: The data and information obtained from the study are described
in this section with most suitable logical conclusions.

Introduction
REFERENCES:
1. World Health Organization Report on Infectious Diseases, “Removing Obstacles to

Healthy Development”.
2. J. Viswanathan, Avalokita B. Desai, Achar,s Textbook of Pediatrics, 3rd ed., Orient
Longman Private Limited, New Delhi, pg.no.281
3. http://www.biobran.org/comparisons/immunomodulators.html, [ last accessed
on 9/7/2015]
4. Hemaraja Sharma, Kasayapasamhita of Vrudha Jivaka, revised by
Vatsya, Sutrasthana, 18, Chaukhambha Sanskrit Sansthan, Varanasi, 2013, p.4-5.
5. Agnivesha, Charaka Samhita chakrapani Commentary, Sharir Sthana 8/46.,
edi by Yadavji Trivikramji Acharya, Varanasi: Chaukhambha Sanskrit sansthan,
reprint 2009, p.no.349
6. A.C.Guyton, John E. Hall, Textbook of medical physiology, 11th edi., Elsesvier
saunders, p.no.816.
7. Yadavji Trikamji, Charakasamhita of Agnivesha, Sharirasthana,
1/113,114, Krishnadas Academy, Varanasi, 2004, p. 298.
8. Yadavji Trikamji, Charakasamhita of Agnivesha, Sutrasthana, 28/7,
Krishnadas Academy, Varanasi, 2004, p.178.
9. Yadavji Trikamji, Charakasamhita of Agnivesha, Nidanasthana, 4/4,Krishnadas
Academy, Varanasi, 2004, p. 212.

10. Anupriya, “Safety and efficacy study of Swarnaprashana drops prepared from
Swarna bhasma and Swarna lavana”, IPGT & RA, Jamnagar, 2013.

Ayurvedic Review
AYURVEDIC REVIEW
Swarna is well known for its therapeutic importance‟s and ancient literatures of
Ayurveda described specific medicinal values of Swarna along with other herbal
medicine. The present study was postulated and conducted by following such basic
concepts of Ayurveda related to Swarna Prashana, Jatakarma Samskara, Lehana,
Vyadhikshamatwa (Immunity), Bala and Oaj, the details of which are narrated in this
chapter.
 Swarna Prashana:
Swarna Prashana (Administration of Gold ) is a unique and one of the best
example of nanomedicine applied for preventive health care in Ayurveda. It has been
traditionally practiced as a recipe for growth and enhancement of the immunity in
children. It merely indicates the metal Gold which is considered to be one among the
1
Shuddhaloha (pure metal). The word Prashana means to eat, consume or lick.2 Thus in
short the word Swarna Prashana denotes the consumption of gold by means of licking.
 Samskara:
In Hindu culture, it is believe that every aspect of life is sacred, so due to this
reason each important stage, from garbhadhana (conception) to antyeshti (death
cremation) are distinguished as special rituals. The Samskaras are performed for the
physical, social and religious development of an individual. The Upanishads mention
Samskaras as a means to grow and prosper in all four aspects of human pursuits i.e
Dharma (righteousness), Artha (wealth), Kama (work and pleasure), and Moksha
(salvation).3Acharya Charak explained the word Samskara as “Samskaarohigunaantra
dhaanam`” which means qualitative improvement carried out by incorporating the
specific qualities (transforming of the qualities).4
The number of Samskara varies in different Hindu Dharma Granthas, it is about 16 to
40. In Grihyasutra there is mentioning of 18-21 Samskaras. While in Manusrimiti, 13 of
them and in Gautama Grihya Sutra, 40 of them are explained. While the 16 Samskaras
explained by Maharshi Dayananda are widely accepted and taken into consideration by
A Randomized Controlled Clinical Trial On Swarna Prashana and Its Immunomodulatory Activity In
Neonates. Page 6
Ayurvedic Review
Ayurveda Acharyas. These 16 Samskaras are often referred to as the Shodasa

Samskaras.5 They are:-
1. Garbhadhana (Sacrament of Impregnation or Conception)
2. Pumsavana (Engendering a male issue)
3. Simantonnayana (Hair-parting)
4. Jatakarma (Birth ritual)
5. Namakarana (Naming ceremony)
6. Nishkramana (First outing or outing ceremony)
7. Annaprashana (feeding ceremony)
8. Chudakarma or Mundana (Shaving of head)
9. Karnavedhana (Piercing the earlobes)
10. Upanayana (Sacred thread initiation)
11. Vedarambha (Beginning of vedic study)
12. Samavartana (End of studentship)
13. Vivaha (Marriage Ceremony)
14. Vanaprastha (Renouncing the house holder's life)
15. Sanyasa (Leading the life of a monk)
16. Antyeshti (Death cremation)
 Jatamatra Paricharya (New born care)
Care of the Newborn immediately after birth, is a vital step because any mis-
management at this stage may prove fatal to the baby. In intra uterine life, the
phenomenon of nutrition and respiration of the fetus are conducted by placenta. Hence
newborn should immediately be stimulated for the initiation of respiration. Then the
atmospheric oxygen (Amberpiyusha) enters into the baby for its survival. While the
child is born, the amniotic membranes (Jaraayu) rupture, the phlegm in the
throat gets cleared and Vaayu enters inside. So the child starts crying 6 .Then umbilical
cord cutting, routine care (bath, cloth, dhoopan etc.) and Jatakarma samskara should be
performed according to the rituals.
Neonates. Page 7
Ayurvedic Review
 Praanpratyagaman (Immidiate care of the New born)-

a. According to the Charaka7
 Sound should be produced by the striking or rubbing of two stones
together, near the root of the ear of the newborn.
 Hot or cold water should be sprinkled on the face of the child.
Chakrapani has clarified that the hot water is used in summer while cold
in winter.
 If the child does not cry and is devoid of any movements, fanning is
suggested by winnowing baskets made up of black potsherd.
 For proper cleaning of oral cavity (including palate, lips, throat and
tongue), the attending paediatrician should use his properly cleaned finger,
whose nail has already been trimmed. Finger end must be wrapped with
cotton.
 Once the child is properly cleaned, the Brahma-randhra (Anterior
Fontanel) should be protected by putting a cotton pad, soaked in oil (Bala
taila). or removal of swallowed Garbhodaka (liquor amnii), emesis
should be induced by administering Ghrita mixed with Saindhava (rock
salt), to the newborn.
 Cutting of umbilical cord and Jatakarma samskara should be performed
according to the rituals.
b. According to the Sushruta8 -
 Sushruta has changed the sequence of processes for resuscitation and
omitted the process of stimulation of newborn by a sound produced with
the help of two stones.
 Just after birth, Ulva (vernix caseosa) should be removed from the body
and oral cavity is to be cleaned by using Saidhava lavana (rock salt) and
Ghrita.
 Murdha (Anterior Fontanel) is to be cared of by covering it with tampon
soaked in Ghrita or Bala-taila followed by cutting of umbilical cord.
Neonates. Page 8
Ayurvedic Review
 If the child is unconscious due to compression of yoni and /or by instruments

(asphyxiated) should be revived by sprinkling cold water.
 Jatakarma is performed by licking the mixture of honey, Ghrita and powder

of Ananta (gold) in the dose of one Gunja, by index finger. Bath should be given
after massaging with Bala-taila.
c. According to the Vagbhata 9
 Vagbhata has mentioned that after cleaning the Ulva (vernix caseosa), the
revival of deeply unconscious baby should be done by pouring Bala-taila on
the head and making sound by striking of two stones(details under
resuscitation of unconscious newborn).
 Cutting of umbilical cord, bath, protection of Talu, cleaning of the oral cavity
and emesis for swolled Garbhodaka have been advised as described by
Charaka and Sushruta. Astanga Hridaya has similar description to that of
Astanga Samgraha.
d. According to Other authors-

Like Chakradatta10 has followed the previous authors. Chakradatta11 has
mentioned a separate recipe for inducing emesis to remove Garbhodaka. For this
purpose powder of Sunthi, Krishna, Maricha, Pippali, Haritaki, Vacha and Haridra
mixed in breast milk should be given to newborn. During the process of resuscitation,
production of the sound by two stones may stimulate the newborn through auditory
stimulation, while sprinkling of hot/cold water may produce sensory
stimulation. The reflexes of these stimulations may ultimately stimulate the
cardio-respiratory functions.
1. Resuscitation of the unconscious or asphyxiated baby
Vagbhata12 is of opinion that if, the child is suffering from fever, deep
consciousness, decreased or unstable Dhatus, hypersensitivity of pain stimuli and the
child looks like almost dead; he should be irrigated with Bala-taila and fanning with
winnowing basket (blackened by applying smoke), should be done. Mantra should be
enchanted in the right ear of newborn 13.
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These features of asphyxiated newborn baby have quite resemblance with the
APGAR scoring used for assessing the status of the asphyxiated baby. Actually the
features mentioned by Vagbhata are different stages of hypoxia.
2. Cutting of the umbilical cord.

Charaka opines that after measuring the cord 8 angulas from the umbilicus,
it is hold with the two fingers and to be cut with the Ardha-dhrashastra. This
instrument should be made up of gold, silver, iron or any of metal. The cut end of
the cord should be tied properly with thread and hang loosely in the neck. 14
Sushruta is of opinion that umbilical cord at first should be tied at the 8
Angulas distance and then it should be cut and tied in neck of the baby. 15
Dalhana, while commenting has explained that hanging of the umbilical cord in
the neck will prevent the oozing of blood from it. The cord should be irrigated
properly with Kaustha taila.
Vagbhata has advised that umbilical cord should be cut only 4 Angula distal
to umbilicus. 16 The length of umbilical cord described by Charaka and Sushruta
seems to be much long, because it may cause inconvience to the baby but 4
Angula length described by Vagbhata is appropriate. Sushruta says that the cord
should be cut only after tieing while Charaka and other Acharyas says first to
cut then to tie. It may cause much bleeding from the cord. Tieing of the
umbilical cord in the neck protect the cord from injury, decreases the chances of
leaking the blood due to antigravity position and reduce the chance of
contamination with urine and stool.
 General care-
Bath - After delivery of the baby massage is to be done with Bala-taila. Bath
should be given, keeping the view of the Kala, vitiation or the influence of the
Doshasas and Bala of the child. Bath should be given with the luke warm
decoction of Ksiri-vriksha or luke warm Sarvagandhodaka or with luke warm
water treated with heated gold or silver rod or with luke warm decoction o f
leaves of Kapittha.17
Dalhana has mentioned the specific conditions for the use of different types of water:
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 Decoction of the Kshiri-vriksha - dominance of Pitta.
 Sarvagandhodaka – dominance of the Vata.
 Hot water prepared by immersing heated gold or silver – less strength of the
baby.
 Decoction of the Kapittha leaves - less strength of the baby
Feeding for first 4 days - Newborn after birth is totally depends on the oral feeding.
Although the mother‟s milk is best for the babies but during first few days (1-4days)
most of the mothers do not have sufficient secretion of the milk. Hence Acharyas
explained the specialized schedule for feeding. Charaka18 opines that on the first day
baby should offered honey and Ghrita as first feed and from the next feed, right breast
offered for sucking.
Sushruta19 and Vagbhata:20,21
 1st day – Madhu+Ghrita+Ananta.
 2nd day- Madhu+Ghrita+Laxmana.
 3rd day - Madhu+Ghrita+Laxmana.
 4th day – Breast milk, butter.22
Bed and cloths: Charaka has described various qualities of bed and cloths. It should
be Mrudu, Laghu, Shuchi and with fragrance. It should be devoid of sweat, micro-
organisms, urine and fecal matter. Sushruta 23 has advised that the baby should be
wrapped with soft cloths. Baby bed should have soft cloths. According to Vagbhata24
the baby should be made to sleep on a cushion made of soft cloths, keeping the head on
east side.
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 Protective measures (Raksha karma):

a. Measures advised by Charaka 25
 The twings of Adani, Khadira, Karkandhu, Pilu,Parushaka should be hanged
and Sarshapa, Atasi, Tandula and Kanaknika should be strewn around and
inside of Sutikagara.
 Tandula bali oblation should be performed in morning and evening for ten
days.
 A wooden pestle (mushala) should be placed over doorsil in oblique position.
 Various Rakshoghna drugs like Vacha, Kustha, Hingu, Sarshapa, Atasi,

Lasuna, Kakaniyaka and Guggulu etc. are kept in packet and hanged in upper
portion of the door-frame, small packets are tied on the neck of puerperal
women and newborn.
 Two earthen pots filled with the water are kept at sides of bed and both the
pannets of door. Inside the Sutikagara fire should be lit daily with the woods of
Kanakakantaka or Tinduka.
 The attendants present in Sutikagara remain awake for 10-12 days to take the
special care of the mother and newborn. Shanti-homa should be performed daily
in the morning and evening.
b. Measures advised by Sushruta26
 Baby should be fanned with twigs of Pilu, Badri, Nimba and Parushaka.
 Tampon soaked in oil should be applied over head.
 Fumigation with the Rakshoghna Dravyas should be done and the small
packets of it tied on the arms, legs, head and neck of the newborn.
 Tila, Atasi, Sarshapa and Pippali should be scattered all around.
 Measures prescribed for the wounded person may be taken into consideration.
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c. Measures advised by Vagbhata27
 The fanning by the twigs of various drugs like Adari, Vidari, Khadira, Nimba,
Pilu and Parushaka should be done on baby. These drugs should be scattered
in Sutikagara, inside and outside the house.
 Dhupana should be done by Guggulu, Agru, Sarjaras and Gaura Sarshapa.
 Shanti Karma should be done for 10 days. For this purpose recitation of the
Mayuri, Mahamayuri, Arya,Ratnaketu, Dhrini should be done twice a day. Small
packets containing Hingu, Vacha and Turushaka should be tied in the head and
neck of the baby. Bhurja-patra having inscription of hymn like Parnasbri,
Arya, Aparajita written with Gorochana, should be tied in the head and neck of
the child.
 Concept of Jatakarma Samskara
This is the first and the foremost Samskara done to the child after birth. The
word Jatakarma Samskara is composed of two words; Jatakarma and
Samskara. It possesses Socio-cultural and medical importance. The word
Jatakarma specifies the procedures carried out in basic new born baby care at
or from the time of birth. It is said to be one among the 10 Samskara
mentioned by Acharya Bhavadeva Bhatta28 and Acharya Harita.29 Acharya
Charaka mentions Jatakarma as a separate procedure itself wherein a mixture of
only ghee and honey should be first administered in a baby by chanting
spiritual hymns followed by initiation of breast feeding.30 Acharya Chakrapani
further clarifies that this is a procedure performed in a new born baby as told in
31 32
Vedic literature. But Acharya Sushruta and Vagbhata have mentioned the
administration of gold along with other herbs in this context. Acharya Vagbhata
uses the words Lehana and Prashana in this context. Glimpses of
administration of gold in newborn baby are also found in the texts Rasaratna
Samuchchaya 33 and Kalyanakarakam34 which are very similar to the above
cited references.
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 Administration of Swarna (gold) according to different Acharyas:

Acharya Sushruta further explains the administration of gold along with other
herbs for a period of 1 year31. Acharya Dalhana explains in the commentary that
there is an opinion of administration of these drugs till the age of 12 years. The
term ‘Kumara’ is used in this context and so, it can be considered that gold is
indicated in a child of the age group in whom development of reproductive
system is not yet complete.35 The word Kumara is also used in the
37
references of Bhavaprakasha36 and Yogaratnakara. The formulation of gold
is mentioned as Pushtikara Yoga (Nutritious formulation) in Bhavaprakasha.
In all the references, it is said that gold should be administered along with
honey and ghee as Anupana. The compiled references are listed in the table given
below.
Table 2.1: Formulations of gold used in Jatakarma Samskara and later-
Sl.no. Reference Formulation Dose Indication

31
1. Sushruta Swarna Churna At birth
Samhita (Powder of Gold) 1 Gunja 3 times on 1st
31
day
2. Ashtanga Aindri, Brahmi, At

Hrudaya Vacha, 1 Harenu Birth32(Single
Shankhapushpi, dose)
Haritaki,
Swarna Churna
& Amalaki
Swarna
Churna, 1 Harenu Till 1 year32
Shweta Vacha,
Kushtha,
Arkapushpi,
Matsyakshaka,
Kaidarya, Vacha
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3. Sharngadhara Swarna Not At birth (Single

Samhita mentioned dose)38
4. Rasaratna Kana (Pippali) & 1/4thRatti At birth
samuchchya Swarna (Singledose)39
chaya
5. Kalyanakarakam Swarna Alpamatra Acc.to age of
Bhasma, Vacha, acc.to agni infants40
butter/ghee
6. Bhaishajya Swarna Bhasma, 1/32 Ratti Till1 year41
Ratnavali Kustha,
Vacha, Haritaki &
Brahmi
Table 2.2 : Formulations of gold in older children
Sl.no. Reference Formulation Dose Indication
1. Sushruta Swarna, Brahmi & According In Kumara 31

Samhita Shankhapushpi to age
Swarna, Arkapushpi,Vacha
churna
Swarna, kaidarya, Shweta
durva
2. Bhava Swarna churna, Kustha, Not In Kumara36

Prakasha Vacha mentioned
Swarna, Brahmi &
Shankhapushpi Churna
Swarna , Arkapushpi & Vacha
Churna
Swarna, Kaidarya & Shweta
Durva
& Shankhapushpi
Churna
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3. Yoga Swarna Churna, Kustha, Not In Kumara37

Ratnakara Vacha Mentioned
Swarna, Brahmi &
Shankhapushpi churna
Swarna, Arkapushpi & Vacha
Churna

Importance of Jatakarma Samskara:
1. Medha Janana (promotion of intellect) - It is the main object of this Samskara. For
this purpose the father with his fore-fingers and instrument of gold, gives honey and
Ghrita or Ghrita alone to the child. Charaka described, Ghrita is a beneficial substance
for memory, intellect and talent. The properties of honey and gold are equally favourable
to the mental progress of the child. Honey and Ghrita are rich source of carbohydrate
and fat, respectively. These may provide energy to the child, even used in small
quantity.
2. Ayushya (for longevity) - It may be the purpose of this Samskara. It is for

ensuring a long healthy and happy life for the child. The father does chanting of
Mantras near right ear of newborn, Agni is long lived; through the herbs etc. The
Brahmana is long lived, through Amratatva, etc. The Rishis are long lived through
observance, etc.; Sacrifice is long lived through sacrificial fire, etc.; the ocean is long
lived through the rivers, etc. Another method is also described for prolonging the life of
the child. Father should invite five Brahmans. They should sit towards five regions and
should breathe upon the child. One in the south with “back-breathing”; one to the west
“down- breathing”; one to the north, “out-breathing”. The breathing was through to be
productive of life, therefore, this ceremony was performed to strengthen the breath of
the child and prolong the life of the child.
Strength- Next purpose of Jatakarma Samskara is to provide strength to the new
born. The father performs this rite. He asks the new born, “Be a stone, be an ox”, be an
imperishable gold. Though indeed the art of the self called son; thus live a hundred
autumns. In this Samskara during the process of giving honey and Ghrita to the new
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born, the attending physician may observe for rooting, sucking and swallowing reflexes
of newborn. Rooting reflex appears at birth and normally disappears at the age of 9
months. 18 It enables him to find the breast or finger having honey and Ghrita, without
being directed to it. Its absence since birth to 9 months indicates bulbar palsy and
hypotonia. Similarly sucking reflex is present since birth and disappears by 4 th
42
month (awake) and 7th month (asleep) . Its absence in the stipulated period indicates
that newborn is depressed, sick or premature. If these reflexes are absent and the feed is
given forcefully then it may cause aspiration of food material which may prove fatal.
Rakshoghna- Rakshasas (evil demons) can be understood as micro
organisms. The drugs capable of killing the same may have been called as Rakshoghna
dravyas which may act as absorbents and disinfectants. The insect referred above
may be carrying the Tetanus infection from cow-dung. Probably the insects get
attracted by the neonatal smell, hence deep caution is warned. The overall target of 12
days might be aimed at preventing neonatal sepsis more susceptible in these days. The
formalities much described on the name of customs and traditions may be to alert the
attendance to watch for neonatal complications like fever, seizures, apnoea, cord
bleeding etc. later the child slowly gets adjusted to the environment.
Concept of Lehana:
The description of Lehana in detail has been given in Leha Adhyaya of
Kashyap Samhita one of the ancient book of Kaumarbhritya . Nature of food is grossly
divided into Pana, Ashana, Bhakshya, Lehya. This denotes the process of food being
sent in GIT. Lehya means a substance meant for Lehana (process of licking by tongue).
Lehya are usually unctuous, sticky semisolids, a variety of medicinal preparation. In
children, it is a convenient and safer way of medicinal administration. The purpose and
object of Lehanakarma look to prevent the diseases by establishing due immunity and
to promote the physical and psychic strength. The Sukham and Duhkham i.e. health and
disease stage are dependent on Lehanaprakriya 43
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44
Indication of Lehanakarma in children-
 Mother‟s or Dhatri’s breast milk is absent or reduced in quantity or vitiated.
 Mother undergoes difficult labour.
 Mother suffers from acute disease.
 The child suffers from the diseases of Vata and Pitta without the involvement of
Kapha.
 Child‟s dissatisfaction even after receiving milk.
 Excessive cry of child.
 Sleeplessness at night
 When the child has good digestive capacity.
 Emaciation of the body though not suffering from any diseases.
 Reduced quantity of stools and urine inspite of excessive intake of food.
According to Acharya Kashyapa,45 Lehana preparations serves the dual purposes they
fulfil the nutritional requirement of the body as well as they are used as supplementary
foods. The children who either cannot get sufficient breast milk due to various
reasons or are not able to receive required calories, though having the good digestive
power, thus, suffer from the ematiation etc. have only been advised these lehana.
45
Contraindication for Lehana
 Mild digestive capacity.
 Excessive sleep.
 Polyuria.
 Diarrhoea.
 Too delicate and too rigid bodily constitution.
 Whose mother is died.
 Indigestion.
 Excessive intake of breast milk.
 Jaundice.
 Oedema.
 Anaemia.
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 Hridroga.
 Dyspnoea.
 Cough.
 Diseases of anus, bladder and abdomen.
 Flatulence.
 Ganda.
 Visarpa.
 Severe vomiting.
 Tastelessness.
 All graharogas.
 Alasaka.
 In bad days under influence of excessive atmospheric wind.
In the described conditions, the Lehays made of drugs unsuitable to the

individuals, and in excessive doses are contraindicated.
Contraindications of the Lehana seem to be mainly for Kaphaja disorders,
though the certain other conditions have also been mentioned. It is established fact
that the any diet other than the mother‟s milk requires better digestive power. The
children whose digestive power is influenced due to some reason or who suffering
from the jaundice, edema etc. need very special dietetic regimen and cannot be given
general supplementary food. Amongst the various contraindication of the Lehana, the
Ama dosha and Alasaka are also one. Ama dosha refers to the metabolites produced due
to indigestion (mild to severe), while Alasaka seems to be the description of stasis of
food or its sluggish movement with or without any severe complications according to
48
Charaka46 and Vagbhatas47, and the paralytic ileus or intestinal obstructions as per
the description of Sushruta 49; in these condition also routine supplementary food
cannot be given.
Importance of the Lehana-

Several materials for Lehana enlisted in the Adhyaya reveal all the varieties of
drugs, viz. Medhya, Balya, Dipana, Pachana etc. Kashyapa mentioned all of the
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materials with reference to children only whereas the other classics described them in
general. Many of the materials to be given to the neonate only. There the purpose and
the object are to induce immunity besides other aspect like longevity, intelligence,
complexion etc.
Some other Lehya indicated to the infants during weaning might be aimed at
extending as food of supplemental value whereas some other Ghrita or powders
advocated during Bala Vikasa might be to support growth and development by
augmenting anabolism and some others are directly advised in certain diseases.50
Formulations described for the purpose of Lehana are-

-Swarna Prashana
-KalKyanaka Ghrita
-Panchagavya Ghrita
- Brahmi Ghrita
-Abhaya Ghrita
-Samvardhana Ghrita
Certain herbal drugs are also mentioned in the same context which is
to be administered along with ghee and honey. In brief all the Lehana
formulations are cited to be beneficial in increasing metabolism, intellectual capacity,
physical strength and immunity.
Swarna Prashana is the first formulation explained by Acharya Kashyapa in
the context of Lehana.
Vighrushyadhautedhrushatiprangmukhilaghunambuna I
Aamathyamadhusarpirbhyamlehayetkanakamshishum II
Suvarnaprashanamhyetanmedhagnibalavardhanam I
AayushyammangalampunyamvrushyamvarnyamgrahapahamII
Masatparamamedhavivyadhibhirna cha drushyate I
Shadbhirmasai: shrutadhara: suvarnaprashanatbhavet II Ka. Su.18
This unique formula has been explained wherein gold should be triturated along with
water; honey and ghee on a pre-washed and clean stone facing eastern direction and
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made the Shishu (infant) lick the same. The specific benefits ascribed to Swarna
Prashana are as follows.
1. Medha Agni Bala Vardhanam (Improvement of intellect,

digestion, metabolism, immunity and physical strength)
2. Ayushyam (promoting life span)
3. Mangalam (auspicious)
4. Punyam (righteous)
5. Vrushyam (aphrodisiac)
6. Varnyam (enhancement of colour and complexion)
7. Grahapaham (protection from all evil spirits including microorganisms)
The specific benefits of Swarna Prashana according to the duration of administration

has also been mentioned as,
 If administered for 1 month, the baby will become Parama Medhavi (highly
intelligent) and Vyadhibhir Na Cha Drushyate (will not be affected by any
diseases)
 If administered for 6 months, the baby will become Srutadhara (will be able to
remember the things which are just hear )
All the above said benefits indicate the enhancement of all favourable factors required for
proper growth and development of a child, which is considered to be rapid during
Shaishava Avastha (Infancy).
Concept of Vyadhikshamatva:
The word „Vyadhikshamatva‟51 is explained by Acharya Chakrapani as,
“Vyadhikshamatvam nama vyadhibala virodhitwam
Vyadhyutpadaka pratibandhakatwamiti”52
The term Vyadhi is a synonym of disease and Kshamatva indicates the resistance or
tolerance of the body to fight against the diseases.Thus it is the competency of an
individual to prevent the onset of a disease or to resist the severity of an already
manifested disease. While describing Jwara Chikitsa, Acharya Charaka describes that
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health of an individual is dependent upon Bala.28Acharya Sushruta while explaining

Ojas as Bala says that, in whom Bala has been extremely reduced becomes difficult to
treat.53So it can be said that Vyadhikshamatwa mainly depends on Bala of the
individual. Bala forms in the body through three main sources; Sahaja, Kalaja and
Yuktikrita.54
1. Sahaja Bala (Natural constitutional strength):

Sahaja Bala is the natural resistance of the body and mind (Sahajam Yat Sharira
Satvayo Prakrutam).It is that which is acquired from the formation of embryo
onwards. Thus the quality of Shukra, Artava, Kala and Garbhashaya influences it
considerably which in turn are dependent upon the factors enlisted below:
 Place of birth
 Time of birth
 Genetic factors
 Physical health (compactness and strength of the muscle)
 muscles)
Predestined by deeds of previous life
 Compatibility to all kind of food.
2. Kalaja Bala (Temporal Strength)

Kalaja Bala is that which is gained from the favourable conditions of time and
season. (Kalakrutam Rutuvibhagajam Vayakrutam)
 Favourable season – In Hemanta and Shishira Ritu, Bala is said
to be maximum.
 Favourable age – Bala will be more in Youvana (youth).
3. Yuktikruta Bala (Acquired strength):

Yuktikruta Bala is that which is adapted by the wholesome practice of diet,
lifestyle and suitable medications (Ahara Cheshta Yogajam).
 Food - Balanced and nourishing food substances like ghee, meat etc.
 Lifestyle- Proper rest, exercise etc.
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 Formulation - Consumption of Rasayana drugs
Acharya Charaka explains that Bala is due to the normalcy of Kapha in the body as
stated as,
Prakrutastu Balam Sleshma Vikruto Mala Uchyate55
The verse continues as this normalcy of Kapha is only the reason for formation of
Ojas in the body. One among the normal functions of the Kapha is Kshamatva56 which
can be interpreted as tolerance. As the normalcy of Kapha contributes to the status of
Ojas and Bala of an individual, this normal function of Kapha can be inferred as
the tolerance of the body against manifestation of a disease. Thus childhood
period, which is considered as Kapha Dosha dominant phase of age, the tolerance
against diseases, should also be more compared to other age groups. But relative
Bala of an individual will always be minimal during the periods of Rutusandhi, Adana
Kala, Balyavastha and Vriddhavastha. A considerable decrease in physical strength
and immunity thus said to be a causative factor of disease57. Hence, childhood
becomes the period which is more prone for the ailments. This may be due to the fact
that children are said to be having some limitations in the body systems such as-
 Aparipakwa Dhatum- Immaturity of body systems

 Ajata Vyanjanam- Underdeveloped organs
 Sukumaram - Tenderness of the body & mind
 Aklesha Saham- Inability to withstand difficulties
 Asampurna Balam- Incomplete development of bodilystrength and immunity
58
 Sleshma Dhatuprayam - Predominant Kapha Dosha
Among these, the immaturity of Dhatu, incomplete development of bodily strength and
immunity very well clarifies the status of Ojas in the body of a child. Another term which
is used to describe manifestation and prevention of diseases by Acharya Charaka is
Vikara Vighata Bhava59 which can also be correlated as the state of Vydhikshamatva or
Bala.
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The Concept of Ojas and Bala:

The meaning of the term Ojas can be interpreted from its roots which carry the
similar meaning as that of Bala. One of this means, to bestow power and vitality and
the other means to keep the bodily tissues and organs in their optimum functional
state. It implies that the Ojas is responsible for the maintenance of the homeostasis in the
body and thus prevent manifestation of any disease.
60
Acharya Chakrapani described that Ojas is of two types :
 Para Ojas: Ashta Bindu Pramana [eight drops] located in the Hridaya.
 Apara Ojas: Ardhanjali [1/2 handful] distributed throughout the body.
Physical characteristis of Ojas:
„Jala’ is the predominant Mahabhuta in Ojas because of which it is called as Somatmaka

i.e. fluid in nature, by virtue of which it flows through the capillaries all over the
body61 . It is slightly reddish yellow and identical to ghee in colour62.
According to Kashyapa it is Shyava i.e. dark brown in colour63 . It has sweet taste like
milk and smell similar to Laja.64 (parched rice). The qualities of Ojas are described as
Snigdha (unctuous), Sara (mobile), Mritsna (slimy), Shlakshna (smooth), Picchila
(sticky), Sthira (which makes the body parts firm), Mridu (soft), Guru (heavy) and
Sheeta Virya (cold in potency). 40 It is said to be the best Pranayatana (in which life is
dependent upon).65
Thus it is evident that Vyadhikshamatva depends on Bala, which in turn is dependent

upon status of Ojas. Ojas has the qualities similar to Kapha and Prakrita Kapha is
said to be Bala which is synonymous with Ojas.
Thus Ojas, which is named as the „Rasadi Dhatu Sara‟ (the essence of 7 Dhatu) by
Acharya Susruta remains to be the factor which supports the body from weakening
because of diseases. Thus the terms Vyadhikshamatva, Vikara Vighata Bhava, Bala and
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Ojas can be used as synonyms dealing with the different aspects of immunity in an
individual.
Balavriddhikara Bhava (factors responsible for promotion of strength):

The following are the factors responsible for promotion of strength66-
 Balavat Purushe Deshe Janma (birth in a country where people are
naturally strong)
 Balavat Kale Janma (Birth in the period of time when people naturally
gain strength)
 Sukhashcha Kalayoga (pleasant and moderate climate)
 Bijaguna Sampat (excellence of the qualities of sperm and ovum)
 Kshetraguna Sampat (excellence of the qualities of female
reproductive system)
 Ahara Sampat (excellence of ingested food)
 Sharira Sampat (excellence of the physique)
 Satmya Sampat (wholesomeness of various factors responsible for health)
 Satva Sampat (excellence of the metal faculty)
 Swabhava Samsiddhi (favourable deposition of the nature)
 Yauvanam (youth)
Concept of improving Bala (Immunization measures and measures to increase

natural resistance)-
1. Jatakarma Samskara (Immunization measure)-
The Samskara means to bring transformation in quality, the description of
Shodhasha Samskara is aimed at celebrating the functional achievements of a child.
The Samskara are also aimed at sanctifying, impressing, refining and perfecting an
individual particularly in his childhood period.
The uses of Samskara are many :
 The performance of the Samskara is a means of self-expression through which
a man can express his joy, felicitations and sorrows at different stages of life.
 Secondly it is useful in cultivating culture in an individual.
Neonates. Page 25
Ayurvedic Review
 Thirdly it gives the human being ample of scope to express love for every art in
this nature.
 Fourthly it also has a social impact because it not only brings the family together
but also the friends, well-wishers and the community around.
 Lastly Samskara also help in bringing spiritual development in an individual.
The descriptions of Shodasha Samskara include all the period of life beginning
from conception to death. Even though the sustained efforts of cultivation and
refinement beginning from conception will bring fruitful results in an individual but
much concentration should be given to the period immediately after birth, when he is
exposed to a hostile atmosphere from a previous protected environment.
Keeping in view of the above idea, all the authors of Samhita Grantha advised
Jatakarma Samskara to be carried out immediately after birth as a part of
Navajatashishu Paricharya67. In this,they advised to give Madhu Ghrita mixed with
various brain tonics for the kid. The pollen of honey is a known antigen as the source
is the flower of different Rasa, Guna and Prabhava. The mixture of ghee may be
sustaining the said property of honey after entering the system without being
immediately metabolized by the liver as the fats bypass the liver so as to reach the
systemic circulation. Also the mixture might have different antigenic components and
induces the antibody production in the body.
2. Measures to increase the natural resistance-
These are nothing but the measures of representative the Ojus. Rasayana chikitsa
and Vajikarana chikitsa are together called as Urjaskara chikitasa i.e. these two
therapies are to promote Ojus. By these therapies all the 7 Dhatus get properly
nourished and stabilized, and in turn Ojovriddhi takes place.
A. Rasayna Chikitsa-
The word Rasayana is made up of two Sanskrit words, rasa (nutrition) and Ayana
(transportation in the body). Thus, Rasayana refers to single or compound preparations
containing multiple herbs and minerals that improve transportation of nutritional
materials to body tissues68 . The fundamental underlying theme of Rasayana is
Neonates. Page 26
Ayurvedic Review
nutrition. They are part of the overall balanced diet. Rasayana are claimed to
improve vitality, rejuvenate body tissues, improve immunity, and prevent aging.
Rasayana may act in a variety of ways by improving the nutritional value of the
food, digestion and absorption of nutrients, transportation of nutrients to tissues,
bioavailability of nutrients, metabolism of nutrients in tissues, immunity, and by
cleaning the Srotas (microcirculatory channels or pores) which improve uptake of
micronutrients.
Basically, Rasayana are classified into three categories 69-
 Ajasrika Rasayana (nutrition, dietary) is taken regularly with food as nutrition.
 Kamya Rasayana (normal health promoter) is indicated to improve vigour,
vitality, and to make a healthy person feel better.
Kamya Rasayana is further classified into three categories:
- Pranakamya Rasayana (promoter of life vitality and longevity);
- Medhakamya Rasayana (promoter of intellect);
- Srikamya Rasayana (promoter of skin complexion and lustre).
 Naimittika Rasayana is indicated to promote vitality in particular disease.
Ayurvedic physicians should be consulted to determine the appropriate
Rasayana required depending upon the health needs.
Rasayana are the Ayurvedic equivalent to modern dietary supplements.
It is understandable that vitamins, minerals, and biologically active steroids,
alkaloids, glycosides, tannins, and a variety of antioxidants present in Rasayana
would be a good source in providing necessary nutrients to the body.
Sometimes an overdose of pure vitamins in modern dietary supplements can
cause serious side effects. There is virtually no possibility of an overdose of
any specific vitamin or mineral from a Rasayana.
B. Vajikarana Chikitsa:
Vajikarana means the process of improving “Shukra” in an individual of its
depletion. Shukra can be classified as Antah and Bahya shukra. The antah
shukra is responsible for Bala, Varna, Upachaya etc. anabolic actions in both
the sexes. The Bahya shukra is responsible for development of secondary
Neonates. Page 27
Ayurvedic Review
sexual characters, growth of genital organs and for the process of oogenesis
in female and for the process of spermatogenesis in male. This classification
reveal that one variety of the Shukra is present in both sexes and is to seat in
the entire body with the functions of Bala, Varna and Upachaya (strength,
complexion and growth), the anabolic action of which induces the
multiplication of cells too. The anothervariety of Shukra- Bahaya shukra is
responsible for reproduction. So, it is clear that the Vajikarana therapy may
aim that one of the above two or both. But the popular view is that this
Vajikarana therapy is only to promote sexual potentialities. It is absolutely
partial and incomplete understanding.
In the Vajikarana adhyaya Charaka firstly mentioned that the marriage
should be done in Atulyagotra i.e. consangious marriages should be avoided70.
Now the fact is established that the consangious marriages are major cause of
the chromosomal anomalies found in the child. The promotion of the Shukra is
to be the promotion of the Ojus which sustains the immunity of the body. Such
Vajikara drugs are Guru, Madhur, Snigdha, Jivana, Brihana properties71.
These are the Ojovardhak drugs which ultimately increases the Ojus acts as
immunomodulatory action.
In children, procedures like Lehana, Jatakarma Samskara and
Rasayanchikitsa can be followed to protect Bala. Although there are measures
to improve Bala it is highlighted by Acharya Charaka that all the
individuals do not possess the same strength to be protected from diseases. 72
Neonates. Page 28
Ayurvedic Review
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Neonates. Page 32
Conceptual study
MODERN REVIEW
IMMUNOLOGY- The branch of science that deals with the responses of the body when
challenged by antigens is called immunology1.In a world filled with pathogens and microbes,
good health and resistance to disease is not an accident. It requires a vigorous, vigilant
immune system to keep the body free from pathogens2.
IMMUNITY: 
The human body has the ability to resist almost all types of organisms or toxins like bacteria,
viruses and foreign tissues, that tend to damage the tissues or organs. This capability is called
3
immunity. 
There are three levels of defence mechanism for protection against pathogens:
1. The first line of defence mechanism (non-specific) is the physical barrier (skin and
mucous membrane).
2. If the pathogen breaches these barriers, the innate immune system provides an immediate,
but non-specific response.
3. However, if pathogens successfully evade the innate response, vertebrates possess a third
layer of protection, the adaptive immune system, which is activated immune system,
which is activated by the innate response. Here, the immune system adapts its recognition
of the pathogen. This improved response is then retained after the pathogen has been
eliminated, in the form of an immunological memory, and allows the adaptive immune
system to mount faster and stronger attacks each time the same pathogen is encountered.
First line of defence: skin and mucous membranes-

The skin and mucous membranes of the body are the first line of defence against pathogens4.
These structures provide both physical and chemical barriers that discourage pathogens and
foreign substances from penetrating the body and causing disease.
The outer epithelial layer of the skin-the epidermis-provides a formidable physical barrier to
the entrance of microbes. In addition, periodic shedding of epithelial cells helps remove
microbes at the skin surface. Bacteria rarely penetrate the intact surface of healthy epidermis.
If this surface is broken by cuts, burns, or punctures, however, pathogens can penetrate the
epidermis and invade adjacent tissues or circulate in the blood to other parts of the body.
The epithelial layer of mucous membranes, which line body cavities, secretes fluid called
mucus that lubricates and moistens the cavity surface. Because mucus is slightly viscous, it
traps many microbes and foreign substances. The mucous membrane of the nose has mucus-
A RANDOMIZED CONTROLLED CLINICAL TRIAL ON SWARNA PRASHANA AND ITS

IMMUNOMODULATORY ACTIVITY IN NEONATES Page 33
Conceptual study
coated hairs that trap and filter microbes, dust, and pollutants from inhaled air. The mucous
membrane of the respiratory tract contains cilia, microscopic hairline projections on the
surface of the epithelial cells. The waving action of cilia propels inhaled dust and microbes
that have become trapped in mucus and its entrapped pathogens out of the body. Swallowing
mucus sends pathogens to the stomach where gastric juice destroys them. Other fluids
produced by various organs also help protect epithelial surfaces of the skin and mucous
membranes. The lacrimal apparatus of the eyes manufactures and drains away tears in
response to irritants. Blinking spreads tears over the surface of the eyeball, and the continual
washing action of tears helps to dilute microbes and keep them from settling on the surface of
the eye. Tears also contain lysozyme, an enzyme capable of breaking down the cell walls of
certain bacteria. Besides tears, Microbial invasion is countered by two types of responses i.e.
innate (non specific) and acquired (specific).
Innate immunity:
An additional portion of immunity results from general processes, rather than from processes
directed at specific disease organisms. This is called innate immunityiii. It includes the
following-
1. Phagocytosis of the bacteria and other invaders by white blood cells and cells of the
tissue macrophage system.
2. Presence of certain chemical components in the blood that attach to foreign organisms
or the toxins and destroy them. Some of these components are -
 Lysozymes -A mucolytic polysaccharide that attacks bacteria and causes them to

dissolve. 
 Basic polypeptides- Which react with and inactivate certain types of gram-positive
bacteria. 

 The complement complex- A system of about 20 proteins that can be activated in
various ways to destroy the bacteria. 
 Natural killer lymphocytes-That can recognize and destroy foreign cells, tumor cells
and even some infected cells. 
The innate immune system makes the human body resistant to such disease as some
paralytic viral infections of animals, hog cholera, cattle plague and distemper- a viral
disease that kills the large perchantage of the dogs that becomes afflicted with it.
Acquired immunity:
In addition to its innate immunity, the human body has the ability to develop

Conceptual study
extremely powerful specific immunity against the individual invading agent such as
lethal bacteria, viruses, toxins and even foreign tissues from other animals. This called
acquired immunity3. Acquired immunity is caused by special immune system that
forms antibodies and/or activated lymphocytes that attack and destroy the specific
invading organisms or toxins. It is with this acquired immune mechanism and some of
its associated reactions-specially the allergies.3
Two properties distinguish immunity from non-specific defences-
 Specificity for particular foreign molecules (antigens), which also involves

distinguishing self from non self molecules. 

 Memory for most previously encountered antigens so that a second encounter 
Prompts an even more rapid and vigorous response.
Antigens and antigen receptor-
Both the types of acquired immunity are initiated by antigens. Because acquired
immunity does not develop until and after invasion by the foreign organism or toxin,
hence the body must have some mechanism for recognizing this invasion. Each toxin
or each type of organism almost always contains one or more specific chemical
compounds. These are proteins or large polysaccharides, called as antigens. For a
substance to be antigenic, it usually must have the higher molecular weight, 8000 or
greater.i
Antigens have two important characteristics-
 Immunogenicity - It is an ability to provoke an immune response by stimulating the
production of specific antibodies, the proliferation of specific T cells or both.
 Reactivity- it is the ability of the antigen to react specifically with antibodies or cells
it provoked. 
Substance with both immunogenicity and reactivity are considered complete antigen.
Entire microbes or parts of microbes may act as antigens. Chemical components of the
bacterial structures such as flagella, capsules and cell wall are antigenic, as are bacterial
toxins. Non microbial examples of antigens include chemical components of pollen, egg
white, incompatible blood cells and transplanted tissues and organs. The huge variety of
antigens in the environment provides myriad opportunities for provoking the immune
response. Just certain small part of the large antigen molecule act as a trigger for the
tissue responses. These small parts are called as epitopes. Most antigens have many
epitopes, each of which induces the production of a specific antibody or activates specific
T cell.

Conceptual study
Antigens that get past the nonspecific defences generally follow one of three routes
into lymphatic tissue-
i. Most antigens that enters the blood stream (for e.g. through an injured blood vessels)
get trapped when flow through the spleen.
ii. Antigens that penetrate the skin enter lymphatic vessels and lodge in lymph nodes.
iii. Antigens that penetrate mucous membrane are entrapped by mucosa associated
lymphatic tissue.
Chemical nature of the antigens-

Antigens are large complex molecules, most of the more proteins. However, nucleic acid,
lipoproteins, glycoproteins, and certain large polysaccharides may also act as antigens. T
cells respond only to antigens made up of proteins. B cells respond to antigens made up of
proteins, carbohydrates and nucleic acids. Complete antigens usually have large molecular
weights of 10,000 Daltons or more, but large molecules that have simple repeating subunits
are not usually antigenic. This is why plastic materials can be used in the artificial valves or
joints. As a rule, antigens are foreign substances; they are not usually the part of the body
tissues. However, sometimes the immune system fails to distinguish friend (self) from foe
(nonself). The result in an autoimmune disorder in which self molecules or cells are attacked
as they were foreign3.
Immune system:
The immune system recognizes microorganisms and other foreign materials, discriminates it
from self and mounts an appropriate response to eliminate it.5 1(opghai) The human immune
system has evolved over millions of years from both invertebrate and vertebrate organisms to
develop sophisticated defense mechanisms to protect the host from microbes and their
virulence factors. Immune system is a collection of mechanisms within an organism that
protects against disease by identifying and killing pathogens and tumor cells. It detects a
wide variety of agents, from viruses to parasitic worms, and needs to distinguish them from
the organism‘s own healthy cells and tissues in order to function optimally.
The normal immune system has three key properties: a highly diverse repertoire of antigen
receptors that enables recognition of a nearly infinite range of pathogens; immune
memory, to mount rapid recall immune responses; and immunologic tolerance, to avoid
6
immune damage to normal self-tissues. The immune system evolved to protect multi-
cellular organisms from pathogens. Highly adaptable, it defends the body against invaders
Conceptual study
as diverse as the tiny (~30 nm), intracellular virus that causes polio and as large as the giant
parasitic kidney worm Dioctophyme renale, which can grow to over 100 cm in length and 10
mm in width. This diversity of potential pathogens requires a range of recognition and
destruction mechanisms to match the multitude of invaders. To accomplish this feat,
vertebrates have evolved a complicated and dynamic network of cells, molecules and
pathways. 7
The immune system of the body consists of two major components:B lymphocytes and T
lymphocytes. The B lymphocytes are mainly derived from bone marrow cells in higher
animals and from the bursa of Fabricius in birds. The T lymphocytes are of thymic origin.
The B cells are responsible for the synthesis of circulating, humoral antibodies, also known
as immunoglobulins. The T cells are involved in a variety of important cell mediated
immunologic processes such as graft rejection, hypersensitivity reactions, and defense
against malignant cells and many viruses. Plasma cells are specialized cells of B cell
lineage that synthesize and secrete immunoglobulins into the plasma in response to
8
exposure to a variety of antigens.
Immune response in Human body against foreign proteins or infectious agents:
Humoral response (B lymphocytes):
The humoral response involves interaction of B cells with foreign proteins, called antigens, and their
differentiation into antibody secreting cells. The secreted antibody binds to foreign proteins or
infectious agents, helping to clear them from the body.
Cell-mediated response (T lymphocytes): The cell mediated response involves various

subpopulations of T lymphocytes, which can perform many functions, including the secretion of
soluble messengers that help direct other cells of the immune system and direct killing of infected
cells.
Development of the Immune System:
The development of the highly specific yet anticipatory human immune system begins with
hematopoiesis and continues throughout the life. The first progenitor cells of the immune
system are found in the yolk sac at approximately 3 weeks of gestational age. These
pluripotential hematopoietic stem cells seed the liver at 5 weeks, and hematopoiesis begins at
6 weeks of gestation. By the 8th week stem cell are migrated to the primary lymphoid
organs, the bone marrow and the thymus. These organs serve as the site for the development
Conceptual study
of the T cells or B cells. Mature T and B cells first migrate to secondary lymphoid tissue, the
lymph nodes, the mucous –membrane associated lymphoid tissue and spleen, at 10-12 weeks
of gestation age. It is in the secondary lymphoid tissues that most mature lymphocyte resides
and where immune responses are generated. Responses to blood borne antigens occur in the
spleen, which is connected to the systemic circulation. Lymphocytes in lymph nodes respond
to antigens delivered from the skin via the lymphatic. The tonsils, the payer’s patches, and
lamina propria of the gut contain lymphocytes that respond to antigens entering through
the mucosal surfaces.9,10
Organs of the immune system:
The immune system is the body's natural defense system that helps fight infections. The
organs of the immune system include: Tonsils, Lymphatics and Lymph nodes, Thymus
gland, Bone Marrow and Spleen.
A successful immune response to a pathogen depends on finely choreographed interactions

among diverse cell types: innate immune cells that mount a first line of defence against
pathogen, antigen-presenting cells that communicate the infection to lymphoid cells, which
coordinate the adaptive response and generate the memory cells, which prevent future
infections. The coordination required for the development of a full immune response is
made possible by the specialized anatomy and microanatomy of the immune system, which
is dispersed throughout the body and organizes cells in time and space. Primary lymphoid
organs— including the bone marrow and the thymus—regulate the development of immune
cells from immature precursors. Secondary lymphoid organs—including the spleen, lymph
nodes, and specialized sites in the gut and other mucosal tissues—coordinate the encounter
of antigen with antigen-specific lymphocytes and their development into effector and
memory cells. Blood vessels and lymphatic systems connect these organs, uniting them
into a functional whole. Remarkably, all functionally specialized, mature blood cells (red
blood cells, granulocytes, macrophages, dendritic cells, and lymphocytes) arise from a single
cell type, the hematopoietic stem cell (HSC). The process by which HSCs differentiate
into mature blood cells is called haematopoiesis. Two primary lymphoid organs are
responsible for the development of stem cells into mature immune cells: the bone
marrow, where HSCs reside and give rise to all cell types; and the thymus, where T cells
complete their maturation. 11

Conceptual study
Cytokines:
Molecules that communicate among cells of the immune system are referred to as
cytokines. In general, cytokines are soluble molecules, although some also exist
in membrane-bound forms. The interaction of a cytokine with its receptor on a
target cell can cause changes in the expression of adhesion molecules and
chemokine receptors on the target membrane, thus allowing it to move from
one location to another. Cytokines can also signal an immune cell to increase
or decrease the activity of particular enzymes or to change its transcriptional
program, thereby altering and enhancing its effector functions. Finally, they can
instruct a cell when to survive and when to die.12
In an early attempt to classify cytokines, immunologists began numbering them in the order
of their discovery, and naming those interleukins. Although the term cytokine refers to all
molecules that communicate among immune cells, the name chemokine is used specifically
to describe that subpopulation of cytokines that share the specific purpose of mobilizing
immune cells from one organ, or indeed, from one part of an organ, to another. Chemokines
belong to the class of molecules called chemoattractants, molecules that attract cells by
influencing the assembly, disassembly, and contractility of cytoskeleton proteins and the
expression of cell- surface adhesion molecules. Chemokines attract cells with the
appropriate chemokine receptors to regions where the chemokine concentration is
highest. For example, chemokines are important in attracting cells of the innate immune
system to the site of infection and inducing T cells to move toward antigen-presenting
cells in the secondary lymphoid tissues. Leukocytes change their pattern of expression of
chemokine receptors over the course of an immune response, first migrating to the secondary
immune organs, in which they undergo differentiation to mature effector cells, and then
moving out into the affected tissues to fight the infection, responding to different chemokine
13
gradients with each movement.
Although a variety of cells can secrete cytokines that instruct the immune system, the
principal producers are TH cells, dendritic cells, and macrophages. Cytokines released from
these cell types are capable of activating entire networks of interacting cells. Among the
numerous physiological responses that require cytokine involvement are the generation of
cellular and humoral immune responses, the induction of the inflammatory response,
13
the regulation of hematopoiesis, and wound healing.
Conceptual study
1. Cell-mediated /Cellular/T cell immunity:
Activation, proliferation and differtiation of T cells-

At any given time most T cells are inactive. There are millions of millions of different
T cells; each has its unique T cell receptor (TCR) that can recognize a specific antigen- major
histocompactibility complex. When antigen enters the body, only a few T cells have TCRs
that can recognize and bind to the antigen. Antigen recognition also involves other surface
proteins on T cells, the CD4 or CD8 proteins. These proteins interact with major
histocompatibility complex (MHC) antigens and help to maintain the TCR-MHC coupling.
Hence CD4 or CD8 proteins are also called as coreceptors. Antigen recognition by the TCR
with CD4 or CD8 proteins is the first signal in the activation of the T cell.14
A T cell becomes activated only if it binds to the foreign antigen and T the same time
receives the second signal, a process known as costimulation. Of the more than 20 known
costimulators, some are cytokines, such as interleukin 2.
Once T cell has received these two signals, it gets activated. An activated T cell enlarges
and begun to proliferate and differentiate. The result is population of the identical cells,
called as clone that can recognize the same specific antigen. Before the first exposure to a
given antigen, only few T cells might be able to recognize it, but once an immune response
has begun, there are thousands. Activation, proliferation and differentiation of T cells occur
in secondary lymphatic organs and tissues (e.g. tonsils, lymph nodes).


Types of T cells-
a) Helper T cells – Most T cells that display CD4 develop into T cells, also known as CD4 T
cells. Within the hours after co stimulation, activated helper T cells start secreting a
variety of cytokines. Different substrates of helper T cells specialize in the production of
particular cytokines. Interleukin 2 is very important cytokine produced by helper T cell,
needed for virtually all immune responses and is the prime trigger of the T cell
proliferation. Interleukin 2 can act as co stimulator for resting helper T cells, and enhance
activation, proliferation of T cells, B cells and natural killer cells. Some action of
interleukin 2 provides a beneficial positive feedback system. Activation of the helper T
cell start secreting interleukin 2, which then acts as autocrin manner by binding to
Interleukin 2 receptor on the plasma membranes of the cell that secreted it. One effect is
stimulation of the cell division. As the helper T cell proliferates the positive feedback
effect occurs because they secrete more Interleukin 2, which cause further cell division.
Interleukin 2 also acts as paracrine manner by binding to Interleukin 2 receptors on
Conceptual study
neighbouring helper T cells, cytotoxic T cells or B cells. If any of these neighbouring

cells have already bound an antigen, Interleukin 2 serves as a costimulator. xv
b) Cytotoxic T cells-
T cells that display CD8 develop into cytotoxic T cells, also termed Cd8 cells.
Cytotoxic T cells recognize foreign antigens combined with major histocompactibity
complex class I molecules on the surfaces of body cells infected by microbes, some
tumor cells and cells of tissue transplant. Following recognition costimulation occurs. In
order to become activated, cytotoxic T cells require costimulation by interleukin 2 and
other cytokines produced by helper T cells. Thus maximum activation of cytotoxic T
cells requires presentation of antigen associated with both MHC-I and MHC-II
molecules.
c) Memory T cells-
T cells that remain from a proliferated clone after a cell mediated tissue response are
termed as memory T cells. A pathogen bearing some foreign antigen invades the body later;
thousands of memory cells are available to initiate a far swifter reaction than occurred during
the first invasion. The second response usually is so fast and so vigorous that the pathogens
are destroyed before any sign or symptom of disease can occur.15
2. Antibody-mediated immunity:
The body contains not only millions of different T cells but also millions of different
B cells, each capable of responding to a specific antigen. Cytotoxic T cells leave lymphatic
tissues to seek out and destroy a foreign antigen. In the presence of the foreign antigen,
specific B cells in lymph nodes, the spleen or mucosa associated lymphatic tissue become
activated. They then differentiate into plasma cell that secretes specific antibodies, which in
turn circulate in the lymph and blood to reach the site of invasion. 15
Activation, proliferation and differentiation of B cells-

During activation of a B cell, an antigen binds to B-cell receptors (BCRs). These
integral transmembrane proteins are chemically similar to the antibodies that eventually are
secreted by plasma cells. Antigen processing in a B cell occurs in the following way: the
antigen is taken into the B cell, broken down into peptide fragments and combined with
MHC-II self-antigens, and moved to the B cell plasma membrane. Helper T cells recognize
the antigen- MHC-II complex and deliver the costimulation needed for B cell proliferation
and differentiation. The helper T cells enhance B cell proliferation and differentiation. The
helper T cell produces interleukin 2 and other cytokines that function as also produced by
Conceptual study
helper T cells, enhance B cell proliferation, B cell differentiation into the plasma cells, and
secretion of antibodies by plasma cells.
Some of the activated B cells enlarge, divide and differentiate into a clone of antibody
secreting plasma cells. A few days after exposure to an antigen, a plasma cell secretes
hundreds of millions of antibodies each day for about 4 or 5 days, until the plasma cells dies.
Most antibodies travel in lymph and blood to the invasion site. Some activated B cells do not
differentiate into plasma cells but remain as memory B cell that are ready to respond more
rapidly and forcefully should the same antigen reappear at a future time.
Different antigens stimulate different B cells to develop into plasma cells and their
accompanying memory B cells. All of the B cells of a particular clone are capable of
secreting only one type of antibody, which is identical to the antigen receptor displayed by
the B cells that are predestined to secrete antibody specific to the antigen. Antibodies
produced by the clone of plasma cells enter the circulation and form antigen-antibody
complexes with the circulation and form antigen-antibody complexes with the circulation and
form antigen-antibody complexes with the antigen that initiated their production.16
Thymus and T cell development-16, 17

The thymus itself is formed from the third brachial cleft and the third/forth brachial
pouch, which may contribute both ectoderm and endoderm. Embryonic tissues from these
locations move caudally to fuse in the midline, forming the two thymic lobes. Each lobe
consists of the three regions with distinct structure and function, the cortex and the cortico-
medullary junction and the medulla. The thymic cortex is composed of specialized epithelial
cell that express class I and class II molecules of the major histocompactibility complex and
mediate the early stages of maturation including positive selection CD1a-, CD5-, CD34+ and
CD38low stem cells enter the thymus at the cortico-medullary junction and migrate into the
cortex. These stem cells are slightly different from those found in fetal marrow in that they
express high levels of CD45RA and CD7.
This implies that the stem cell progeny entering the thymus have undergone some
differentiation since leaving the sites of haematopoiesis. Current data suggest that they may
develop into dendritic cells.
(DC‘s), NK cells or T cells as indicate in bellow figure.

Conceptual study
Monocyte
Granulocyte B cell
CD34+
Erythrocyte stem NK cells cell
T cell Megakaryocyte
Dendritic cell
+ + low
Small double-positive (DP) cells (CD4 , CD8 , TCR ) account for about 75% of all
thymocytes. Maturation beyond this stage depends on the interaction between the unique
TCR on each DP thymocyte and the self-peptide/ MHC complexes expressed on the surface
of thymic epithelial cells.
The stages of T cell development that occurs within the thymus. (SP-single positive,
DP- double positive)-
Early precursor
Pre-T
Immature CD4low sp
Early DP
Late DP
DP Neglect Negative selection
Mature CD4-sp or CD8-sp

Conceptual study
Over the period of the days those T cells that are CD4+ will differentiate into either
TH1 or Th2 effectors. TH1 cell secretes IL-2, interferon gamma, lymphotoxin and tumor
necrosis factor beta. These cytokines synergistically to lyses virally infected cells and activate
macrophages and granulocytes. Factor that induces immunoglobulin heavy chain class
switching to the IgE isotype and uncommitted T cells to differentiate towards the TH-2
phenotype. Interleukin 5 is an allergic response by a number of mechanisms.
NK cell development-
Natural killer cells are a subset of lymphocytes distinguished by their morphology,
function and expression of distinct surface molecules. Mature NK cells are larger than T or B
cells and have a more glandular cytoplasm. The NK cells are identified by their expression of
CD16 and CD56 on the cell surface and comprise 10-15% of circulating lymphocyte. Mature
NK cells can be found in the spleen, lungs and liver. During the first trimester of the
pregnancy they are also found in the placental deciduas.
NK cells first make their appearance in the fetal liver as early as 6 weeks of gestation.
+ -
However committed CD34 , CD56 NK progenitors have been identified in the fetal thymus,
bone marrow and the liver, although the thymus is not clearly required for NK cell
development.
NK development does not require the gene segment rearrangements to generate a
unique receptor. Instead, NK cell can use an array of stimulatory and inhibitory receptors to
trigger their cytolytic functions. A closure of genes preferentially expressed in the human NK
cells has been identified on chromosome 12.
B cell development-
B cell development begins before 7 weeks of gestational age in the fetal liver. By 8-10
weeks, CD34+haemopioetic stem cell migrate to the bone marrow and begin to complex
program of the antigen-independent differentiation. This program can be divided into three
distinct stages. The first progenitor committed to the B cell linkage is called early pro- B
cells. These cells express CD 34 and terminal deoxynucleotidyltransferase (TdT).

Conceptual study
The stages of B-cell development in the bone marrow and spleen.
Early pro-B
Intermediate pro-B
Late pro-B
Bone marrow Large pre-B
Small pre-B
Immature B with IgM elimination
Spleen emigration
Mature B with IgM & IgD recirculation
IgM the first immunoglobulin generated in the primary immune response, is secreted as a
pentamer and is found in the srecretory IgG at mucosal surfaces and the breast milk. Secreted
IgD is present at very low concentrations in human serum and its function is not known.
Memberane IgD is found on the peripheral B cells, where it functions with IgM as an antigen
specific receptor. IgG is most prevalent immunoglobulin in human serum, making up 75-80%
of total Ig. Binding of IgG to the three classes of Fc receptors expressed on the overlapping
sets of macrophages, granulocytes, lymphocytes, NK cells, neutrophills, eosinophills mediate
such function as antibody-dependent cellular cytotoxicity and transfer of IgG from mother to
fetus. IgA makes up 15% of serum Ig. IgA is secreted in saliva, brest milk, tears and
bronchial secretions. IgE is least prevalent Ig in human serum. It plays a role against
defending against parasites and mediates allergic reactions.
Under normal circumstances the first plasma cells can be found in fetal lymphoid tissue
at about 20 weeks of gestation and only small numbers thereafter. Thus, IgG found in fetal
serum is predominately of maternal origin. Transplacental transfer of IgG begins between 8
and 12 weeks of gestation, although levels remain below 100mg/dl until 20 weeks. By 30
Conceptual study
weeks the fetal serum

IgG concentration is about half of the maternal concentration and it ultimately exceeds
the maternal concentration by about 10% at term. Thus, 50 % of IgG transfer takes place in
the last 10 weeks of gestation. Very low levels of IgM and a few nanograms /ml IgA and IgE
can found in cord serum at term. These immunoglobulins are of fetal origin because they do
not cross the placenta. After birth as a consequence of increased antigen exposure, neonatal
Ig synthesis increases as the passively acquired IgG level fall. An IgG nadir of about
400mg/dl reached by 3-4 months of age. Synthesis of all immunoglobulins continues to
increase, reaching adult level at 1 year for IgM, 5-6 years for IgG and adolescence for IgA.
ANTIBODY-
Antibodies (also known as immunoglobulins18, abbreviated Ig) are gamma globulin
proteins that are found in blood or other bodily fluids of vertebrates, and are used by the
immune system to identify and neutralize foreign objects, such as bacteria and viruses. They
are typically made of basic structural units—each with two large heavy chains and two small
light chains—to form, for example, monomers with one unit, dimers with two units or
pentamers with five units. Antibodies are produced by a kind of white blood cell called a
plasma cell. There are several different types of antibody heavy chains, and several different
kinds of antibodies, which are grouped into different isotypes based on which heavy chain
they possess. Five different antibody isotypes are known in mammals, which perform
different roles, and help direct the appropriate immune response for each different type of
19
foreign object they encounter.
Though the general structure of all antibodies is very similar, a small region at the tip of the
protein is extremely variable, allowing millions of antibodies with slightly different tip
structures, or antigen binding sites, to exist. This region is known as the hyper variable
region. Each of these variants can bind to a different target, known as an antigen.20 This
huge diversity of antibodies allows the immune system to recognize an equally wide diversity
of antigens. The unique part of the antigen recognized by an antibody is called an epitope.
These epitopes bind with their antibody in a highly specific interaction, called induced fit
that allows antibodies to identify and bind only their unique antigen in the midst of the
millions of different molecules that make up an organism. Recognition of an antigen by an
antibody tags it for attack by other parts of the immune system. Antibodies can also
neutralize targets directly by, for example, binding to a part of a pathogen that it needs to
21
cause an infection.
The large and diverse population of antibodies is generated by random combinations
of a set of gene segments that encode different antigen binding sites (or paratopes), followed
Conceptual study
22
by random mutations in this area of the antibody gene, which create further diversity.,
Antibody genes also re-organize in a process called class switching that change the base of
the heavy chain to another, creating a different isotype of the antibody that retains the antigen
specific variable region. This allows a single antibody to be used by several different parts of
the immune system. Production of antibodies is the main function of the humoral immune
system.23
 Contents-
 Forms Surface immunoglobulin (Ig) is attached to the membrane of the effector B cells
by its transmembrane region, while antibodies are the secreted form of Ig and lack the
trans membrane region so that antibodies can be secreted into the bloodstream and body
cavities. As a result, surface Ig and antibodies are identical except for the transmembrane
regions. Therefore, they are considered two forms of antibodies: soluble form or
membrane-bound form (Parham 21-22).
The membrane-bound form of an antibody may be called a surface immunoglobulin

(sIg) or a membrane immunoglobulin (mIg). It is part of the B cell receptor (BCR), which
allows a B cell to detect when a specific antigen is present in the body and triggers B cell
activation.24 The BCR is composed of surface-bound IgD or IgM antibodies and associated
Ig-α and Ig-β heterodimers, which are capable of signal transduction. A typical human B
cell will have 50,000 to 100,000 antibodies bound to its surface. Upon antigen binding, they
cluster in large patches, which can exceed 1 micrometer in diameter, on lipid rafts that isolate
the BCRs from most other cell signaling receptors.25 These patches may improve the
efficiency of the cellular immune response.26 In humans, the cell surface is bare around the
B cell receptors for several thousand Ångstroms,xxvi which further isolates the BCRs from
competing influences.
 Isotype
Table No 2.3 Antibody isotypes of mammals-
No. Name Types Description
1. IgA 2 Found in mucosal areas, such as the gut,

respiratory tract and urogenital tract, and prevents
colonization by pathogens.27 Also found in saliva,

tears, and breast milk.
2. IgD 1 Functions mainly as an antigen receptor on B cells
that have not been exposed to antigens.28 It has

been shown to activate basophils and mast cells to

Conceptual study
produce antimicrobial factors.29

3. IgE 1 Binds to allergens and triggers histamine release
from mast cells and basophils, and is involved in
24
allergy. Also protects against parasitic worms.
4. IgG 4 In its four forms, provides the majority of
antibody-basedimmunity againstinvading
24
pathogens. The only antibody capable of
crossing the placenta to give passive immunity to
fetus.
5. IgM 1 Expressed on the surface of B cells and in a

secreted form with very high avidity. Eliminates
pathogens in the early stages of B cell mediated
(humoral) immunity before there is sufficient
IgG.24,29
Antibodies can come in different varieties known as isotypes or classes. In placental

mammals there are five antibody isotypes known as IgA, IgD, IgE, IgG and IgM. They are
each named with an "Ig" prefix that stands for immunoglobulin, another name for antibody,
and differ in their biological properties, functional locations and ability to deal with different
30
antigens, as depicted in the table.
The antibody isotype of a B cell changes during cell development and activation. Immature
B cells, which have never been exposed to an antigen, are known as naïve B cells and express
only the IgM isotype in a cell surface bound form. B cells begin to express both IgM and IgD
when they reach maturity—the co-expression of both these immunoglobulin isotypes renders the
B cell 'mature' and ready to respond to antigen.31
B cell activation follows engagement of the cell bound antibody molecule with an antigen,
causing the cell to divide and differentiate into an antibody producing cell called a plasma
cell. In this activated form, the B cell starts to produce antibody in a secreted form rather
than a membrane-bound form. Some daughter cells of the activated B cells undergo isotype
switching, a mechanism that causes the production of antibodies to change from IgM or IgD
to the other antibody isotypes, IgE, IgA or IgG, that have defined roles in the immune
system.

Conceptual study
 Structure 
Antibodies are heavy (~150kDa) globular plasma proteins. They have sugar chains
added to some of their amino acid residues.32 In other words, antibodies are glycoproteins.
The basic functional unit of each antibody is an immunoglobulin (Ig) monomer (containing
only one Ig unit); secreted antibodies can also be dimeric with two Ig units as with IgA,
tetrameric with four Ig units like teleost fish IgM, or pentameric with five Ig units, like
33
mammalian IgM.
Immunoglobulin domains -The Ig monomer is a "Y"-shaped molecule that consists of four
polypeptide chains; two identical heavy chains and two identical light chains connected by
23
disulfide bonds. Each chain is composed of structural domains called Ig domains. These
domains contain about 70-110 amino acids and are classified into different categories (for
example, variable or IgV, and constant or IgC) according to their size and function. 34 They
have a characteristic immunoglobulin fold in which two beta sheets create a ―sandwich‖
shape, held together by interactions between conserved cysteines and other charged amino
acids.
 Heavy chain - There are five types of mammalian Ig heavy chain denoted by the Greek
21
letters: ?, δ, ε, γ, and μ. The type of heavy chain present defines the class of antibody;
22
these chains are found in IgA, IgD, IgE, IgG, and IgM antibodies, respectively.
Distinct heavy chains differ in size and composition; α and γ contain approximately 450
21
amino acids, while μ and ε have approximately 550 amino acids. 
 Light chain - In mammals there are two types of Immunoglobulin light chain, which are
21
called lambda (λ) and kappa (κ) . A light chain has two successive domains: one
constant domain and one variable domain. The approximate length of a light chain is 211
21
to 217 amino acids. Each antibody contains two light chains that are always identical;
only one type of light chain, κ or λ, is present per antibody in mammals.
 CDRs, Fv, Fab and Fc Regions - Some parts of an antibody have unique functions. The
tips of the Y, for example, contain the site that bind antigen and, therefore, recognize
specific foreign objects. This region of the antibody is called the Fab (fragment, antigen
binding) region. It is composed of one constant and one variable domain from each heavy
and light chain of the antibody.35 The paratope is shaped at the amino terminal end of
the antibody monomer by the variable domains from the heavy and light chains. The
variable domain is also referred to as the FV region and is the most important region for
binding to antigens. More specifically variable loops, three each on the light (VL) and heavy
(VH) chains are responsible for binding to the antigen. 

Conceptual study

These loops are referred to as the Complementarity Determining Regions 
(CDRs).The base of the Y plays a role in modulating immune cell activity. This region is
called the Fc (Fragment, crystallizable) region, and is composed of two heavy chains
11
that contribute two or three constant domains depending on the class of the antibody.
By binding to specific proteins the Fc region ensures that each antibody generates an
appropriate immune response for a given antigen.36 The Fc region also binds to various
cell receptors, such as Fc receptors, and other immune molecules, such as complement
proteins. By doing this, it mediates different physiological effects including
,37
opsonization, cell lysis, and degranulation of mast cells, basophils and eosinophils.
Glycosylation of the antibody Fc fragment is essential for Fc receptor-mediated activity. 38
 Antibody actions- 
The actions of the five classes of immunoglobulins differ somewhat, but all them act
to disable antigens in some way. Actions of antibodies include39
a. Neutralizing antigen- the reaction of antibody with antigen blocks or neurilizes some
bacterial toxics and presents attachment of some bacterial toxins and prevents
attachment of some virues to body cells
b. Immobilizing bacteria- if antibodies from against antigen on cilia or flagella of motile
bacteria, the antigen-antibody reaction may cause the bacteria to lose their motility,
which limits their spread into nearby tissues.
c. Aggulitinating and participating antigen- because antibodies have two or more sites
for binding to antigen, the antigen-antibody reaction may cross-link pathogens to one
another, causing agglutination. Phagocytic cells ingest agglutinated microbes more
readily. Soluble antigens may come out of solution and form a more-easily
phagocytised precipitate when cross-linked by antibodies.
d. Activating complement- antigen antibody complexes initiate the complement system.
e. Enhancing phagocytosis- the stem region of an antibody acts as a ‗flag‘ that attracts
phagocytes once antigens have bound to the antibody‘s variable region. Antibodies
enhance the activity of phagocytes by causing agglutination and precipitation, by
activating complement and by coating microbes so that they are more susptible to
phagocytosis.
Medical applications

Conceptual study
Disease diagnosis and therapy-

i. Detection of particular antibodies is a very common form of medical
diagnostics, and applications such as serology depend on these methods.40 For example,
in biochemical assays for disease diagnosis,41 a titer of antibodies directed against
Epstein-Barr virus or Lyme disease is estimated from the blood.
ii. In clinical immunology, levels of individual classes of immunglobulins are measured
by nephelometry (or turbidimetry) to characterize the antibody profile of patient.42
Elevations in different classes of immunoglobulins are sometimes useful in
determining the cause of liver damage in patients whom the diagnosis is unclear. For
example, elevated IgA indicates alcoholic cirrhosis, elevated IgM indicates viral
hepatitis and primary biliary cirrhosis, while IgG is elevated in viral hepatitis,
autoimmune hepatitis and cirrhosis.
iii. Autoimmune disorders can often be traced to antibodies that bind the body's own
epitopes; many can be detected through blood tests.
iv. Antibodies directed against red blood cell surface antigens in immune mediated
hemolytic anemia are detected with the Coombs test.43 The Coombs test is also used
for antibody screening in blood transfusion preparation and also for antibody
screening in antenatal women.44
v. Practically, several immunodiagnostic methods based on detection of complex
antigen-antibody are used to diagnose infectious diseases, for example ELISA,
immunofluorescence, Western blot, immunodiffusion, immunoelectrophoresis, and
Magnetic immunoassay.
vi. Antibodies raised against Human chorionic gonadotropin are used in over the counter
pregnancy tests.
vii. Targeted monoclonal antibody therapy is employed to treat diseases such as
rheumatoid arthritis,45 multiple sclerosis,46 psoriasis,47 and many forms of cancer
including non-Hodgkin's lymphoma,48 colorectal cancer, head and neck cancer and
breast cancer.49
viii. Some immune deficiencies, such as X-linked agammaglobulinemia and

50
hypogammaglobulinemia, result in partial or complete lack of antibodies. These
diseases are often treated by inducing a short term form of immunity called passive
immunity. Passive immunity is achieved through the transfer of ready-made
antibodies in the form of human or animal serum, pooled immunoglobulin or
monoclonal antibodies, into the affected individual.51
ix. Prenatal therapy- Rhesus factor, also known as Rhesus D (RhD) antigen, is an antigen

Conceptual study
found on red blood cells. During normal childbirth, delivery trauma or complications
during pregnancy, blood from a fetus can enter the mother's system. In the case of an
Rh-incompatible mother and child, consequential blood mixing may sensitize an Rh-
mother to the Rh antigen on the blood cells of the Rh+ child, putting the remainder of
the pregnancy, and any subsequent pregnancies, at risk for hemolytic disease of the
newborn.52
x. Rho(D) immune globulin antibodies are specific for human Rhesus D (RhD) antigen. 53
Anti-RhD antibodies are administered as part of a prenatal treatment regimen to prevent
sensitization that may occur when a Rhesus-negative mother has a Rhesus-positive
fetus.
IMMUNOGLOBULIN G-
Immunoglobulin G (IgG) is the antibody molecule. Each IgG is composed of four
peptide chains -- two heavy chains γ and two light chains. Each IgG has two antigen
binding sites. Other Immunoglobulins may be described in terms of polymers with the IgG
structure considered the monomer.IgG constitutes 75% of serum immunoglobulins in
humans54. IgG molecules are synthesized and secreted by plasma B cells.
Structure-
IgG antibodies are large molecules of about 150 kDa composed of 4 peptide chains.
It contains 2 identical heavy chains of about 50 kDa and 2 identical light chains of about 25
kDa, thus tetrameric quaternary structure. The two heavy chains are linked to each other and
to a light chain each by disulfide bonds. The resulting tetramer has two identical halves
which together form the Y-like shape. Each end of the fork contains an identical antigen
binding site. The Fc regions of IgGs bear a highly conserved N-glycosylation site. The N-
glycans attached to this site are predominantly core-fucosylated diantennary structures of the
complex type. Additionally, small amounts of these N-glycans also bear bisecting GlcNAc
and α-2,6 linked sialic acids residues55.
Subclasses
There are four IgG subclasses (IgG1, 2, 3 and 4) in humans, named in order of their
abundance in serum (IgG1 being the most abundant).
Name Percent Crosses placenta Complement Binds to Fc receptor on

easily activator phagocytic cells
Conceptual study
IgG1 66% yes (1.47)† second highest high affinity
IgG2 23% no (0.8)† third highest extremely low affinity
IgG3 7% yes (1.17)† Highest high affinity
IgG4 4% yes (1.15)† No intermediate affinity
Quota cord/maternity concentrations blood. Based on data from a japanese

study on 228 mother56.
Functions
 IgG antibodies are predominantly involved in the secondary immune response (the
main antibody involved in primary response is IgM). The presence of specific IgG
generally corresponds to maturation of the antibody response57. 

 Human IgG Subclasses: IgG is the only isotype that can pass through the human
placenta, thereby providing protection to the fetus in utero. Along with IgA secreted
in the breast milk, residual IgG absorbed through the placenta provides the neonate
with humoral immunity before its own immune system develops. Colostrum
contains a high percentage of IgG, especially in bovine colostrum. 

 IgG can bind to many kinds of pathogens, for example viruses, bacteria, and fungi,
and protects the body against them by agglutination and immobilization,
complement activation (classical pathway), opsonization for phagocytosis and
neutralization of their toxins. 

 It also plays an important role in Antibody-dependent cell-mediated
cytotoxicity(ADCC) and Intracellular antibody-mediated proteolysis, in which it
binds to TRIM21 (the receptor with greatest affinity to IgG in humans) in order to
direct marked virions to the proteasome in the cytosol58. 
 IgG is also associated with Type II and Type III Hypersensitivity. 
SUBLINGUAL IMMUNOTHERAPHY-
Sublingual Immunotherapy (SIT) is method of allergy treatment that uses an allergen
solution given under the tongue, which over the course of treatment, reduces sensitivity to
allergens. Sublingual immunotherapy, or SLIT, has a very good safety profile and is given at
home in adults and children59.It is the practice of administering gradually increasing doses of
the specific causative allergen to reduce the clinical reactivity of allergic subjects, and is the

Conceptual study
only treatment targeting the causes of hypersensitivity and not only the symptoms, as done by
drugs60. The traditional, subcutaneous immunotherapy (SCIT) was burdened by the problem
of systemic reactions which may be sometimes severe and - though very rarely - even fatal61.
This was the background to develop non injections routes for SIT and particularly sublingual
immunotherapy (SLIT), that emerged as a real treatment option for respiratory allergy62. A
number of studies was conducted to evaluate efficacy and safety of SLIT, the first meta-
analysis - including 22 placebo-controlled trials - concluded for positive results in both
issues, but the number of studies on children was too low to draw definite conclusions63.
Efficacy of Slit in Children
The clinically efficacy of SLIT, as of SIT in general, is evaluated by the decrease in
symptom scores of rhinitis and asthma and in consumption of symptomatic drugs. Many
placebo-controlled studies are conducted on small patient populations and cannot achieve a
reliable statistical significance, but their combined evaluation by the tool of meta-analysis is
considered an adequate method to obtain more robust data64. The results obtained by the
Cochrane Collaboration method65 are expressed as standardized mean difference (SMD) and
allow comparing the effect of SLIT on actively and placebo treated patients. Also systematic
reviews, that is, literature analysis without using the Cochrane method, are available.
Safety of Slit in Children

All systematic revisions and meta-analysis found that the most common adverse
events to SLIT, regardless the age, are local reactions in the oropharynx - with itching,
tingling and swelling in the mouth - followed by local gastrointestinal reactions - with
nausea, vomiting or diarrhea - and that systemic reactions such as asthma, rhinitis, or
urticaria, are quite rare66,67,68. An increased risk of systemic reactions is apparent in subjects
undergoing SLIT because of previous systemic reactions to SCIT 69,70. In particular, one of
the cases of anaphylaxis concerned a pediatric patient, who had had urticaria to previous
SLIT treatment and developed an anaphylactic reaction after the very first dose of a grass
pollen tablet formulation with no updosing phase. Some studies addressed specific safety
issues in children. SLIT was well tolerated using ultra-rush schedules - that reach the
maintenance dose in a few hours71- and also starting the treatment during the pollen season72.
Two studies demonstrated that SLIT is safe also in children younger than 5 years (that is the
age limit indicated for SCIT), as assessed by comparable rate and kind of adverse effects in
patients aged less or more than 5 years73. A further observation regarded children treated with
one or multiple allergen extracts, who showed comparable rates of side effects, more than
90% being mild and self-resolving74.

Conceptual study
Mechanism
Sublingual immunotherapy is taken as drops or tablets, placed under the tongue 3 or
more times/week, containing a specific allergen which interacts with the immune system to
decrease allergic sensitivity. Commonly the allergen is taken once a day. The antigen persists
on the mucosal surface and is taken up by dendritic cells which interact with T lymphocytes
(T-cells). Sublingual immunotherapy takes advantage of each individual‘s ability to develop
immunologic tolerance to non- pathogenic antigens such as those in foods and in resident
bacteria. Consider the vast number of antigens we are exposed to every day which do not
elicit an allergic response. Dendritic cells in the oral mucosa act as antigen presenting cells
(APC) to T-cells in the cervical lymph nodes. This system modulates the allergic response by
creating immune tolerance to antigens. The sublingual mucosa also has proinflammatory
cells, such as mast cells, which is the reason that SLIT sometimes results in local reactions.
The dose progression used is critical to the relative safety margin of sublingual therapy. Early
in treatment, sublingual dendritic cells secrete interleukin 10 (IL-10) which induces
regulatory T cells to inhibit the inflammatory response. Long term changes that occur with
immunotherapy include a decrease in mast cell sensitivity and a decrease in IgE production
by B-cells. With sublingual immunotherapy there is a decrease in the IgE/IgG4 and a
decrease in the TH1/TH2 ratio. Allergic symptoms improve as the underlying basis of the
allergic disease improves.75
Comparison to other allergy management regimens

Options for managing allergy include avoiding what you're allergic to, such as not
eating a food you have a known problem with, avoiding pets, etc. Many allergens are
unavoidable due to the widespread nature of dust, molds, pollens, weeds, and various food
elements in packaged and processed foods. A limitation of avoidance is that low levels of
exposure to antigens allows the immune system to modulate the allergic sensitivity through
T regulatory cells which are short lived. The allergic sensitivity persists much longer so that
intermittent exposure is more problematic than frequent low level exposure. Symptomatic
treatment options for allergies include over the counter medications such as antihistamines,
prescription oral medication, nasal sprays and short-term prednisone. Biologics such as anti-
IgE anti-bodies have been used in severe cases. While there is a role for all of these options,
Allergy immunotherapy is the only treatment directed at resolving the underlying cause of
allergy symptoms76.

Conceptual study
SUBLINGUAL OR BUCCAL ROUTE OF ADMISTRATION-

Within the oral mucosal cavity, the buccal region offers an attractive route of
administration for systemic drug delivery in which the drug is placed under tongue or crushed
in the mouth and spread over the buccal mucosa.77The mucosa has a rich blood supply and it
is relatively permeable. Amongst the various routes of drug delivery, oral route is perhaps the
most preferred to the patient and the clinician alike. However, peroral administration of drugs
has disadvantages such as hepatic first pass metabolism and enzymatic degradation within the
GI tract, that prohibit oral administration of certain classes of drugs especially peptides and
proteins. Consequently, other absorptive mucosae are considered as potential sites for drug
administration. Transmucosal routes of drug delivery (i.e., the mucosal linings of the nasal,
rectal, vaginal, ocular, and oral cavity) offer distinct advantages over peroral administration
for systemic drug delivery. These advantages include possible bypass of first pass effect,
avoidance of presystemic elimination within the GI tract, and, depending on the particular
drug, a better enzymatic flora for drug absorption.
Within the oral mucosal cavity, delivery of drugs is classified into three categories: (i)
sublingual delivery, which is systemic delivery of drugs through the mucosal membranes
lining the floor of the mouth, (ii) buccal delivery, which is drug administration through the
mucosal membranes lining the cheeks (buccal mucosa), and (iii) local delivery, which is
drug delivery into the oral cavity.
Mechanism of Buccal Routes of Drug Absorption:

There are two permeation pathways for passive drug transport across the oral mucosa:
paracellular and transcellular routes. Permeants can use these two routes simultaneously, but
one route is usually preferred over the other depending on the physicochemical properties of
the diffusant. Since the intercellular spaces and cytoplasm are hydrophilic in character,
lipophilic compounds would have low solubilities in this environment. The cell membrane,
however, is rather lipophilic in nature and hydrophilic solutes will have difficulty permeating
through the cell membrane due to a low partition coefficient. Therefore, the intercellular
spaces pose as the major barrier to permeation of lipophilic compounds and the cell
membrane acts as the major transport barrier for hydrophilic compounds. The sublingual
mucosa is relatively permeable, giving rapid absorption and acceptable bioavailabilities of
many drugs, and is convenient, accessible, and generally well accepted.78

Conceptual study
IMMUNIZATION:
Immunization is a means of providing specific protection against many common and
damaging pathogens by stimulating an organism's immune system to either produce humoral
antibodies against the pathogen (or toxins produced by the pathogen) or T cells that can
provide cell-mediated immunity. The type of immunity that is needed to neutralize a specific
pathogen depends on the site of the pathogen and the mechanism of its
79
pathogenesis. Immunization is the process of eliciting a long-lived state of protective
80
immunity against a disease-causing pathogen. Specific immunity can result from
either passive or active immunization and both modes of immunization can occur by
natural or artificial processes.
Artificially acquired passive immunity:

Immunity is often artificially transferred by injection with gamma-globulins from other
individuals or gamma-globulin from an immune animal. Passive transfer of immunity with
immune globulins or gamma-globulins is used in numerous acute situations of infection
(diphtheria, tetanus, measles, rabies, etc.), poisoning (insects, reptiles, botulism), and as a
prophylactic measure (hypogammaglobulinemia). In these situations, gamma-globulins of
human origin are preferable, although specific antibodies raised in other species are effective
and used in some cases (poisoning, diphtheria, tetanus, gas gangrene, botulism). While this
form of immunization has the advantage of providing immediate protection, heterologous
gamma-globulins are effective for only a short duration and often result in pathological
complications (serum sickness) and anaphylaxis. Homologous immunoglobulins also carry
the risk of transmitting hepatitis and HIV.
Passive transfer of cell-mediated immunity can also be accomplished in certain

diseases (cancer, immunodeficiency). However, it is difficult to find histocompatible
80
(matched) donors and there is severe risk of graft versus host disease.
Artificially acquired active immunity:

Immunization may be achieved by administering live or dead pathogens or their components.
Vaccines used for active immunization consist of live (attenuated) Organigms, killed whole
organisms, microbial components or secreted toxins (which have been detoxified). 80
Live vaccine:

Conceptual study
The first live vaccine was cowpox virus introduced by Edward Jenner as a vaccine for
smallpox (see vaccine section); however, variolation (innoculation using pus from a patient
with a mild case of smallpox) has been in use for over a thousand years.
Live vaccines are used against a number of viral infections (polio (Sabin vaccine), measles,
mumps, rubella, chicken pox, hepatitis A, yellow fever, etc.). The only example of live
bacterial vaccine is one against tuberculosis (Mycobacterium bovis: Bacille Calmette-Guerin
vaccine: BCG). This is used in many African, European and Asian countries but not in the
United States. Whereas many studies have shown the efficacy of BCG vaccine, a number of
80
studies also cast doubt on its benefits.
Live vaccines normally produce self-limiting non-clinical infections and lead to subsequent
immunity, both humoral and cell-mediated, the latter being essential for intracellular
pathogens. However, they carry a serious risk of causing overt disease in
immunocompromised individuals. Furthermore, since live vaccines are often
attenuated (made less pathogenic) by passage in animals or thermal mutation, they can revert
to their pathogenic form and cause serious illness. It is for this reason that live polio (Sabin)
vaccine, which was used for many years, has been replaced in many countries by the
80
inactivated (Salk) vaccine.
Killed Vaccine:
Another common means to make a pathogen safe for use in a vaccine is by treatment with
heat or chemicals. This kills the pathogen, making it incapable of replication, but still allows
it to induce an immune response to at least some of the antigens contained within the
organism. 81 Killed viral vaccines include those for polio (Salk vaccine), influenza, rabies,
influenza, rabies, etc. Most bacterial vaccines are killed organisms (typhoid, cholera, plague,
pertussis, etc.).
Sub unit vaccine
Many of the risks associated with attenuated or killed whole organism vaccines can be
avoided with a strategy that uses only specific, purified macromolecules derived from the
pathogen. The three most common applications of this strategy, referred to as a subunit
vaccine, are inactivated exotoxins or toxoids, capsular polysaccharides or surface
81
glycoproteins, and key recombinant protein antigens. Some anti-bacterial vaccines utilize
purified cell wall components (haemophilus, pertussis, meningococcus, pneumococcus,
etc.). Some viral vaccines (hepatitis-B, etc.) consist of purified antigenic proteins
Conceptual study
manufactured after expression from a gene cloned into a suitable vector (e.g., yeast). When
the pathogenic mechanism of an agent involves a toxin, a modified form of the toxin (toxoid,
which has lost its toxicity while remaining immunogenic) is used as a vaccine (e.g.,
diphtheria, tetanus, cholera). These subunit vaccines are designed to reduce the toxicity
80
problems. Each type of vaccine has its own advantages and disadvantages.
Other Novel Approaches:

A number of novel approaches to active immunization are in the investigative stage and
are used only experimentally. These include anti-idiotype antibodies, DNA vaccines and
immunodominant peptides (recognized by the MHC molecules) and may be available in the
80
future.
 Anti-idiotype antibodies against polysaccharide antibodies produce long lasting
immune responses with immunologic memory.
 DNA vaccines (viral peptide genes cloned into vectors) must be injected. They transfect
host cells and consequently produce a response similar to that produced against live-
attenuated viruses (both cell-mediated and humoral). Several anti-HIV DNA vaccines
have been developed but none has so far shown much efficacy.
 Immunodominant peptides are simple and easy to prepare and, when
incorporated into MHC polymers, can provoke both humoral and cell mediated
responses.
Table No 2.4:Routine Immunization Schedule:-
Age Indian Academy of Paediatric National Immunijation
82
Completed weeks/ schedule Schedule (vaccines)83
Months / Years (Vaccines)
At Birth BCG, OPV-0, Hep-B1 BCG, OPV
6 weeks DTwP1, IPV1, Hep-B1, Hib1, DPT, OPV
Rotavirus1, PCV1
10 weeks DTwP2, IPV2, Hib 2, Rotavirus2, PCV2 DPT, OPV
14 weeks DTwP3, IPV3, Hib 3, Rotavirus3, PCV3 DPT, OPV
6 Months OPV-1, Hep-B3 OPV
9 Months OPV-2, MMR-1 Measles, OPV
9-12 Months Typhoid Conjugated vaccine -
12 Months Hep-A1 -

Conceptual study
15 Months MMR-2, Varicella 1, PCV booster DPT booster, OPV

16 to 18 Months DTwPB1/ DTaPB1, IPVB1, Hib B1 DPT booster
18 Months Hep-A2 -
2 years Typhoid booster -
4-6 years DTwPB2/DTaPB2, OPV3, Varicella2 DPT, OPV
Typhoid booster.
10-12 years T dap/TdHPV TT
Adverse effects of immunization:
Active immunization may cause fever, malaise and discomfort. Some vaccine may
also cause joint pains or arthritis (rubella), convulsions, sometimes fatal (pertussis), or
neurological disorders (influenza). Allergies to egg may develop as a consequence of viral
vaccines produced in egg (measles, mumps, influenza, yellow fever). Booster shots result in
more pronounced inflammatory effects than the primary immunization.
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12970812. Retrived on 4/12/2015.
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Junqueira, Luiz C.; Jose Carneiro (2003). Basic Histology. McGraw-Hill. ISBN 0838505902.
Wikipedia.com on 10/2/2011
55
Stadlmann J, Pabst M, Kolarich D, Kunert R, Altmann F. (2008) Analysis of immunoglobulin
glycosylation by LC-ESI-MS of glycopeptides and oligosaccharides. Proteomics. 2008
Jul;8(14):2858-71 Wikipedia.com on 10/2/2011.
56
Hashira S, Okitsu-Negishi S, Yoshino K. Placental transfer of IgG subclasses in a Japanese
population. Pediatr Int. 2000 Aug;42(4):337-42. PMID: 10986861 Pubmed.com on 10/2/2015.
57
Meulenbroek, A.J.; Zeijlemaker, W.P. (1996). Wikipedia.com on 10/2/2014.
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Mallery DL, McEwan WA, Bidgood SR, Towers GJ, Johnson CM, James LC (2010).
"Antibodies mediate intracellular immunity through tripartite motif-containing 21 (TRIM21)".
Proc. Natl. Acad. Sci. U.S.A. .PMID 21045130. HYPERLINK
"http://www.pnas.org/content/early/2010/11/01/1014074107"
http://www.pnas.org/content/early/2010/11/01/1014074107. Pubmed.com on 11/2/15.
59
Gidaro G, Marcucci F, Sensi L, Incorvaia C, Frati F, Ciprandi G (2005). "The safety of
sublingual- swallow immunotherapy: an analysis of published studies". Clin Exp Allergy 35 (5):
565–71. doi:10.1111/j.1365-2222.2005.02240.x. PMID 15898976. [PubMed] on 8/2/2015.
60
Bousquet J, Lockey R, Malling HJ: Allergen immunotherapy: therapeutic vaccines for allergic
diseases. A WHO position paper. J Allergy Clin Immunol 1998 , 102:558-62. PubMed on
8/2/2015.

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Lockey RF, Nicoara-Kasti GL, Theodoropoulos DS, Bukantz SC: Systemic reactions and
fatalities associated with allergen immunotherapy. Ann Allergy Asthma Immunol 2001 , 87(suppl
1):47-55.
62
Canonica GW, Passalacqua G: Noninjection routes for immunotherapy. J Allergy Clin Immunol
2003 , 111:437-48. PubMed on 8/2/2015.
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Wilson DR, Torres-Lima M, Durham S: Sublingual immunotherapy for allergic rhinitis:
systematic review and meta-analysis. Allergy 2005 , 60:4-12. PubMed on 8/2/2015.
64
Shekelle PG, Woolf SH, Eccles M, Grimshaw J: Clinical guidelines: developing guidelines. BMJ
1999 , 318:593-96. PubMed on 8/2/2015.
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Wilson D, Torres-Lima M, Durham S: Sublingual immunotherapy for allergic rhinitis. Cochrane
Database of Systematic Reviews 2003 , (2):CD002893. DOI:
10.1002/14651858.CD002893.Pubmed on 8/2/2015.
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André C, Vatrinet C, Galvain S, Carat F, Sicard H: Safety of sublingual swallow immunotherapy
in children and adults. Int Arch Allergy Immunol 2000 , 121:229-234. PubMed on 8/2/2015.
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Gidaro GB, Frati F, Sensi L, Incorvaia C, Frati F, Ciprandi G: The safety of sublingual-swallow
immunotherapy: an analysis of published studies. Clin Exp Allergy 2005 , 35:565-571. PubMed
on 8/2/2015.
68
Passalacqua G, Guerra L, Compalati E, Canonica GW: The safety of allergen specific sublingual
immunotherapy. Curr Drug Saf 2007 , 2:117-23. PubMed on 8/2/2015.
69
de Groot H, Bijl A: Anaphylactic reaction after the first dose of sublingual immunotherapy with
grass pollen tablet. Allergy 2009 , 64:963-4. PubMed on 8/2/2015.
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Cochard MM, Eigenmann PA: Sublingual immunotherapy is not always a safe alternative to
subcutaneous immunotherapy. J Allergy Clin Immunol 2009 , 124:378-9. PubMed on 8/2/2015.
71
Tripodi S, Di Rienzo Businco A, Benincori N, Scala G, Pingitore G: Safety and tolerability of
ultra-rush induction, less than one hour, of sublingual immunotherapy in children. Int Arch
Allergy Immunol 2005 , 139:149-152. PubMed on 8/2/2015.
72
Ariano R, Incorvaia C, La Grutta S, Marcucci F, Pajno G, Sensi L, et al.: Safety of sublingual
immunotherapy started during the pollen season. Curr Med Res Opin 2009 , 25:103-7. PubMed
on 8/2/2015.
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Fiocchi A, Pajno G, La Grutta S, Pezzuto F, Incorvaia C, Sensi L, et al.: Safety of SLIT in
children aged 3 to 7 years. Ann Allergy Asthma Immunol 2005 , 95:254-258. PubMed on
8/2/2015.
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63:1637-9. PubMed on 8/2/2015.
75
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of allergen-specific sublingual immunotherapy". Allergy 61 (2): 151–65. doi:10.1111/j.1398-
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delivery, in eds. M.J. Rathbone, Oral Mucosal Drug Delivery, Marcel Dekker, Inc., New York,
New York, 1-26, 1996. Pubmed on 9/2/2014.

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79
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83
www.media.net National immunization [ retrieved on 15.5.16]

Drug Review
DRUG REVIEW
INTRODUCTION:
Drug is the most important tool of a physician. Using drugs without its proper
knowledge is similar to like using a poison, in the same time, if proper knowledge is
there then even a strong poison can become a medicine. Ayurvedic treatise speaks
about the importance of drugs as "Nothing in the world exists which does not have
therapeutic utility."1 Taking this fact into consideration Ayurvedic physician has
formulated single as well as compound drugs for care as well as prevention of various
ailments. These drugs act on the principles of Samanya (homologous) and Visesha
(antagonistic) i.e. substances possessing homologous properties and actions increase
the relevant elemental properties or constituents of the body while those having
antagonistic properties or actions decrease those properties or constituents. In cases of
disease or imbalance of dosha, dhatu and mala, the rational use of naturally available
substances aims to restore normality.2
The description of Swarnaprashana in detail has been given in sutrasthana

Lehadhyaya of Kashyapa Samhita3. Acharya Kashyapa described that consuming of
gold increases intellect, digestive and metabolic power, physical strength, give long
life; is auspicious, increase complexion and immunity in neonates. Swarnaprashana
Yoga prepared in the present study contained Swarna Bhasma, Madhu and Ghrita in a
specific proportion which was modified into drops for convenient administration in
neonates enrolled in the clinical study. The efficacy and safety of Swarnaprashana
therapy entirely depends upon the quality of Swarna bhasma, Madhu and Ghrita.
Hence standardized Swarna bhasma along with superior quality of Madhu and Ghrita
should be used for the preparation of Swarnaprashana Yoga.
The review of the ingredients of Swarna Prashana i.e. Swarna Bhasma,

Madhu (honey) and Goghrita (cow ghee) are dealt in detail in this section.
Swarna (Gold):
Swarna in the Vedas, was mentioned in the name Hiranya, a synonymous

word of gold. The relation between Hiranya and Surya is available in Rig Veda where
it is mentioned that Ratha Chakra (Wheel of Chariot) of Surya 4 is made by gold. In
Samhita period basically in Charaka Samhita, 5 the properties of gold and its
Drug Review
compound formulations such as Lauha Rasayana are mentioned. Sushruta Samhita6

has included Swarna under Parthiva Dravya and has mentioned the properties of
Swarna as Tridosahara, Visapaham, Brumhaniya, Chakhshushya, Rasayana, Hrudya,
Madhura Rasa and Shita Virya. Also in Trapvadi gana7, Garahara, Krimihara,
Pipasa, Visha, Hridrog, Pandughna and Pramehahara gana. In Astanga Hridaya,
Swarna is including under Madhuragana8 and in Ashtanga Samgraha it is included
under Bhauma dravya.9Sharangadhara Samhita explains gold as one among the
Dhatu.10 Bhavaprakasha also depicts gold as one among the Sapta Dhatu
11
which is found in mountains i.e. obtained by mining.
Rasaratnasamuchchaya grouped gold under Shudhaloha (pure metals).12Swarna is

explained as one among the Saptaloha (Seven metals) in Rasatarangini.13
SYNONYMS:
Swarnam, Suvarana, Kanaka, Hiranya, Hema, Haataka, Tapaneeya,

Shatakumbha, Gangeya, Bharma, Karvura, Chameekara, Jatarupa, Maharajata,
Kanchana, Rukma, Kartaswara, Jambunada, Ashtaapada.14
In Bhavaprakasha there are 16 synonyms given for gold among

15
which except Kaladhauta and Chamikara are similar with the above reference.
Rasatarangini adds a few more synonyms to the previous list such as,
Dravina, Kalyanaka, Agnivarna, Manohara, Bhushanarha, Agnibija, Kraunta,
16
Bhrungara, Mangalyaka, Jambava, Champeyaka and Lohavara.
Utpatti - According to ancient texts, gold is the byproduct of Virya (semen) of

Agnideva (God of fire) 17
Varieties and places of origin 18: Acc. To the Rasaratnasammuchchaya-
 Prakrita (Natural)
 Sahaja (from mine)
 Vahnisambhuta (from Agni)
 Khanija (from mines)
 Rasa Vedhaja (from mercurial transformation following alchemy techniques)
Grahyatva and Agrahyatva19:

Drug Review
It becomes red on heating, looks white on cutting, yellow like Kesara, on

rubbing over Nikasa, Guru (heavy), Mrudu (soft), Snigdha (smooth), does not contain
impurities like copper or silver is considered as Grahya (superior in quality) The
Swarna which looks white, Kathina, colourless, white in colour on heating, Laghu
(light) in weight is not considered for medicinal purpose i.e. Agrahya. 19
Shodhana (Purification):
In general gold is considered as the purest among all the metals and it need not to be
purified further. However the gold, which is of Hina Varna (of less lustre,
which could be of less than 24 carat purity), needs purification. It is clearly
mentioned in the classics that gold should be used internally only after proper
purification. If gold is administered in impure form, it will cause deterioration of
Budhi, Bala etc. and will result in many types of diseases.20If gold is administered
in its impure form it will destroy happiness, potency and strength of an individual.
Pure gold is like nectar and thus it should be used for Marana (incineration). 21
Method of Shodhana:
There are many types of purification methods explained by different texts. General
methods explained for purification of metals can be employed in case of gold which
are as given below-
1. Thin sheets of gold are made red hot and immersed in sesame oil, buttermilk, cow’s
urine, Aranala (sour preparation of rice wash) and decoction of Kulatha (Dolichos
biflorus) each respectively for 7 times. This method is said to be praiseworthy. 22
2. The Swarna Patra (Gold foils) are to be wrapped with Kalka (paste) of
Panchamrttika, Saindhava lavana and Nimbu Swarasa and then kept in Samputa and
heated with Vanya Upalas. When Samputa becomes Swangashita, the Patra (gold
foils) are to be washed with hot water and then dried.23
Forms of Swarna
Acharya Kashyapa has not specifically mentioned the form of gold to be used in
Swarna Prashana. But by the method of administration mentioned as ―rubbing on a
stone‖ it can be inferred that pure gold in metallic form should be used.

Drug Review
Other Acharya have also mentioned the usage of pure gold internally. The references
in Ayurveda about the form of gold to be used internally are as given below.
24 25 26 27
1. Churna (powder)
28
2. Patala/Mandala (leaf/foil)
29
3. Bhasma (ash)
4. Lavana (gold salt)
Dosage:
According to Acharya Sushruta and Vagbhata, the dosage of Swarna/ Swarna

Churna is as follows:
30
 1 Gunja (125mg)
 1 Harenu Matra31
Table 2.5 : Pharmacological properties of Swarna: 32,
Rasa Madhura, Kashaya33

Guna Snigdha
Virya Sheeta
Vipaka Madhura
Doshaghnata Pitta Shamaka, Tridoshapaham
Karma
On Higher On On GIT On Reproductive General Actions
mental Sensory system
functions system
Medhya Netrya Ruchya Agrya Vurshya Vishagada hara
Budhikara Agnidipaka Uttama Parama Hrud
Smrutikara Garbhasthapana Yakshmanashaka

daurbalyaharam
Sukhakara Unmadaprashamana
Deha Roganashaka
Hrudya, Rasayana34
36
Brumhana
Drug Review
Swarna Bhasma
The form of gold used in the present study was Swarna Bhasma which is the
incinerated form of gold.
35
Method of preparation of SwarnaBhasma :
The general preparation of Swarna Bhasma involves the three processes of

Shodhana, Dravana and Marana. The leaves of purified gold are taken and two times
purified murqury is added into it. The mixter is trichurated with Nimbu swarasa and
small rounded Chakrika are prepared. The shallow earthan pot was taken. In to it the
sulphar powder was spread and Chakrika are put on it, again the layer of sulphar
powder is done on it. This earthen pot was closed properly and heated with the help of
30 Aranyopala/Laghu puta. This procedure is revised for 14 times, then Swarna
bhasma get prepared.
Organoleptic characteristics:
Colour - Dark brown
Smell - Specific faint smell
Touch - Fine
Taste - Tasteless
36 37
,
Pharmacological & Therapeutic Properties of Swarna Bhasma: :
 Rasa - Madhura,
 Guna - Snigdha, Laghu
 Vipaka - Madhura
 Virya – Shita
 Doshaghanata – Tridoshashamak
 Karma -Vrushya, Ayushya, Varnya, Balya, Dipana, Shwasa Kasahara,
Aruchi, vishamajwaranashaka, Brumhana, Vajikara, Rajayakshmahara,
Ojowardhana, Pandunashana, Sarvavishapaham, Garharam, Granhnanyadi
doshanashanam etc.
38
Dosage : Swarna Bhasma - 1/8 to 1/4 Ratti. (15 – 30 mg)
Drug Review
Pharmacological Studies:
 Antioxidant Activity-
The antioxidant and restorative effects of Swarna bhasma in rats have recently
been demonstrated39. The study was done under ischemia, which was induced by
bilateral carotid occlusion under phenobarbitone anesthesia. A number of antioxidant
enzymes and lipid arthritis. Auranofin and gold sodium thiomalate (GST) are the
peroxidation were studied. Swarna bhasma (25 mg/kg) had a restorative
effect, significantly restoring antioxidant levels in ischemic animals. Biochemical
findings supported the histological examination of the brain. The free radical
scavenging and antioxidant effects of Swarna bhasma have also been investigated
recently by several groups. Two antioxidant enzymes — superoxide dismutase
(SOD) and catalase — were measured after oxidative insult with acetic acid in both
Swarna bhasma-treated mice as well as control serum and liver homogenate of mice.
Chronic administration of Swarna bhasma had no toxic effects as assessed by liver
function test enzymes and histological investigations.
 Analgesic Activity-
Analgesic activity of Swarna Bhasma was reported in one study involving

mice. A Unani calcined gold preparation, kushta tilan kalan (KTK), was also
used in this study along with the widely used gold drug auranofin. Swarna
bhasma at 12 to 50 mg/kg body weight by oral route showed analgesic activity
against chemical, thermal, electrical, and mechanical stimuli. Whereas the
analgesic effect of Swarna Bhasma could be blocked by the treatment of
nolaxone, such antagonism was not possible in the case of auranofin. The
study suggests involvement of opiodergenic mechanism in the observed
40
analgesic activity of Swarna Bhasma
Curative effects on many diseases are mentioned as below.
 Vishamajwara & Tridoshajwara,

 Antrashosha, Atisara, Grahani and Pandu
 Prakhseenamedhasmrutipatava

Drug Review
 Unmada, Vaichitya, Yoshapasmara and Chittodvega.

 Bhrama, Glani and Murcha
 Asthikshata, Asthishotha, Janghasthivedana and Asthishosha,
 Hrutvepana
 Kasa and Shwasa
 Phiranga, Mushkashotha, Mushka-Mamsavruddhi etc.
Due all the above said properties Swarna Bhasma is also indicated especially in
young and children.
The chemical constituents of a standard Swarna Bhasma are listed below.41
Table 2.6: Chemical constituents of standard Swarna Bhasma
Sl.no. Constituents Standard values in % w/w

1. Free sulphur Not less than 1.43 and not more than 6.39
2. Sulphur Not more than 3.33
3. Calcium as Ca Not more than 1.625
4. Sodium as Na Not more than 0.922
5. Potassium as K Not more than 0.370
6. Sulphate Not more than 3.00
7. Copper Not more than 17.2
8. Iron oxide (ferric) Not more than 85.0
9. Iron oxide (ferrous) Not more than 5.7
10. Iron Not less than 36.0 and not more than 51.96
11. Phosphate as PO4 Not more than 1.101
12. Silica Not more than 3.8
13. Acid in soluble Not more than 11.93
The ash value of standard Swarna Bhasma should be between 92.10 and no more than
98.20% w/w and its acid-insoluble ash value should be between 21.20 and 31.18%
42
w/w.
Dosage:
Acharya Kashyapa has not mentioned the dosage for Swarna Prashana in
specific. But he has given general dosage of children according to age in the same

Drug Review
context from birth. The same can be followed to fix the dosage of Swarna
Prashana. A few other available references from various texts are as listed below.
 1/4th – 1/8thRatti (15-30mg) Swarna Bhasma43

 2 Gunja (250mg)44
45
 1/32Ratti(3.9mg)
 15.5 to 62.5 mg of Swarna Bhasma46
Review on experimental study of the drug:
1. Swarna (Gold):
There are a number of pharmacological and clinical studies carried out on gold the
outcome of which are cited below.
Findings in newborn:
In a study trace elements including gold were measured in human placenta

and newborn liver at birth.47
A number of trace elements including gold were measured in the hair of

newborn infants. It was observed that in the first three months of life zinc, copper and
gold contents showed a considerable increase to multiple levels of the birth values,
followed by a decrease. Gold, although classified as a non- essential trace element, it
behaved in the hair of infants just like the physiologically important essential trace
elements zinc and copper. 48
In a pharmco-clinical study on neonates Madhu-Ghrita-Swarna

- Vacha combination showed a significant effect of humoral anti-body formation and
it acted on immunological system which was evident by triggering the response of
immunological system by a rise in the total proteins and serum IgG levels. 49
Effect on immune system:
Pharmacological studies showed specific and nonspecific immune

responses which were modified in a positive manner in Swarna Bhasma treated mice.
In the study, the dose of Swarna Bhasma was in the range of 12.5 to 50 mg/kg body
weight.50

Drug Review
MADHU (Honey)
51 52
Gana- Charaka- Jangam dravya , Vamanopaga dravyani , Shonitasthapana
dravya53, Ikshu varga54
Sushruta- Madhu varga55.
Astang hridaya -Madhu varga56, Madhurskandha57,Niruhapayogi dravya58.
Zoological name- Honey is a sweet food made by some insects using nectar from
flowers,produced by honey bees (the genus Apis melifera).
Synonyms: Kshaudram, Makshikam, Kusumasavam, Pushpasavam,

Pavitram, Pushparasam, Madhvikam, Saradham, Makshikavantam, Bhrungavantam59
Charaka Samhita included Madhu in Jangama dravya,60 Vamanopaga

and
Shonitsthapana dravya.61 Madhu has also been included in Ikshuvarga.62
Sushruta samhita mentions it in Madhuvarga.63Ashtanga hridaya included Madhu in

64 65
3 groups namely Madhuvarga Madhuraskandha and Niruhapyogidravya66
Rasa panchaka67-
 Rasa – Madhura, Kashaya.

68
 Guna – Ruksha, Shita, Guru (cha.) , Laghu (sus)69, Picchila,
Sukshmarganusari, Yogavahi.
 Virya – Shita
 Vipaka –Madhuar.
 Doshaghanata – Vatakaraka, Pitta-rakta-kapha shamaka.
(cha.), Tridoshashamak (Sus.)
 Karma – Dipana, Varnya, Swarya, Lekhanam, Sandhanam, Shodhanam,
Ropanam, Chedanam, Sangrahi, Chakshushaya, Prasadanam.
Rogaghnata – Trishna, Visha, Hikka, Raktapitta, Prameha, Kustha, Krimi,

Chhardi, Shwasa, Kasa, Atisara, Vrana sadhankara, Vajikara.

Drug Review
Types-According to Charaka-55 4 types.
 Makshika- Shrestha, Taila varna

 Bhramara- Guru, Shweta varna
 Kshaudra- Kapila varna
 Pauktika- Ghrita varna
According to Sushruta-56 8 types.
 Pauktika – made by poisonous flowers, Ruksha-Ushana, Vidahi,

Madajanan.
 Bhramar – Guru, Picchila, Madhur.
 Kshaudra – Shita, Laghu, Lekhana.
 Makshik – Laghutara, Ruksha, Shrestha.
 Chhatra – Madhura, Guru, Shita, Raktapitta-Shwetakustha-Prameha-
Kriminashak.
 Arrdhaya – Kashaya-Katu, Vatakar, Netrya, Balya.
 Auddalaka – Ruchikara, Swarya, Kustha-Vishanashaka.
 Dal - Kashaya-Katu-Amla, Ushna, Pittakara, Charrdi-Prameha
shamana
Composition:
Honey primarily contains sugar and water. Sugar content is about 95–99% of
honey dry matter. Majority of these are simple sugars, fructose (38.2%) and glucose
(31.3%), which represents 85–95% of total sugars. These are simple sugars, 6-
carbon sugars that are readily absorbed by the body. 70 Other sugars include
disaccharides such as maltose, sucrose, and isomaltose. Few oligosaccharides are also
present. Water is the second most important component of honey. Organic acids
constitute 0.57% of honey
and include gluconic acid which is a by-product of enzymatic digestion of glucose.

Minerals are present in honey in very small quantities (0.17%) with potassium as the
most abundant. Others are calcium, copper, iron, manganese, and phosphorus.
Nitrogenous compounds among which the enzymes originate from salivary
secretion of the worker honeybees are also present. They have important role in the
Drug Review
formation of honey. The main enzymes in honey are invertase (saccharase), diastase
(amylase) and glucose oxidase. Vitamins C, B (thiamine) and B2 complex like
71
riboflavin, nicotinic acid and B6 panthothenic acid are also found.
Nutritional value for 100 g honey, (roughly 5 tbsp) is shown in the following table:
72
Table 2.7: Nutritional value of Honey per 100 g (3.5 oz)
Sl.no. Component Value per 100g of honey

1. Energy 1,272 kJ (304 kcal)
2. Carbohydrates 82.4 g
3. Sugars 82.12 g
4. Dietary fibre 0.2 g
5. Fat 0g
6. Protein 0.3 g
7. Water 17.10 g
Vitamins
8. Riboflavin (Vit. B2) 0.038 mg (3%)
9. Niacin (Vit. B3) 0.121 mg (1%)
10. Pantothenic acid (B5) 0.068 mg (1%)
11. Vitamin B6 0.024 mg (2%)
12. Folate (Vit. B9) 2 μg (1%)
13. Vitamin C 0.5 mg (1%)
Minerals
14. Potassium 52 mg (1%)
15. Iron 0.42 mg (3%)
16. Magnesium 2 mg (1%)
17. Phosphorus 4 mg (1%)
18. Calcium 6 mg (1%)
19 Sodium 4 mg (0%)
20 Zinc 0.22 mg (2%)

Drug Review
Research evidences on Honey:

Pure honey has been shown to be bactericidal to many pathogenic microorganisms
including Salmonella spp, Shigella spp; other enteropthogens like Escherichia coli,
73,74
Vibrio cholerae and other Gram negative and Gram positive organisms.

An antifungal action of honey has been observed for some yeasts and species of
Aspergillus and Penicillium, as well as all the common dermatophytes.75

The current prevalence of antibiotic-resistant microbial species has led to a re-
evaluation of the therapeutic use of ancient remedies, including honey.76 Honey has
been found in some instances by some workers to possess antibacterial activities
77,78
where antibiotics were ineffective.

Researches of a study discovered that the antimicrobial activity of honey was more
with Pseudomonas and Acinetobacter spp, both with resistance to some antibiotics
79
like Gentamicin, Ceftriazone, Amikacin and Tobramicin than other bacteria tested.

Aristotle (384–322 BC), when discussing different honeys, referred to pale honey as
80
being ―good as a salve for sore eyes and wounds‖.

Mast cell de-granulating peptide (MCDP), a peptide which is a basic 22 amino acid
residue component of honey bee venom with striking immunological and
pharmacological activities. MCDP is a potent anti- inflammatory agent, but at low
concentration it is strong mediator of mast cell degranulation and histamine release.

Honey has been reported to have an inhibitory effect to around 60 species of bacteria
including aerobes and anaerobes, gram-positives and gram-negatives.81

The presence of Nerve growth factor (NGF) was detected in snake, bee and
scorpion venoms.82

Mast cell de-granulating peptide (MCDP), a peptide which is a basic 22 amino acid
residue component of honey bee venom with striking immunological and
pharmacological activities. MCDP is a potent anti- inflammatory agent, but at low
concentration it is strong mediator of mast cell degranulation and histamine release.83
Drug Review
GOGHRITA:-
 Gana-
Charaka- Gorasa varga84.
Sushruta.- Ghita varga85.
Astanga Hridaya – Kshira varga86
 Rasa panchaka87-
 Rasa – Madhura.
 Guna – Snigdha, Saumya, Mridu, Guru.
 Virya – Shita.
 Vipaka – Madhura.
 Doshaghnata- Vatapitta shamaka, kaphavriddhikara
 Karma- Sarvasnehattamam, Sahasraviryam, Sahasrakarmakritam,
samskaranuvartanam, Medhya, Swarya, Dipana,Oja-Teja-Bala-Ayushya vriddhikara,
Vrishya, Vayasthapana, Chakshushya,Rakshoghna.
 Rogaghnata- Visha, Unmada, Apasmara, Shosha, Shool, Jwara, Kshatakshina,
Visarpa, Shastra- agnihata. Anahahara.
Chemical constituents-
Fatty acids, Phospholipids, Sterols, Sterols esters, Fat soluble Vit. (Vit. A, D, K)
Hydrocarbons, Carotenoids, Casein, Traces of iron Phosphorus, copper, Traces of iron
Phosphorus, copper, β carotene.
Chemical composition of Cow's ghee-88
 Triglycerides : 97.98%
 Diglycerides : 0.25 -1.5%
 Monoglycerides : 0.16 - 0.038%
 Ketoacid glycerides : 0.015 - 0.018%
 Glyceryl esters : 0.011 - 0.015%

Drug Review
 Free fatty acid : 0.1 - 0.44%
 Phospholipids: 0.2 -1%
 Sterols : 0.22 - 0.4%
Fat soluble vitamins:
 Vit. A : 2500 I.U. /100 gm
 Vit. D : 8.5x 10.7 gm/100 gm
 Vit. E : 24 x10.3gm/100gm
 Vit.K : 1.0 x 10.4 gm /100 gm
Pharmacological activity- 89,90,91
Its digestibility coefficient or rate of absorption is 96% which is highest of

all oils and fat. It contains beta-carotene and Vit. E, which are antioxidants themselves.
It contains 8% lower saturated fatty acids which make it easily digestible. Cholesterol
and saturated fatty acid are main components of cell membrane and they provide
stiffness to cell wall and make the cell waterproof respectively. Cholesterol also
provides the basic material for the production of sex hormone and anti stress hormones.
Saturated fats boosts immune system, protects against pathogens, provides energy to the
heart and is vital to the function of kidneys and the lungs.
Research evidences on Ghee (Ghrita):
o Cow’s ghee exhibits anticollestric activity, memory enhancing activity,

immunostimulant activity and promotes healing of wounds92
o Dietary cow ghee compared to soybean oil down regulates the enzyme activities
responsible for carcinogen activation in liver and up regulates carcinogen
93
detoxification activities in liver and mammary tissues.
o The ritual worship being done in Hindus has the similar disinfecting properties.
94
Studies have shown that lightning the lamp with cow's Ghee has anti-viral property .
o Some of the fatty acids in ghee include palmitic acid, myristic acid, and lauric acid
which are important for stabilization processes in the body including stabilizing
proteins used in the immune system and to fight tumors. When researchers looked at
Drug Review
the fatty acid composition of the phopholipids in the T-cells (white blood cells), from
both young and old donors, they found that a loss of saturated fatty acids in the
lymphocytes was responsible for age-related declines in white blood cell function.
They found that they could correct cellular deficiencies in palmitic acid and myristic
acid by adding these saturated fatty acids. 95
o Cow’s milk as a means to transfer immunogens or antigens is being used by
rendering hyper-immune response by administration of an apporopriate agent. In this
hyper-immune state, the antigens find their way into the milk of the cow, which
when administered to humans, especially children; render the immune to the
particular disease. Cow’s ghee also has been seen to stimulate immune processes in
experimental animals. This propert y has i m p o r t a n t potential in treatment of
96
diseases like AIDS and Cancer.
Preparation of the Trial and Adjuvant drugs
Both Swarna Prashana Yoga and the adjuvant drug used in the present study were
prepared in the laboratory of Dept. of Kaumarbhritya, IPGT & RA by the scholar. The
method of preparation of both the drugs is given below:-
Source of drug:
Authentically prepared Swarna Bhasma was procured from Dept. of Rasashastra and
Bhaishajya Kalpana, IPGT & RA, Jamnagar. Ghee was purchased from the standard
local market which was of AGMARK authentication. Honey was procured from IPD of
Kaumarbhritya, IPGT & RA Jamnagar which was of ―A‖ grade.
Dosage form: Drops
Method of preparation:
Both Swarna Prashana Yoga and adjuvant drug were prepared in bulk, in 2 different
batches for better storage and handling of the drug.The preparation was done with utmost
care to avoid any sort of contamination by using sterile vessels and gloved hands. Cap
and mask were worn during the entire preparation period. To ensure further safety, glass

Drug Review
bottles used for storage were sterilised.
Figure 2.1:- showing Swarnaprashana Yoga Figure 2.2:-Showing Madhu-Ghrita Yoga
In each batch Swarna Prashana Yoga was prepared with 315 mg of Swarna Bhasma,
11gm of ghee and 127gm honey which were triturated well for about 8 hours in Akika
Khalva Yantra (Mortar and pestle made of semi-precious stone, Akika) for better mixture
and consistency of the formulation. Adjuvant drug of each batch contained 11g ghee and
127g honey which was triturated in the same manner as that of Swarna Prashana Yoga.
This specific proportion of the ingredients was adopted after a few trial and error of
preparations so as to fix the dosage form as drops which would be easier to administer in
infants.
Method of administration of drug:
For administration of the drug infants dropper bottles were used, 5 drops daily morning.
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Analytical Study
ANALYTICAL STUDY
Ayurveda can be defined as a medical science which helps the human body to
keep it healthy which providing cures through indigenous plants, animal products and
minerals for ailments. The Ayurvedic classics, compilations and other literatures
contain references to utilization of large number of medicinal plants for therapeutic
purpose. Ayurveda has quoted that as the Prakriti varies from person to person,
similarly every drug has its own physical and chemical characteristics which help to
separate it from other closely related drug.
Physical evaluation is a broad term under which various parameters of
analytical study ensures not only chemical constituents but also tells about standards
of the preparation and indirectly gives suggestion for further advancement. The word
standardization implies to the application of suitable and processes by which optimum
conditions are ensured for obtaining predictable results and product which confirm to
certain set of standards in quality, purity, stability, safety and shelf life etc.1
Thus to ensure a good quality analysis of the formulations used, the present
analytical study was undertaken so as to evaluate and compare the formulations with
the available parameters in different steps as follows:-
1. Analysis of organoleptic characters
2. Physio-chemical analysis
3. Microbiological analysis
Aims and Objectives:

1 To analyse the quality of raw materials used to prepare both test and adjuvant
drugs with respect to their microbial contamination.
2 To analyse the finished products with respect to their physico-
chemicalproperties.
3 To analyse stability of the finished products with respect to microbial
contamination so as to ensure the quality and safety for internal administration.
Material and Methods:

1. Samples of Ghee and Honey
2. Samples of Test (Swarna Prashana) and Adjuvant drug

Analytical Study
Methods
The parameters which were followed for the study are as follows:
A. Microbiological analysis
B. Physico chemical analysis
C. Analysis of Organoleptic characters
Organoleptic Characters
The raw drugs for preparation of the formulations were honey and ghee which
were having dark brown and yellowish colour respectively. Trituration was carried
out for about 8 hours to prepare a homogenous mixture. In adjuvant drug the
colour of mixture of honey and ghee was retained as yellowish brown. In the trial
drug, as the Swarna Bhasma was added during trituration little by little, its colour
started changing from yellowish brown to dark brown. Rest of the organoleptic
parameters remained same for both the formulations.
Table 3.1 : Organoleptic characters of Trial and Adjuvant drugs
Parameters
Samples Appearance Taste Smell Consistency Colour
Trial drug Viscous Sweet Characteristic Thicker soft Dark

(Rupa) (Rasa) (Gandha) (Sparsa) (Varna)
Adjuvant Viscous Sweet Characteristic Thick soft Yellowish
liquid Brown
drug liquid brown
Physico –Chemical Analysis
The trial and adjuvant drugs were analyzed for different physico-chemical
parameters by routine methods used at the Pharmaceutical Chemistry Laboratory,
IPGT & RA, Jamnagar viz. loss on drying, sugar estimation (reducing, non-
reducing and total sugar), water and methanol-soluble extractive values. The
parameters analyzed were limited due to the practical difficulties in the analysis as
both the test and adjuvant drugs were contained water and fat soluble ingredients in
combination. Suitable parameters were studied in order to develop a standard for the
reproducibility of Swarna Prashana of the same quality thereby ensuring uniform
therapeutic efficacy.

Analytical Study
Aims and Objectives:
To assess the physicochemical parameters of the test (Swarna Prashana) and

adjuvant drugs.
Materials & Methods:
Sample1- Trial drug (Swarna Prashana)
Sample 2- Adjuvant drug
The methods followed were as follows.
1. Loss on Drying2
The value of loss on drying determines the amount of water and volatile matter in
a sample when the sample is dried under specified conditions. For determination of
the loss on drying, 2 gm. of the sample was taken in a previously dried and weighed
dish. It was dried initially on a water bath and finally in an oven at 110°C
temperature till constant weight was obtained. From the weights noted, the loss
on drying of the sample was calculated and expressed as percentage w/w.
2. Water Soluble Extractive:3
5 gram of the sample was weighed accurately. 100 ml of distilled water was added
to it and kept covered overnight. Next day, it was filtered. 20 ml of the filtrate was
accurately measured with a pipette and transferred to the already weighed
evaporating dish. The evaporating dish was placed on a water bath for evaporation of
the water. After evaporation of the water it was dried in an oven, allowed cooling
and weighed immediately. From the weight of the residue obtained, the percentage of
water soluble extractive was calculated and expressed as % w/w.
3. Alcohol Soluble Extractive:4
2.5 gm test drug sample was weighed accurately. 50 ml methanol was added to it and
kept covered overnight. Remaining procedure was same as water soluble extract
method. From the weight of the residue obtained, the percentage of alcohol soluble
extractive was calculated and expressed as % w/w.

Analytical Study
4. Sugar content (Total, Reducing & Non-reducing):5
This includes estimation of total, reducing and non-reducing sugars.
Preparation of solution for analysis:
5 gm drug sample was taken in a glass beaker and 100 ml distilled water was
added and stirred to make solution, to which the clarifying agent, 10% lead acetate
solution, was added and warmed for about 3-5 minutes to get the precipitate. Solution
was filtered through brown paper. To the filtrate sodium oxalate was added to
dissolve excessive lead acetate and to get a clear solution. This solution was
filtered through the filter bed made up of glass wool, cotton and Whattman no. 1 filter
paper to get a clear solution, washing was given by distilled water and the volume
was made up to 250 ml.
A. Total sugar:
25 ml of the clarified solution was taken; to it 5 ml of 6N HCl was added and

heated on water bath at 67-71°C. Then it was treated with concentrated NaOH by
using phenolphthalein as indicator till pink colour appeared.
Volume was made up to 100 ml. For the determination of total sugar, 20 ml. of this
solution was taken and the remaining procedure is the same as that of reducing sugar.
Percentage of total sugar was calculated from Hammond table.
B. Reducing sugar:
Into 20 ml. of above solution, 25 ml. each of Fehling’s A and Fehling’s B

solutions were added, boiled for three minutes and filtered through filter bed (glass
wool, cotton and Whattman no. 1 filter paper). Repeated washing was given by hot
distilled water till clear, colourless filtrate was obtained. Precipitate of cuprous oxide
(residue) was then taken with acid ferric solution to dissolve the precipitate
completely in it. This solution was titrated against KMnO4 using orthophenanthrolin
as indicator. At the end point, the brownish solution changes to green. From the
amount of KMnO4 solution required, the amount of copper was calculated. Then
percentage of sugar content was determined from Hammond table.

Analytical Study
C. Non-reducing sugar:
The non-reducing sugar content was obtained by subtracting reducing sugar from
total sugar.
Non reducing sugar = Total sugar – Reducing sugar.
the results of the study are shown in the following table.
Table 3.2 : Physico-chemical parameters of Trial and Adjuvant drugs:
Results
Sl.no Name of Test
Sample 1 Sample 2
1. Loss on Drying 13.60 % w/w 11.26 % w/w
2. Water Soluble Extract 71.16 % w/w 82.18 % w/w
3. Methanol Soluble Extract 80.14 % w/w 79.88 % w/w
Qualitative test
1. Total Sugar 54.64 % 55.97%
2. Reducing Sugar 48.04 % 45.78

%
3. Non- Reducing Sugar 6.60 % 10.19
%
5. Microbiological analysis:
Stability of a pharmaceutical product is the capability of a particular

formulation in a specific container or closure system, to remain within its physical,
chemical, microbiological, therapeutic and toxicological specifications at a
defined storage condition.6 As Swarnaprashana is administered in children even
from new born period, it was necessary to prepare the formulation in a better
dosage form which is also free from any microbial and fungal contamination.
Thus the present study was designed to study the stability of Swarna Prashana
Yoga with respect to microbial contamination in the four selected samples of each
groups prepared and stored in two different climatic conditions and temperature.

Analytical Study
The raw drugs, ghee and honey were also subjected to similar study before
preparation of the samples.
Aims
a) To study microbial contamination in Ghee and Honey before preparation of the

samples.
b) To study microbial contamination in the prepared samples of
Swarna Prashana and adjuvant drug in two different climatic and
temperature conditions.
Materials:
1) Sample of Ghee- G
2) Sample of Honey- H
3) Samples of Swarna Prashana Yoga (Group C) - sample C1, C3 (stored at room
temperature) and C2, C4 (stored at refrigerator)
4) Samples of adjuvant drug (Group B) – sample B1, B3 (stored at room
temperature) and B2, B4 (stored at refrigerator)
Methods:
Wet mount, Fungal Culture, Gram stain and Aerobic Culture tests were used
to study microbial and fungus contamination in the samples. The samples G and H
were subjected to tests only once, before preparation of the samples. Two groups
named group B (Madhu-Ghrita) and group C (Swarnaprashana Yoga) prepared in 2
batches in the month of March 2015 and September 2015, stored under different
climatic and temperature conditions were studied at regular intervals in different
climatic seasons for a period of 11 months and 5 months respectively to analyze
mycological findings and presence of microorganisms in prepared formulation.The
study was conducted at Microbiology laboratory, IPGT &RA, Jamnagar.
 Preparation time:
Group B and group C were prepared in two different batches. 1st batch (group
B and group C) was prepared and preserved during the months of March 2015 to
Jan 2016 and 2nd batch ( group B and group C) were prepared and preserved during
the months of September 2015 to January, 2016. The preparation was done with

Analytical Study
utmost care to avoid any sort of contamination by using sterile vessels and gloved
hands. Cap and mask were worn during the entire preparation period. To ensure
further safety, glass bottles for storage were sterilized by rinsing with 10% sodium
hypochlorite (chemical sterilization method) and then kept in hot air oven (physical
sterilization method).
Storage:
The 1st batch sample was stored in two parts; one part at room temperature
(sample B1 and sample C1) in a dry and dark place to avoid exposure to direct
sunlight and wind and the other in refrigerator (sample B2 and C2).
The 2nd batch sample was also stored in two parts; one part at room
temperature (sample B3 and sample C3) and the other in refrigerator (sample B4 and
sample C4). No preservatives were added to the samples for storage.
All the eight samples were subjected to stability study with respect to
microbial and fungal contamination at regular intervals in different season for a
period of 11 months (1st batch) and 5 months (2nd batch) the details of which are cited
below.
Microbial profile:
Microbial contamination was assessed by two methods to check any mycological

findings and bacteriological findings. The details of the procedures followed are given
below.
1. Wet mount test and Fungal culture:
Aim: To rule out any mycological findings.
Specimen: Group B (Sample B1, B2, B3, B4) and Group C (sample
C1,C2,C3,C4)
Procedure:
Smear examination: A drop of selected samples were taken on grease free glass slides
+ 1 0 % K O H and covered with clean cover slips for microscopic examination.

Analytical Study
Fungal culture method:

Respected materials collected with sterile cotton swab for inoculation purpose on
selected fungal culture media (i.e. an artificial preparation).
Name of media : Sabouraud Dextrose Agar Base (SDA),
Modified (Dextrose Agar Base, Emmons)
Company : HIMEDIA Laboratories Pvt Ltd.
Required time duration : 05 to 07 days
Required temperature : 37 ºC
Use of media : for selective cultivation of pathogenic fungi.
. Figure 3.1: Fungal culture media
2. Gram stain test:

Gram staining is a differential staining technique that differentiates bacteria
into two groups: gram-positive and gram-negative. The procedure is based on the
ability of microorganisms to retain colour of the stains used during the
gram stain procedure. Gram-negative bacteria are decolourized by any organic
solvent (acetone or Gram’s decolourizer) while Gram-positive bacteria are not
decolourized as primary dye retained by the cell and bacteria will remain as
purple. After decolourization step, a counter stain effect found on Gram negative
bacteria and bacteria will remain pink. The Gram stain procedure enables bacteria
to retain colour of the stains, based on the differences in the chemical and physical
properties of the cell wall7

Analytical Study
Aim: To rule out any bacteriological findings.

Specimen: Group B (Sample B1,B2,B3,B4) and Group C (sample
C1,C2,C3,C4)
Procedure:
The smear was covered with crystal violet and allowed to remain for mentioned time
as per kit procedure. Then the stain was washed off, using a wash bottle of distilled
water/tap water. Excess water was drained off.
In second step the smear was covered with Gram’s iodine solution and allowed to
remain for mentioned time as per kit procedure. Gram’s iodine was later poured off
and the smear was washed off, using a wash bottle of distilled water/tap water.
In third step the smear was flooded with Gram’s decolourizer i.e. acetone for
mentioned time as per kit procedure. The excess acetone was removed by rinsing the
slide with distilled water/tap water.
In fourth step the smear was covered with saffranin for mentioned time as per kit
procedure followed by distilled water/tap water wash and allowed to air dry. The
slide was examined under oil immersion.
Figure 3.2: Stained smear ready for examination
Aerobic culture method:
Respected materials collected with sterile cotton swab for inoculation purpose on
selected aerobic culture media (i.e. an artificial preparation)

Analytical Study
Name of media : Mac Conkey Agar (MA) and Coulmbia Blood agar
(BA)
Company : HIMEDIA Laboratories Pvt Ltd.
Required time duration : 24 to 48 hours
Required temperature : 37 ºC
Use of media : for selective cultivation of pathogenic bacteria.
Figure 3.3: Aerobic culture media (MA) Figure 3.4: Aerobic culture media (BA)
OBSERVATIONS:
Following findings were observed at the end of the study. Samples G and H did not
show presence of fungal filaments and microorganisms which was tested before
preparation of the samples. The tables 1, 2, show the observations of 1st batch
samples i.e. B1, C1 and B2, C2 respectively while tables 3, 4, show the observations
of 2nd batch samples i.e. B3, C3 and B4, C4 respectively during the tests at regular
intervals in different climatic seasons for a period of 11 months (1st batch) and 5
months (2nd batch).

Analytical Study
Table 3.3- Observation of Sample B1 and C1 preserved in room temperature-
SI No. Months of Observation of sample B1 and sample C1

investigations
After Gram’s Stain Aerobic Wet mount/ Fungal
preparation culture 10% KOH culture
of the sample Preparation
1. May (2015) Microorganisms No Fungal No Fungal
Not Seen organisms filaments not Pathogen
isolated seen. Isolated
2. Aug (2015) Microorganisms No Fungal No Fungal
isolated seen Isolated
3. Nov (2015) Microorganisms No Fungal No Fungal
4. Jan (2016) Microorganisms No Fungal No Fungal
Table 3.4: Observation of Sample B2 and C2 preserved in refrigerator-

investigations
After Gram’s Stain Aerobic Wet mount/ Fungal
1. May (2015) Microorganisms No Fungal No Fungal
isolated seen. Isolated
2. Aug (2015) Microorganisms No Fungal No Fungal
3. Nov (2015) Microorganisms No Fungal No Fungal
Sample B1, C1 (Table 1) and sample B2, C2 (Table 2) preserved at room
temperature and refrigerator respectively during the month of March 2015 to Jan
2016, did not show presence of any mycological or bacteriological findings at the
end of 11 months after preparation of the samples.

Analytical Study
2nd Batch-
Table 3.5: Observation of sample B3 and C3 preserved in room temperature-

investigations
After Gram Stain Aerobic Wet mount/ Fungal
1. Oct (2015) Microorganisms No Fungal No Fungal
Not seen organisms filament not pathogen
isolated seen isolated
2. Dec (2015) Microorganisms No Fungal No Fungal
Not seen organisms filament not Pathogen
Table 3.6: Observation of sample B4 and C4 preserved in refrigerator-

investigations
After Gram Stain Aerobic Wet mount/ Fungal
1. Oct (2015) Microorganisms No Fungal No Fungal
Not seen organisms filament not pathogen
2. Dec (2015) Microorganisms No Fungal No Fungal
Sample B3, C3 (Table 3) and sample B4, C4 (Table 4) preserved at room
temperature and refrigerator respectively during the month of September 2015 to
Jan 2016, did not show presence of any mycological or bacteriological findings at the
end of 5 months after preparation of the samples.
All the samples of 1st and 2nd batch show negative finding of bacterial as well as
mycological contamination.

Analytical Study
References-
1
www satandard .com au pharmaceutical product retrieved on 19.03.16
2
Ayurvedic Pharmacopoeia of India PDF-1, Govt. of India, Ministry of
health and family welfare, Delhi, 2007, vol.-5, appendix-2.2.9. p. 214
3
4
5
Anonymus, Pharmacopoeial standards for Ayurvedic formulation, CCRAS,
Ministry of health and family welfare, Delhi
6
Linda Ed Felton, Remington: Essentials of Pharmaceutics, Pharmaceutical Press,
UK,2013, p. 37.
7
Alfred E Brown, Benson: Microbiological Applications, The McGraw−Hill
Companies, USA, 2001, p. 64

Clinical Study
CLINICAL STUDY
Introduction:
Ayurveda, the ancient science of medicine is based on facts, which were experimented
several times by our aapta acharyas. But, in present era, strong necessity is noticed to
reprove, assess, modify and modulate those old concepts for their wider applicability
and acceptability by latest quantitative parameters, to absolute satisfaction of
everyone, including modern man, with a view to place Ayurveda at global level. It is
the era of Evidence Based Medicine (EBM) which has its core in blending the best
available evidence, with clinical judgment and patient’s preferences for optimal
management of illness. The concept of Swarna Prashana is an experience based
practice documented in the field of child healthcare since centuries. At this juncture, it
becomes essential to revalidate the hypothesis and observations according to the
norms and practices of present day clinical research.
Clinical research has been accepted since years in the classics and the importance of
clinical practice is mentioned by Acharya Vagbhata1, by following the fundamental
concepts of evidence based medical practice, the hypothesis is generated in the
conceptual part and accordingly the selected drugs are subjected to clinical evaluation
in order to establish the hypothesis.
The description of Swarnaprashana in detail is given in Kashyap Samhita.
According to Acharya Kashyapa, Swarnaprashana helps to increase the immunity of
newborn and protect the newborn against the infections if administered for a period of
1 month.2 Hence this study may open a new vista in the field of Vyadhikshamatva
(Vyadhibhirna Cha Drushyate). The Bala or Ojas is the basis of Vyadhikshamatva or
immunity. Vyadhikshamatva is interpreted as Vyadhibala Virodhitva – antagonistic to the
strength and virulence of disease, and Vyadhiyutpadaka Pratibandhakatva – the capacity
to inhibit or contain or neutralize or resist or overcome disease causing agents which may
be any harmful foreign materials like microbes,, viruses etc. Hence to explore an
innovative outlook in the field of Kaumarabhritya with respect to Vyadhikshamatva
in neonates, the present study was undertaken to clinically evaluate Swarna Prashana
in neonates with respect to its Immunomodulatory activity.

Clinical Study
AIMS & OBJECTIVES:

 To assess the efficacy of Swarna Prashana in neonates with respect to its,
dose, safety and efficacy with special reference to immunomodulation.
MATERIAL & METHODS:

The Clinical study was started after the approval of Institutional ethics committee
[No. PGT/7-A/Ethics/2014-2015/1538] and the Research work has been registered in
Clinical Trial Registry of India (CTRI) - CTRI/2015/11/006337-Trial registered
retrospectively.
SELECTION OF NEONATES –
Full term healthy neonates delivered at I.P.D of S.R.P.T, IPGT & RA hospital
and those are registered in I.P.D of K.B., I.P.G.T & R.A Jamnagar were selected for
clinical study.
Inclusion criteria-
1. Full term newborn. (Gestational age between 37-42 wks)

2. Birth weight > 2.5kg.
Exclusion criteria-
1. Preterm child.(Gestational age<37 wks)
2. Post term child. (gestational age>42 wks)
3. Birth weight <2.5kg.
4. Birth asphyxia.
5. Infectious diseases.
6. Congenital anomalies.
7. Hereditary diseases
METHOD OF RESEARCH:
Study design:- A Simple Random Sampling method was followed.
The subjects included in the clinical trial were divided into three groups namely-
Group A- Distilled water-Control group

Group B – Madhu –Ghrita (Unequal quantity) –Adjuvant group
Group C- Swarna Prashana [ Swarnabhasma with Madhu –Ghrita (Unequal -
quantity) ] -Trial group

Clinical Study
Dose: As both ghee and honey were adjuvant drugs, only dosage of Swarna bhasma
was fixed according to Clarke’s Rule3 which is given as below:
Infant dose= Weight in Kg X Adult dose / 70
The adult dose of Swarna bhasma was taken as 20 mg by following the

reference of Rasatarangini.4 The selected dose of Swarna bhasma was used to
prepare Swarna Prashana Yoga in which Swarna bhasma was mixed with specific
quantities of ghee and honey, the details of which are explained in the chapter of drug
review.
Dosage form: Drops
Aushadhakala: Five drops once a day in the morning followed by feeding.
Duration of the study: Duration of the study in all the groups was 6 weeks.
Follow up: Follow up was for a period of 8 weeks.
LABORATORY INVESTIGATION-
 Routine Haematological investigations- Hb%, TC, DC, TRBC & Platelet
Count. 
 Biochemical Investigations- Total protein, Serum Albumin, Serum
Globulin, A/G ratio.
a. Liver function test
b. Renal function tests
ASSESSMENT CRITERIA :
Clinical response to medication was assessed based upon subjective and objective
Parameters namely:-
1. The changes observed in the values of haematological and biochemical tests
before and after treatment.
2. Assessing the pattern of growth and development with Anthropometry.
3. Frequency of diseases of child / attack of common illness and response to
treatment are observed.

Clinical Study
OBSERVATIONS AND RESULTS-
The observations of Clinical study described below with the help of tables:
Table No.4.1 – Distribution of Neonates in different groups
No. of Neonates
Group A Group B Group C Total
Registered 20 19 19 58
Completed 15 17 16 48
Discontinued 05 02 03 10
Total 58 neonates registered in the present clinical study. Out of them 48

completed the treatment and 10 discontinued. 20 neonates registered in group A out
of which 15 completed the treatment and 5 discontinued. In Group B total number
of cases registered was 19. Out of these 17 completed the treatment and 2
discontinued. In Group C total registered cases was 19, out of which 16 completed
the treatment and 3 discontinued.
Table No. 4.2- Sex wise distribution of 58 neonates
No. of Neonates
Sex %
Gr. A Gr. B Gr. C Total
Male 11 9 9 29 50
Female 9 10 10 29 50
Total 20 19 19 58 100
Out of 58 neonates, number of Male neonates represented 11, 9 and 9 in group A,

group B and in group C respectively. Total 29 (50%) male neonates enrolled in
present study. Whereas number of female neonates represented 9, 10 and 10 in group
A, group B and in group C respectively, total 29 (50%) female neonates enrolled.
Table No 4.3-: Religion wise distribution of 58 neonates
No. of Neonates
Religion %
Hindu 12 12 13 37 63.80
Muslim 8 7 6 21 36.20
Others 0 0 0 0 0
Clinical Study
Total 20 19 19 58 100
.
In the present study maximum number of neonates i.e. 63.80 % belonged to Hindu
religion whereas rest of the neonates 36.20 % belonged to Muslim religion. In group
C 13 (68.42%) neonates belonged to Hindu religion and 6 (31.58%) belonged to
Muslim religion. In Group B 12 (63.16%) and 7 (36.84%) neonates belonged to
Hindu and Muslim religion respectively. Whereas in group A, 12 (80%) and 8 (40%)
neonates belonged to Hindu and Muslim religion respectively.
Table No4. 4:-Habitat wise distribution of neonates

No. of Neonates
Habitat %
Rural 8 7 9 24 41.38
Urban 12 12 10 34 58.62
Slum 0 0 0 0 0
Total 20 19 19 58 100
The above table reveals that total 58.62 % of the neonates enrolled in the study were
from Urban habitat whereas from 41.38 % belongs to Rural habitat.
Table No 4.5 - SES wise distribution of 58 neonates
No. of Neonates
SES Gr. A Gr. B Gr. C Total %
Lower 1 0 2 3 5.17
Lower middle 5 3 4 12 20.69
Middle 14 16 13 43 74.14
Upper middle 0 0 0 0 0
Upper 0 0 0 0 0
Total 20 19 19 58 100
The cases were classified in five groups according to their economic status i.e.,
Lower class, Lower Middle class, Middle class, Upper Middle class and Upper

Clinical Study
class. It was observed that 74.14 % parents were from middle class, 20.69 % and
5.17 % belonged to lower middle class and lower class respectively. No parents
from higher income class.
Table No-4.6: Maternal education wise distribution of 58 neonates

No. of Neonates
Education Gr. A Gr. B Gr. C Total %
Illiterate 0 1 2 3 5.17
Primary 12 10 11 33 56.90
Secondary 7 6 5 18 31.04
Higher secondary 1 1 1 3 5.17
Graduate 0 1 0 1 1.72
Post graduate 0 0 0 0 0
Total 20 19 19 58 100
Mothers of maximum cases (56.90 %) were having primary education, followed by

31.04 % secondary education and 5.17 % were higher secondary educations as well as
illiteracy. Only 1.72 % graduates mothers.
Table No-4. 7 - Paternal education wise distribution of 58 neonates

No. of Neonates
Education Gr. A Gr. B Gr. C Total %
Illiterate 0 0 0 0 0
Primary 8 8 10 26 44.83
Secondary 9 9 6 24 41.38
Higher secondary 2 2 3 7 12.07
Graduate 1 0 0 1 1.72
Post graduate 0 0 0 0 0
Total 20 19 19 58 100
Fathers of maximum cases (44.83 %) were having primary education, followed by

41.38 % secondary education and 12.07 % were higher secondary educations, only
1.72 % graduates.

Clinical Study
Table 4. 8: Distribution of Neonates based on Maternal Antenatal checkup
No. of Neonates %
ANC Gr. A Gr. B Gr. C Total
Regular 17 17 17 51 87.93
Irregular 3 2 2 7 12.07
Total 20 19 19 58 100
In this study out of 58 mothers, 51 (87.93 %) mothers had regular antenatal

checkup and only 7 mothers (12.07 %) had irregular checkup during their
antenatal period.
Table No-4.9 Maternal H/O major illness during pregnancy wise distribution.
H/O Major illness No. of Neonates %
during pregnancy Gr. A Gr. B Gr. C Total
Present 0 0 0 0 0
Absent 20 19 19 58 100%
Total 20 19 19 58 100
In the Anti Natal Care (ANC) history no any maternal history of major illness found.
Table No.4.10: Medication consumed by the mother during antenatal period
No. of Neonates %
H/O medication
during pregnancy Gr. A Gr. B Gr. C Total
Ayurvedic
Medication 13 14 14 41 70.68
No medication 2 3 2 7 12.06
Consumed
medication 15 16 18 49 84.48
84.48% of the mothers consumed medications like Folic acid, Vitamins, Iron,
Calcium, Ayurvedic drugs etc. while 12.06% of the mothers did not consume
medications during antenatal period. Among 84.48% of the mothers who consumed
medications 56% were consuming Ayurvedic medications.

Clinical Study
Table No-4.11 – Maternal H/O Gravida wise distribution of 58 neonates

No. of Neonates
H/O Gravida Gr. A Gr. B Gr. C Total %
1 5 6 2 13 22.41
2 11 10 8 29 50
3 3 3 7 13 22.41
4 1 0 1 2 3.46
5 0 0 1 1 1.72
Total 20 19 19 58 100
Maximum i.e. 50 % of the mothers were second gravidae where as 22.41% mother
were Primi and third gravidae, rest were multi gravidae.
Table No- 4.12 – H/O Maternal Parity wise distribution of 58 neonates
No. of Neonates
H/O Parity Gr. A Gr. B Gr. C Total %
1 6 6 3 15 25.86
2 12 10 10 32 55.18
3 1 3 4 8 13.79
4 1 0 2 3 5.17
Total 20 19 19 58 100
Maximum i.e. 55.18 % mother were having second parity where as 25.86 % mother
were Primi.13.79 % and 5.17 % mother were having third and fourth parity
respectively.
Table No-4.13 – H/O Onset of delivery wise distribution of 58 neonates
H/O Onset of No. of Neonates
delivery Gr. A Gr. B Gr. C Total %
Spontaneous 18 17 19 54 93.10
Augmented 2 2 0 4 6.90
Total 20 19 19 58 100
Maximum ie.93.10 % had spontaneous onset of delivery, only 6.90 % had augmented
delivery.
Clinical Study
Table No4.14 – Mode of delivery wise distribution of 34 neonates

No. of Neonates
Mode of delivery Gr. A Gr. B Gr. C Total %
Normal 19 16 18 53 91.38
Vacuum 1 3 1 5 8.62
LSCS 0 0 0 0 0
Total 20 19 19 58 100
All cases i.e. 100 % babies delivered normal, out of them only 8.62% babies delivered
normal with Vacuum assested.
Table No-4.15 – Complication during delivery wise distribution of 58 neonates

No. of Neonates
Complication %
Absent 20 19 19 58 100
Present 0 0 0 0 0
Total 20 19 19 58 100
No complication was found during the delivery in any cases.
Table No-4.16 – H/O Cry after the birth wise distribution of 58 neonates
Cry soon after No. of Neonates
%
birth Gr. A Gr. B Gr. C Total
Yes 20 19 19 58 100
No 0 0 0 0 0
Total 20 19 19 58 100
Total 58 neonates i.e.100 % babies were cried soon after the birth.
Table No-4.17 – Type of cry after birth wise distribution of 58 neonates

No. of Neonates
%
Type of cry Gr. A Gr. B Gr. C Total
Vigrous 20 19 19 58 100
Feeble 0 0 0 0 0
Poor 0 0 0 0 0
Total 20 19 19 58 100

Clinical Study
100 % babies were had vigorous type of cry soon after birth.
Table No-4.18– H/O Suction after birth wise distribution of 34 neonates

No. of Neonates
Suction %
Done 0 0 0 0 0
Not required 20 19 19 58 100
Total 20 19 19 58 100
Suction was required for any neonates.
Table No-4.19 – H/O Oxygen inhalation after birth wise distribution of 58

Neonates
No. of Neonates
Oxygen %
Given 0 0 0 0 0
Not required 20 19 19 58 100
Total 20 19 19 58 100
Oxygen inhalation was not required for any neonate.
Table No-4.20 – Resuccitation given after birth wise distribution of 58 neonates

No. of Neonates
Resuccitation %
Given 0 0 0 0 0
Not required 20 19 19 58 100
Total 20 19 19 58 100
Resuscitation was not required for any neonate.
Table No-4.21 – APGAR Score (at 1 min.) wise distribution of 58 neonates

No. of Neonates
APGAR Score %
6-8 20 19 19 58 100
5-3 0 0 0 0 0
<3 0 0 0 0 0
Total 20 19 19 58 100
100 % cases had APGAR score in between 6-8 within the one min.
Clinical Study
Table No-4.22 –Assessment of Gest. age (New Ballard Score) wise distribution
of 58 neonates
No. of Neonates
Gestestional age %
40±2 wks 0 0 0 0 0
38±2 wks 20 19 19 58 100
36±2 wks 0 0 0 0 0
Total 20 19 19 58 100
According to new Ballard score the gestational age of all the newborns (58 neonates)
was found around 38±2 wks.
Table 4.23: Average Birth weight wise distribution of all three groups-
Group Average Birth Weight

Group A 2.83 Kg
Group B 2.86 Kg
Group C 2.68 Kg
In group C (trial group) the average birth weight of neonates was 2.68 kg whereas in
group B (Adjuvant group) and group A(control group) average birth weight was 2.86
Kg and 2.83 Kg respectively.
Table No.4.24- Initiation of breast feeding after birth wise distribution of 58
Neonates
No. of Neonates
Initiation of Breast
Feeding Gr. A Gr. B Gr. C Total %
Within 1 hr 4 5 3 12 20.68
Within 2 hr 5 3 5 13 22.42
Within 24 hr 11 11 9 31 53.44
After 24 hr 0 0 2 2 3.46
Total 20 19 19 58 100
st nd
20.68% and 22.42% of the neonates were breast fed within 1 and 2 hour of birth.
53.44% were breast fed within 24hrs whereas only 3.46% were breast fed after 24hrs
of birth.

Clinical Study
Table No. -4.25- Colostrum fed wise distribution of 58 Neonates
No. of Neonates
Colostrum %
Fed 20 19 19 58 100 %
Unfed 0 0 0 0 0
Total 20 19 19 58 100 %
All new born i.e.100% of the neonates were colostrum fed.
Table No- 4.26-: Exclusive Breast feeding wise distribution of 58 Neonates-
No. of Neonates
Exclusive Breast
Feed Gr. A Gr. B Gr. C Total %
Fed 16 17 17 50 86.21
Unfed 4 2 2 8 13.79
Total 20 19 19 58 100 %
Neonates those who are exclusively breast fed were 86.21% and 13.79 % neonates
had no exclusive breast fed.
Table No-4.27- Presence of any Congenital anomoly wise distribution of 58
neonates
Congenital No. of Neonates
%
anomaly Gr. A Gr. B Gr. C Total
Absent 20 19 19 58 100
Present 0 0 0 0 0
Total 20 19 19 58 100
No congenital anomaly was found in any neonate.
Table No-4.28–H/O of Neonatal Care wise distribution of 58 neonates
No. of Neonates
Neonatal Care Gr. A Gr. B Gr. C Total %
Routine 20 19 19 58 100
Special 0 0 0 0 0
Total 20 19 19 58 100

Clinical Study
The routine neonatal care was taken out for all 100 % cases.
Table No-4.29: Effect on Anthropometric parameters- Group A (n=15)
% of
Parameters BT AT SD SE t P
change
Weight 2.83 4.05 43.71 0.26 0.07 14.633 <0.001
Length 48.67 55.80 14.72 1.52 0.39 12.220 <0.001

Head
Circumference 33.47 37.33 11.67 1.35 0.34 6.874 < 0.001
Chest
Circumference 31.47 35.40 12.61 1.21 0.31 7.059 <0.001
In Anthropometric parameters Group A gives highly significant (< 0.001) effect in

weight, height, head Circumference and in chest circumference.
Table No-4.30: Effect on Hematological parameters- Group A (n=15)
% of
change
Hb % 14.57 10.95 -23.24 2.23 0.58 <0.001

-6.282
-1.655
TLC 11773.33 8866.67 17.14 6801 1756 >0.05
-6.502
Neutrophil 57.93 32.33 -44.03 15.25 3.94 <0.001
Lymphocyte 36.00 61.20 80.87 15.48 3.99 6.302 <0.001

2.211
Eosinophil 2.40 3.67 111.83 2.22 0.57 <0.05
0.00
Monocyte 2.73 2.73 34.13 2.39 0.62 >0.05
TRBC 4.55 3.72 -10.68 1.67 0.43 >0.05

-1.913
PLT Count 206.27 398.53 135.60 193.18 49.88 3.855 <0.05
In the hematological parameters highly significant decrease was found in Hb,

neutrophil and significant increase was found in eosinophil and Platelets count,
while lymphocyte count shows highly significant increase, in group A.

Clinical Study
Table No-4.31: Effect on biochemical parameters- Group A (n=15)
% of
Parameters BT AT Change SD SE of t p
Mean
RBS 67.67 77.73 20.29 18.760 4.844 2.078 >0.05
S. Cholesterol 104.67 115.33 51.22 71.959 18.580 0.574 >0.05
SGPT 21.67 48.20 21.79 43.871 21.655 1.225 >0.05
SGOT 61.49 49.60 25.99 53.610 13.842 -0.859 >0.05
T.Bilirubin 2.20 1.73 -2.03 1.131 0.292 -1.621 >0.05
D.Bilirubin 0.62 0.62 7.44 0.522 0.135 -1.646 >0.05
S.Creatinine 0.81 0.47 -21.97 0.803 0.207 -1.639 >0.05
Total Protein 5.90 5.73 -2.22 0.800 0.207 -0.839 >0.05
Albumin 3.54 3.51 -0.07 0.799 0.206 -0.162 >0.05
Globulin 2.38 2.21 -3.08 0.312 0.104 0.641 >0.05
A/G Ratio 1.58 1.83 24.43 0.758 0.196 1.297 >0.05
Blood Urea 20.20 16.80 -15.52 5.667 1.463 -2.324 <0.05
In group A, in case of biochemical parameters only in blood urea significant decrease

was found. Other parameters like SGOT, Total Bilirubin, Direct bilirubin, Serum
Creatinine, Total Protein, Albumin gives statistically insignificant effect.
Table No-4.32: Effect on Anthropometric parameters- Group B (n= 17)
% of
change
Weight 2.86 4.23 48.21 0.246 0.0596 22.965 <0.001
Length 48.82 54.88 12.54 2.926 0.710 8.539 <0.001

Head
Circumference 33.76 40.76 20.75 1.546 0.375 9.414 < 0.001
Chest
Circumference 31.59 35.12 11.27 1.375 0.333 10.586 <0.001
Clinical Study
In group B, all the Anthropometric parameters weight, height, head Circumference

and chest circumference shows highly significant (< 0.001) effect.
Table No.4.33-Effect on Hematological parameters- Group B (n=17)
% of
change
-10.326
Hb % 14.59 10.85 -25.13 1.494 0.362 <0.001
-1.189
TLC 12490.18 10570.59 23.61 6653.97 1613.83 >0.05
-8.902
Neutrophil 54.47 23.94 -54.77 13.486 3.271 <0.001
Lymphocyte 37.29 65.00 86.92 17.954 4.354 6.363 <0.001

0.986
Eosinophil 3.65 4.35 64.38 2.953 0.716 >0.05
0.000
Monocyte 3.35 3.35 4.41 1.173 0.284 >0.05
-5.058
TRBC 4.22 3.58 -14.36 0.523 0.127 <0.001
PLT Count 240.47 412.06 88.33 262.41 63.64 2.906 <0.05
In the case of haematological parameters significant decrease was found

in the Hb, Neutrophill, and total RBC count. While highly significant increase
was found in lymphocyte and significant increase was found in Platelet count, in
group B.
Table No-4.34: Effect on biochemical parameters- Group B (n=17)

% Of
Parameters BT AT SD SE of t p
Change
Mean
RBS 72.00 79.24 14.37 20.584 4.992 1.449 >0.05

S. Cholesterol 70.47 112.94 97.66 49.298 11.956 3.552 >0.05
SGPT 15.41 22.65 87.35 14.303 3.469 2.086 >0.05
SGOT 42.18 41.76 45.95 26.598 6.451 -0.0647 >0.05
T.Bilirubin 1.90 1.59 13.13 1.355 0.0.329 -0.948 >0.05
D.Bilirubin 0.64 0.55 17.81 0.511 0.124 -0.664 >0.05
Clinical Study
S.Creatinine 0.56 0.38 -28.66 0.158 0.0382 -4.923 <0.001

Total Protein 5.36 8.18 57.00 11.662 2.828 -0.994 >0.05
Albumin 3.29 3.57 13.05 0.658 0.160 1.770 >0.05
Globulin 2.02 1.79 -8.47 0.612 0.148 -1.545 >0.05
A/G Ratio 1.171 2.15 37.18 0.786 0.191 -2.309 <0.05
Blood Urea 17.47 16.76 0.51 4.701 1.140 -0.619 >0.05
In the case of biochemical parameters significant decrease was found in the AG ratio
and Sr. Creatinine shows highly significant decrease, in group B. Other parameters
like SGOT, Total Bilirubin, Direct bilirubin, Total Protein, Albumin gives statistically
insignificant effect.
Table No-4.35: Effect on Anthropometric parameters- Group C (n=16)
% of
change
Weight 2.68 4.41 67.95 0.432 0.108 15.276 <0.001
Length 49.50 55.81 12.78 2.387 0.597 10.580 <0.001

Head
Circumference 34.31 37.25 8.64 1.436 0.359 8.182 < 0.001
Chest
Circumference 32.06 35.06 9.42 1.265 0.316 9.487 <0.001
In Anthropometric parameters Group C (Trial drug) gives highly significant (< 0.001)
increase in weight, height, head Circumference and in chest circumference.
Table No-4.36: Effect on Hematological parameters- Group C (n=16)
% of
change
-4.801
Hb % 13.91 10.69 -19.77 2.687 0.672 <0.001
0.920
TLC 10608.75 11443.75 9.59 3631.47 907.87 >0.05
-7.377
Neutrophil 56.19 31.06 -45.48 13.623 3.406 <0.001

Clinical Study
Lymphocyte 36.50 60.75 73.34 14.083 3.521 6.888 <0.001

1.355
Eosinophil 3.31 4.75 136.20 4.242 1.061 >0.05
-0.591
Monocyte 3.44 3.19 7.85 1.693 0.423 >0.05
-2.601
TRBC 4.09 3.60 -9.68 0.751 0.188 <0.05
PLT Count 215.13 475.19 339.08 295.34 73.84 3.522 <0.05
In haematological parameters group C gives highly significant increase in lymphocyte

count while highly significant decrease in Hb, Neutrophil count and significant
decrease was found in total RBC count. Significant increase was found only in
platelet count. Other parameters like, Total Leucocyte Count, Eosinophil and
Monocyte gives statistically insignificant effect.
Table No-4.37: Effect on biochemical parameters- Group C (n=16)
% of
Parameters BT AT change SD SE of t p
Mean
RBS 60.06 76.69 28.34 8.131 2.033 8.178 >0.05
S. Cholesterol 82.50 123.75 67.41 26.687 6.672 6.183 <0.05
SGPT 20.44 17.44 -2.53 9.778 2.444 -1.227 >0.05
SGOT 47.38 51.81 42.33 28.197 7.049 0.630 >0.05
T.Bilirubin 1.81 1.46 -5.74 0.962 0.240 -1.429 >0.05
D.Bilirubin 0.56 0.53 25.51 0.384 0.0961 -0.325 >0.05
S.Creatinine 0.63 0.49 -17.92 0.200 0.0500 -2.876 <0.05
Total Protein 5.33 5.64 7.04 1.045 0.261 1.173 >0.05
Albumin 3.41 3.47 4.10 0.569 0.142 0.439 >0.05
Globulin 1.99 2.29 18.79 1.052 0.263 1.164 >0.05
A/G Ratio 1.79 1.74 1.79 0.661 0.165 -0.307 >0.05
Blood Urea 19.00 18.94 7.37 6.981 1.745 -0.0358 >0.05
In the case of biochemical parameters, group C show significant decrease in S.

Creatinine value while significant increase in S.Cholesterol. Other parameters like
Random Blood Sugar, SGOT, SGPT, Total Bilirubin, Direct bilirubin, Total Protein
Clinical Study
Albumin, Globulin, Blood Urea gives statistically insignificant effect.
Table No-4.38: Comparative effect of Group B and Group A on

% of change
Mean
Features Df t P
Group B GroupA difference
Weight 30 48.21 43.71 -0.136 -1.378 >0.05
Length 30 12.54 14.72 -1.075 -1.236 >0.05

Head
Circumference 30 20.75 11.67 3.133 0.846 >0.05
Chest
Circimference 30 11.27 12.61 -0.404 -0.873 >0.05
On comparison with Group A, Group B did not show statistically significant effects
on Anthropometrical values of neonates.
Table No-4.39: Comparative effect of Group B and Group A on Hematological

parameters:
% of change
Mean
Features Df T P
Group B GroupA difference
Hb % 30 -25.13 -23.24 -0.121 -0.182 >0.05
TLC 30 23.61 17.14 987.07 0.414 >0.05
Neutrophil 30 -54.77 -44.03 -4.929 -1.056 >0.05
Lymphocyte 30 86.92 80.87 2.506 0.420 >0.05
Eosinophil 30 64.38 111.83 0.706 0.737 >0.05
Monocyte 30 4.41 34.13 0.000 0.000 >0.05
TRBC 30 -14.36 -10.68 0.184 0.432 >0.05
PLT Count 30 88.33 135.60 -20.678 -0.267 >0.05
On comparison with Group A, Group B did not show statistically significant effects

Clinical Study
on haematological Parameters like Haemoglobin, Total Leucocyte Count, Neutrophil,

Eosinophil, Lymphocyte, Monocyte, Total RBC and Platelet count.
Table No-4.40: Comparative effect of Group B and Group A on Biochemical
parameters:
Parameters Df % of change Mean t p
Group B Group A difference
RBS 30 14.37 20.29 -2.831 -0.405 >0.05
S.Cholesterol 30 97.66 51.22 31.80 1.473 >0.05
SGPT 30 87.35 25.79 -19.298 -0.935 >0.05
SGOT 30 45.95 25.99 11.469 0.781 >0.05
T.Bilirubin 30 13.13 -2.03 0.162 0.363 >0.05
D. Bilirubin 30 17.81 7.44 -0.083 -0.450 >0.05
S.Creatinine 30 -28.66 -21.97 0.152 0.764 >0.05
Blood Urea 30 0.51 -15.52 2.694 1.470 >0.05
On comparison with Group A (Control Group), Group B (Adjuvant Group) did not
show statistically significant effects on biochemical parameters like Random Blood
Sugar, Serum Creatinine, SGOT, SGPT, Total Bilirubin, Direct bilirubin, Blood Urea.
Table No.4. 41: Comparative effect of group B and group A on Immunological

parameters
% of change
Features Df Mean difference T P
Group B Group A
T.Protein 30 57.07 -2.22 2.985 0.987 >0.05
Albumin 30 13.05 -0.07 0.316 1.226 >0.05
Globulin 30 -8.47 -3.08 -0.0627 -0.208 >0.05
AG ratio 30 37.18 43.71 0.186 0.681 >0.05

Clinical Study
On comparison with Group A (Control Group), Group B (Adjuvant Group) did not
show statistically significant effects on immunological parameters like T.Protein,
Albumin, Globulin and AG ratio.
Table No-4.42: Comparative effect of Group C and Group A on

% of change
Mean
Features Df t P
Group C GroupA difference
Weight 29 67.95 43.71 0.353 1.922 <0.05
Length 29 12.78 14.72 -0.821 -1.082 >0.05

Head
Circumference 29 8.64 11.67 -0.929 -1.787 >0.05
Chest
Circimference 29 9.42 12.61 -0.933 -2.086 >0.05
On comparison with Group A, Group C show statistically significant increase on

Weight Parameter. Other Anthropometrical values show statistically insignificant
effect.
Table No-4.43: Comparative effect of Group C and Group A on Hematological

parameters:
% of change
Mean
Features Df T P
Group C GroupA difference
Hb % 29 -19.77 -23.24 0.395 0.444 >0.05
TLC 29 9.59 17.14 3741.67 1.928 >0.05
Neutrophil 29 -45.48 -44.03 0.475 0.092 >0.05
Lymphocyte 29 73.34 80.87 -0.950 -0.179 >0.05
Eosinophil 29 136.20 111.83 0.171 0.139 >0.05

Clinical Study
Monocyte 29 7.85 34.13 -0.250 -0.338 >0.05
TRBC 29 -9.68 -10.68 0.337 0.733 >0.05
PLT Count 29 339.08 44.07 67.796 0.751 >0.05
On comparison with Group A, Group C did not show statistically significant effects
Table No. 4.44- Comparative effect of Group C and Group A on Biochemical

parameters:
Group C Group A difference
RBS 29 28.34 20.29 6.558 1.277 >0.05
S.Cholesterol 29 67.41 51.22 30.583 1.589 >0.05
SGPT 29 -2.53 215.79 -29.533 -1.400 >0.05
SGOT 29 42.33 25.99 16.324 1.071 >0.05
T.Bilirubin 29 -5.74 -2.03 0.130 0.344 >0.05
D. Bilirubin 29 25.51 7.44 -0.031 -0.191 >0.05
S.Creatinine 29 -17.92 -21.97 0.196 0.947 >0.05
Blood Urea 29 7.37 -15.52 3.337 1.455 >0.05
On comparison with Group A (Control Group), Group C (Trial Group) did not show
statistically significant effects on biochemical parameters like Random Blood Sugar,
Serum Creatinine, SGOT, SGPT, Total Bilirubin, Direct bilirubin, Blood Urea.

Clinical Study
Table No- 4.45: Comparative effect of group C and group A on Immunological

parameters
% of change
Features Df Mean difference T P
Group C Group A
T.Protein 29 7.04 -2.22 0.480 1.428 >0.05
Albumin 29 4.10 -0.07 0.0958 0.387 >0.05
Globulin 29 18.79 -3.08 0.473 1.246 >0.05
AG ratio 29 1.79 24.43 -0.304 -1.194 >0.05
On comparison with Group A (Control Group), Group C (Trial Group) did not show
statistically significant effects on immunological parameters like T.Protein, Albumin,
Globulin and AG ratio.
Table4. 46: Comparative effect of Group C and Group B on Anthropometrical

parameters:
% of change
Mean
Parameter Df t P
Group C GroupB difference
Weight 31 67.95 48.21 0.489 2.914 <0.01
Length 31 12.78 12.54 0.254 0.272 >0.05

Head
Circumference 31 8.64 20.75 -4.063 -1.133 >0.05
Chest
Circimference 31 9.42 11.27 -0.529 -1.149 >0.05
On comparison with Group B (Adjuvant Group), Group C (Trial Group) did not show
Serum Creatinine, SGOT, SGPT, Total Bilirubin, Direct bilirubin, Blood Urea.

Clinical Study
Table No-4.47: Comparative effect of Group C and Group B on Hematological

parameters:
% of change
Mean
Features Df t P
Group C GroupB difference
Hb % 31 -19.77 -25.13 0.516 0.688 >0.05
TLC 31 9.59 23.61 2754.588 1.463 >0.05
Neutrophil 31 -45.48 -54.77 5.404 1.255 >0.05
Lymphocyte 31 73.34 86.92 -3.456 -0.613 >0.05
Eosinophil 31 136.20 64.38 0.732 0.578 >0.05
Monocyte 31 7.85 4.41 -0.250 -0.496 >0.05
TRBC 31 -9.68 -14.36 0.153 0.683 >0.05
PLT Count 31 339.08 88.33 88.474 0.948 >0.05
On comparison with Group B, Group C did not show statistically significant effects
Table 4.48: Comparative effect of Group C and Group B on Biochemical

parameters:
Group C Group B difference
RBS 31 28.34 14.37 9.390 1.703 >0.05
S.Cholesterol 31 67.41 97.66 -1.221 -0.087 >0.05
SGPT 31 -2.53 87.35 -10.235 -2.385 >0.05
SGOT 31 42.33 45.95 4.855 0.509 >0.05

Clinical Study
T.Bilirubin 31 -5.74 13.13 -0.0320 -0.0777 >0.05
D. Bilirubin 31 25.51 17.81 0.0511 0.323 >0.05
S.Creatinine 31 -17.92 -28.66 0.0445 0.712 >0.05
Blood Urea 31 7.37 0.51 0.643 0.312 >0.05
On comparison with Group B (Adjuvant Group), Group C (Trial Group) did not show
Serum Creatinine, SGOT, SGPT, Serum Cholesterol, Total Bilirubin, Direct bilirubin,
Blood Urea.
Table No-4.49: Comparative effect of Group C and Group B on immunological

Parameters:
% of change
Mean
Features Df difference t P
Group C Group B
T.Protein 31 7.04 57.07 -2.506 -0.855 >0.05
Albumin 31 4.10 13.05 -0.220 -1.024 >0.05
Globulin 31 18.79 -8.47 0.536 1.801 >0.05
AG ratio 31 1.79 37.18 -0.491 -1.935 >0.05
On comparison with Group B (Adjuvant Group), Group C (Trial Group) did not
show statistically significant effects on immunological parameters like T.Protein,
Albumin, Globulin and AG ratio
Table No-4.50:Comparative effect of Group C, Group B and Group A on

Anthropometrical Parameters:
Parameters Df Mean score + SEM f p
Group C Group B Group A
Weight 47 1.856±0.161 1.368±0.0596 1.503±0.0802 5.465 <0.01
Length 47 6.313±0.597 6.059±0.710 7.133±0.456 0.834 >0.05

Clinical Study
Head 47 2.938±0.359 7.000 ±3.458 3.867 ± 0.376 1.019 >0.05
Circumference
Chest 47 3.00 ± 0.316 3.529 ± 0.333 3.933± 0.316 2.039 >0.05
Circumferene
After comparison of all the three groups, only weight shows statistically
significant increase (p<0.01) on Anthropometrical values. Other parameters
like Length, Head Circumference, Chest Circumference shows statistically
insignificant effect.
Table No-4.51: Comparative effect of Group C, Group B and Group A on
Haematological Parameter.
Parameters Df Mean score + SEM F p
Hb % 47 -3.225 ±0.672 -3.741±0.362 -3.620±0.576 0.249 >0.05
TLCl 47 835.0 ± 907.87 -1919 ± 1613 -2906 ± 1756 1.711 >0.05
Neutrophil 47 -25.125± 3.40 -30.53± 2.68 -25.60 ± 3.93 0.832 >0.05
Lymphocyte 47 24.250± 3.521 27.71± 4.35 25.20± 3.99 0.207 >0.05
Eosinophil 47 1.438± 1.061 0.706± 0.716 1.267± 0.573 0.228 >0.05
Monocyte 47 -0.250± 0.423 0.716± 0.715 0.00 ± 0.617 0.697 >0.05
TRBC 47 -0.488 ± 0.188 -0.641±0.127 -0.825±0.431 0.382 >0.05
PLT Count 47 260.06 ±73.83 171.59±58.01 192.27± 49.8 0.570 0.569
After comparison of all three groups, haematological Parameters like Haemoglobin,

Total Leucocyte Count, Neutrophil, Eosinophil, Lymphocyte, Monocyte, Total RBC
and Platelet count shows statistically insignificant effect.

Clinical Study

Biochemical Parameter.
RBS 47 16.625±2.033 7.235 ±4.992 10.067± 4.84 1.342 >0.05
S. 47 41.250±6.672 42.471 ±11.9 10.66 ±18.58 1.854 >0.05
Cholesterol
SGPT 47 -3.000 ±2.444 7.235 ±3.469 26.53± 21.65 1.512 >0.05
SGOT 47 4.438 ±7.049 -0.418±6.451 -11.88±13.84 0.767 >0.05
T. Bilirubin 47 -0.344± 0.240 -0.312±0.329 -0.473±0.292 0.0840 >0.05
D.Bilirubin 47 -0.313± 0.096 -0.083±0.124 0.000 ±0.135 0.123 >0.05
S.Creatinine 47 -0.144±0.050 -0.188±0.038 -0.340±0.207 0.731 >0.05
Blood Urea 47 -0.0625 ±1.74 -0.706±1.140 -3.400±1.463 1.417 >0.05
After comparison of all three groups, biochemical parameters like Random Blood
Sugar, Serum Creatinine, SGOT, SGPT, Serum Cholesterol, Total Bilirubin, Direct
bilirubin, Blood Urea shows statistically insignificant effect.

immunological Parameter.
T.Protein 47 0.306 ± 0.261 2.812± 2.828 -0.173±0.207 0.859 >0.05
Albumin 47 0.0625±0.142 0.282 ±0.160 -0.033±0.206 0.922 >0.05
Globulin 47 0.306± 0.263 -0.229±0.148 -0.167±0.274 1.623 >0.05
AG ratio 47 -0.506±0.165 0.440± 0.191 0.254± 0.196 1.850 >0.05

Clinical Study
After comparison of all three groups, immunological parameters like Total Protein,
Albumin, Globulin, AG ratio shows statistically insignificant effect.
References-
1
Vagbhata, Astang Sangraha, comm.. of Indu, Shashilekha, edi. By Shivprasad Sharma, sutra12/7.
Varanasi: Chaukhamba Sanskrit Series Office,reprint 2006, P.no.12.
2
Hemaraja Sarma, Kasayapasamhita of Vrudha Jivaka, Sutrasthana. Varanasi: Chaukhambha
Sanskrit Sansthan. 2013. p.4-5.
3
Miller-Keane Encyclopedia and Dictionary of Medicine, Nursing, and Allied Health, 7th
Ed.Saunders, an Imprint of Elsevier, Inc.2005
4
Sadananda Sharma. Rasataranagini. 15th Taranga, 81. Delhi: Motilal Banarasidas. 2009. p. 379.

Discussion
DISCUSSION
Importance of Swarna Prashana:
In Ayurveda, the nature of foods is grossly divided as Bhakshya (solid), Khadya (Soft
solid), Lehya (Semi solid) and Peya (Liquid)1. Out of these, Lehana is most
appropriate for children to have adequate nutrition as there is under developed
deglutition and chewing ability. By keeping these things in mind, ancient Indian
scientists have given enough stress upon the formulations of Lehana, which are highly
nutritive, immunomodulators and nootropic.
Swarna Prashana is one of the most important Lehana mentioned in Ayurveda which
enhance the qualities like metabolism, physical strength and immunity in children. In
ancient science, various Acharyas have mentioned various Lehana for the newborn
mainly they are the combination of the Ghrita, Madhu and Swarna.2
It can be said that the benefits of Swarna Prashana can be attained from infancy to
adulthood with a wide range of actions influencing the growth and development of a
child. The age at which it can be administered is dependent upon the expected effect
in the body. As a general tonic it can be administered in any age group. For the
benefit as an immuno-modulator it should be administered in children in early ages of
neonatal i.e. one month after birth is considered to be the most vulnerable time for
infectious diseases due to immature immune system. Immaturity of the newborn
immune system leads to a 'physiological immunodeficiency' that encompasses all
arms of the host response as reflected by the increased susceptibility of young
children to infections by both viral and bacterial pathogens.3
Vaccination and its limitations

Vaccines are the antigenic materials consisting of the whole microorganism or
one of its
components. Vaccines are of two types- Killed (inactivated) vaccines-consist of
microorganisms killed by heat or chemicals, and Live attenuated vaccines which
consist of live bacteria or viruses which have been rendered a virulent, they
nevertheless grow and multiply in the body of the host to a limited extent. In
individuals with impaired host defence, e.g. Leukaemia or other malignancies,
especially those receiving cytotoxic chemotheraphy, Systemic lupus erythematosus,
Neonates Page 128
Discussion
Corticosteroid recipients, AIDS and other immune deficiency states, the limited
virulence of organisms in the live vaccine may be sufficient to cause a disease; and
hence live vaccines are contraindicated in them.4 Many of the disease causing
vaccines are under the study such as Cytomegalo vaccine, Gonnococcal vaccine,
Vaccines against parasites- Malaria, Toxoplasmosis, Vaccines against dental caries,
Leprosy vaccine, Vaccine against AIDS etc.5
National Immunization Schedule is implicated, the mortality rate in India is still high.
From the first day of life vaccination schedule get started but these all vaccines do not
able to protect the child from the diseases like major bacterial infections, viral
infections and primary and secondary immunodeficiency syndromes are not
preventable by specific vaccines. Only a few vaccines are successful in preventing
certain diseases like polio, measles, tuberculosis, diphtheria etc. The vaccine takes
almost, two to three months for activation of immune system and to produce the
specific immunoglobulin against that specific antigen. So these are the major lacunas
that lead to increase in perinatal infections.
Hence it is the need of the society to make available a immunomodulatory
agent which boost ups the immune system of body and prevents the infants from
recurrent infections. It should be palatable to child and cost convenient so that it will
be affordable to all type of socioeconomic classes. Looking towards these scenario
and the possible contribution that Ayurveda can ofer in this field this study was
undertaken.
Ayurvedic review-
Jatamatra paricharya (care of the newborn) – The description related to the

Jatamatra paricharya can be devided into two parts, new born care and Jatakarma
samskara.
Care of the newborn can be divided into following steps-
 Basic Neonatal care and Resuscitation

 General care- Bath, Feeding for first 4 days, Bed and cloths,
Protective measures (Raksha karma), Nutrition (Breast feeding)
Pranapratyagaman (Resuscitation of the normal baby) - In intra uterine life, the

phenomenon of nutrition and respiration of the fetus are conducted by the placenta.
Neonates Page 129
Discussion
Hence newborn should immediately be stimulated for the initiation of respiration.

Then the atmospheric oxygen (Amberapiyusha) enters into the baby for its
survival.6While the child is born, the amniotic membranes (Jarayu) rupture, the
phlegm in the throat gets cleared and Vaayu enters inside. So the child starts crying7.
Pranapratyagamana measures mentioned in Ayurvedic classics are the nothing but
the stimulation of the Indriyas.8
Jatakarma Samskara: The word Jatakarma Samskara is composed of two words;

Jatakarma and Samskara. This is the first and the foremost Samskara done to the child
after birth. It possesses socio-cultural and medical importance. The word Jatakarma
specifies the procedures carried out in basic new born baby care at or from the time
of birth. In brief, Jatakarma means a birth ceremony consisting of touching a newly
born child‟s tongue thrice with ghee after appropriate prayers.9 Samskara means a
sacred or sanctifying ceremony, one which purifies from the tent of sin contracted in
10
the womb and leading to regeneration. Acharya Charaka mentions Jatakarma as a
separate procedure itself wherein mixture of only ghee and honey are first
administered in a baby by chanting spiritual hymns followed by initiation of breast
feeding.
Jatamatra Paricharya (new born care) according to the Acharya Charaka:-8

 Sound produced by the striking or rubbing two stones together, near the base
of the ear of the newborn.- stimulation of the Karnendriya.
 Hot or cold water sprinkled on the face of the child- stimulation of the
Sparshanendriya (touch sense).
 Fanning by winnowing baskets made up of black potsherd- stimulation of the
Sparshanendriya.
 Removal of Ulva (vernix caseosa) from the body and oral cavity is to be
cleaned by using Saidhava Lavana (rock salt) and Ghrita or Bala taila -
stimulation of the Sparshanendriya.
 For removal of swallowed Garbhodaka (liquor amnii), emesis should
be induced by administering Ghrita mixed with Saindhava (rock salt) to
the newborn.
 Cutting of umbilical cord and Jatakarma should be performed according to
the rituals-two separate procedures.
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Discussion
Drugs used in Jatakarma Samskara according to Acharya Charaka-11
Drugs Matra Indication

Not exactly
Madhu,Ghrita Single dose at birth
given
Jatamatra Paricharya (new born care) according to the Acharya Sushruta:-12

 Sushruta has changed the sequence of processes for resuscitation and omitted
the process of stimulation of newborn by a sound produced with the help of
two stones.
 Just after birth, Ulva (vernix caseosa) should be removed from the body and
oral cavity is to be cleaned by using Saidhava lavana (rock salt) and Ghrita.
 Murdha (Anterior Fontanel) is to be cared of by covering it with tampon
soaked in Ghrita or Bala-taila followed by cutting of umbilical cord.
 If the child is unconscious due to compression at yoni and /or by instruments
(asphyxiated) should be revived by sprinkling of cold water.
 Jatakarma is performed by administering the mixture of honey, Ghrita and
powder of Ananta (gold) in the dose of one Gunja, by index finger for licking.
 Bath should be given after massaging with Bala-taila.
Drugs used in Jatakarma Samskara according to Acharya Sushruta:-13
Drugs Sahapana Matra Indication
Swarna Churna/ Madhu, Ghrita 1 Gunja Single dose
Bhasma (Dalhana) at birth
Sushruta 14 added special formula feed for the first 4 days of

the baby.
st
1 day – Madhu+Ghrita+Ananta.
nd
2 day- Madhu+Ghrita+Laxmana.
rd
3 day - Madhu+Ghrita+Laxmana.
th
4 day – Breast milk, Navneeta.
After the delivery, it will take 3-4 days for proper quantitative secretion of the
breast milk, during this period a caloric top feed formulas are advised which
helps in fulfilment of the hunger of neonate and his proper sleep. Then after,
up to the age of six months child should be kept on exclusive breast feeding (if
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Discussion
there is no shortage of the breast milk)15.
Jatamatra Paricharya (new born care) according to the Acharya Vagbhata16:-

 Vagbhata has mentioned that after cleaning the Ulva (vernix caseosa), the
revival of deeply unconscious baby should be done by sprinkling of Bala-
taila on the head and making sound by striking of two stones
(details under resuscitation of unconscious newborn).
 Cutting of umbilical cord, bath, protection of Talu, cleaning of the oral cavity
and emesis for swellowed Garbhodaka have been advised as described by
Charaka and Sushruta. Astanga Hridaya has similar description to that of
Astanga Samgraha. According to other authors like Chakradatta17 have
followed the previous authors. Chakradatta has mentioned a separate
recipe for inducing emesis to remove Garbhodaka, i.e. powder of Sunthi,
Krishna Maricha, Pippali, Haritaki, Vacha and Haridra mixed in breast
milk should be given to newborn.18
Drugs used in Jatakarma Samskara according to Acharya Vagbhata19
Drug Sahpana Matra Indication
Indri / indravaruni, Madhu,Ghrita 1 Harenu / 1 Single dose
Brahmi, Vacha Kalaya At birth
Shankhapushpi,
Brahmi, Bala, Ananta,
Durva Shatavari.
These methods are the methods of the auditory stimulation and sensory stimulation to
the neonate. The reflexes of these stimulations may ultimately stimulate the cardio-
respiratory functions and baby will take cry. From a well cushioned, dark, warm and
comfortable aqueous milieu of uterus, the infant when emerges out into hostile
physical environment, providing a valley of sensory stimuli in the form of light,
sound, cold and air makes babies cry. Proper cleaning of oral cavity (including palate,
lips, throat and tongue) is also mentioned to be done by a paediatrician with properly
cleaned finger and trimmed nails with the help of cotton20. If any mucus plug is
getting obstructed in the mouth, then also baby cannot take vigorous cry, hence
cleaning of the oral cavity is very much important.
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Discussion
In the case of the muconium aspirated baby emesis method is mentioned by the
Ghrita mixed with Saindhava (rock salt). By the process of emesis the meconium
from the gastrointestinal track and the respiratory track will come out of the body,
which will helps to clear the airways and baby can breathe easily. This emesis should
be done with the proper precautionary measures because there are a chance of
aspiration of contents into trachea which leads to aspiratory pneumonia.Palpation at
the Brahmarandhra (anterior fontanel) is advised and by putting a cotton pad, soaked
in oil (Bala taila) it told to be protected. The maturity of the foetus is judged by the
examination of the anterior fontanel. The wide anterior frontanelle suggest
prematurity, elevated anterior fontanel suggest increase in intracranial pressure,
cephalohaematoma and caput succedaneum.
 Resuscitation of the unconscious or asphyxiated baby. 

Vagbhata21 is of opinion that if, the child is suffering from fever, deep 
unconsciousness, decreased or unstable Dhatus, hypersensitivity of pain stimuli and
the child looks like almost dead; he should be irrigated with Bala taila and fanning
with winnowing basket (blackened by applying smoke), is done and Mantra to pray
for the life of the baby should be chanted in the right ear of newborn22
These features of asphyxiated newborn baby have quite resemblance with the
APGAR scoring used for assessing the status of the asphyxiated baby. Actually the
features mentioned by Vagbhata are different stages of hypoxia.
The features of the asphyxiated baby as mentioned by Vagbhata can be

correlated with the APGAR score –
Features of Vagbhata APGAR score

Asphyxia (0 criteria)
1 Atiprabala Moha Heart rate absent.
(Deep unconsciousness)
2 Kroshitum Akashyamya Breathing absent.
(No cry even after deep stimulation)
3 Rujanurupa Asamrthasya Muscle tone flaccid
(Hypersensitivity of pain stimuli.)
4 Maranam Anubhavato No reflex response
(Dyeing like appearance.)
The features mentioned by Vagbhata are different stages of hypoxia and

its specific explanation may be given very well. Deep unconsciousness, absence of
cry and dyeing like appearance are the features of severe asphyxia. Severely
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Discussion
asphyxiated newborn is either deeply stuporous or in the coma. He has marked

hypotonia or flaccidity and exhibits the little spontaneous limb movement. Infant
does not cry on painful stimulation. Decreased or unstable Dhatus can be refereed
for poor oxygenation of blood and/or poor cardiac output, due to cardio-respiratory
failure in asphyxiated newborn.
Hypersensitivity of the pain stimuli is the feature of moderate hypoxia. This

stage has definite signs including irritability, vomiting, increased muscle tone and
high pitched poor sustained cry. According to Vagbhata the above features may
also manifest in hyperpyrexia. In newborns, the common cause of hyperpyrexia is
septicaemia, which may present various features including above signs. Such child,
if not revived properly, may have various serious complications (cerebral palsy
etc.), as a result, proper growth and development may not be achieved by the child.
By observing this, Vagbhata has mentioned that in these children attainment of
youth is doubtful.
Table 5.1:Formulations used for Jatakarma Samskara according to

Sharngadhara, Bhavaprakasha, Yogaratnakara and Acharya Kashyapa -
No Reference Drugs Sahapan Matra Duratio

. a n
1. Sharangdhar Swarna churnam Madhu, 1 Gunja Single
Samhita23 /Bhasma Ghrita (Dalhan dose at
) birth
2. Bhavaprakasha24 Swarna Bhasma, Madhu Not Daily
Kustha, Vacha ,Ghrita given from
churna, birth to 1
Swarna Bhasma, year or
Brahmi and 12 years.
Shankhapushpi
churna
Swarna Bhasma,
Arkapushpi and
Vacha churna
Swarna Bhasma,
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Discussion
Kayaphala and Sweat

durva.
25
Yogaratnakara Swarna Madhu, Not Daily
Bhasma,Kustha,Vach Ghrita given from
a Birth to
Swarna Bhasma, 1 year or
Brahmi and 12 years.
Shankhapushpi
churna
Swarna Bhasma,
Arkapushpi and
Vacha churna
Swarna Bhasma,
Kayaphala and Sweat
durva
Bhaishajyaratnavali Swarna Bhasma, Madhu, 1 Ratti, Daily
26
Kustha, Vacha, Ghrita 1Tola from
Haritaki, Brahmi Birth to
1 year or
12 years.
Kashyapa Shuddha Swarna Madhu, Not Daily

Samhita27 Ghrita given from
Birth to
6
months.
Mode of action of the Jatakarma Samskara-
Chanting the mixture of honey and Ghrita could be a congruent foreign

substance (antigen) to the body while honey collected from flowers various Rasas and
Gunas is likely to possess a variety of substances or allergens in buffer state. The
pollen of the flower is known allergen; hence this may be alarm the baby‟s immune
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Discussion
mechanism to establish general immunity. The ghee component of mixture (fat)

which, after digestion bypasses the liver to reach the heart may preserve the said
antigen from being immediately metabolised by the liver thus facilitating its existence
for the purpose.
The growth and development of brain is maximum during the early infantile
age of children, the head circumference reaching 45 cms. at one year which was 32 to
34 cms, at birth. Hence this may be the reason why Ayurvedic Acharyas advocate
Prashana of certain substances to the newborn daily right from the first day itself
whereby central nervous system may be appropriately stimulated resulting into the
various advantages.
Concept of lehana-
Lehana is the speciality of the Kashyapa, he has given special emphasis on

Lehanakarma (process of chanting by tongue) and a separate chapter called
Lehadhyaya is allocated in Kashyapa Samhita, Sutra-sthana.28
Several materials for Lehana are enlisted in the Adhyaya, this includes all varieties of
drugs, viz. Medhya, Balya, Deepana, Pachana etc. Kashyapa mentioned all of the
materials with reference to children only whereas the other classics described them in
general. Many of these materials are to be given to the neonate and the purpose or
objectives of this to induce immunity besides other aspect like longevity, intelligence,
complexion etc. Some other Lehna indicated for the infants during weaning might be
aimed at extending as food of supplemental value whereas some other Ghritas or
powders advocated during Bala Vikasa might be to support growth and development
by augmenting anabolism and some others are directly advised in certain diseases.
The Lehana preparations of Acharya Kashyapa serves the dual purposes, they
fulfil the nutritional requirement of the body as well as they are used as
supplementary foods. The children who either cannot get sufficient breast milk due to
various reasons or they are not able to receive required calories, though having good
digestive power, thus, suffer from the emaciation etc. have only been advised these
Lehana.xxviii
Contraindications of the Lehana seem to be mainly for Kaphaja disorders, though the
certain other conditions have also been mentioned. It is established fact that the any
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Discussion
diet other than the mother‟s milk requires better digestive power. The children whose
digestive power is influenced due to some reason or who suffer from the jaundice,
oedema etc. need very special dietetic regimen and cannot be given general
supplementary food. Amongst the various contraindication of the Lehana, the Ama
dosha and Alasaka are also added. Ama dosha refers to the metabolites produced due
to indigestion (mild to severe), while Alasaka seems to be the description of stasis of
food or its sluggish movement with or without any severe complications according to
Charaka29 and Vagbhatas30 and the paralytic ileus or intestinal obstructions as per
the description of Sushruta31, in these conditions also routine supplementary foods
cannot be given.
Sublingual or the buccal route of administration found to be similar with

Lehana. Within the oral mucosal cavity, the buccal region offers an attractive route of
administration for systemic drug delivery in which the drug is placed under tongue or
crushed in the mouth and spread over the buccal mucosa32. Within the oral mucosal
cavity, delivery of drugs is classified into three categories: (i) sublingual delivery,
which is systemic delivery of drugs through the mucosal membranes lining the floor
of the mouth, (ii) buccal delivery, which is drug administration through the mucosal
membranes lining the cheeks (buccal mucosa), and (iii) local delivery, which is drug
delivery into the oral cavity.
As Lehana has the same concept of route of administration for the children in
concern to palatability and convenience. There are two permeation pathways for
passive drug transport across the oral mucosa: paracellular and transcellular routes.
Permeates can use these two routes simultaneously, but one route is usually preferred
over the other depending on the physicochemical properties of the diffusion. Since the
intercellular spaces and cytoplasm are hydrophilic in character, lipophilic compounds
would have low solubility in this environment. The cell membrane, however, is rather
lipophilic in nature and hydrophilic solutes will have difficulty permeating through
the cell membrane due to a low partition co-efficient. Therefore, the intercellular
spaces pose as the major barrier to permeation of lipophilic compounds and the cell
membrane acts as the major transport barrier for hydrophilic compounds..33Acharya
Kashyapa has described all Ghrita based Lehena formulations in his Lehanadhaya of
Sutrasthana like Samvardhna Ghrita, Kalyanaka Ghrita, Panchagavya Ghrita,
Bhrahmi Ghrita etc. these all are the lipophic substantances are mainly advised to be
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Discussion
administered through the sublingual route. They are get absorbed through the
sublingual mucosa which is relatively permeable, giving rapid absorption and
acceptable bioavailabilities of many drugs, and is convenient, accessible, and
generally well accepted by the babies.
Nowadays, Sublingual Immunotherapy (SLIT) is method of allergy treatment
that uses an allergen solution given under the tongue, which over the course of
treatment, reduces sensitivity to allergens. Sublingual immunotherapy, or SLIT, has a
very good safety profile and is given at home in adults and children34.It is the practice
of administering gradually increasing doses of the specific causative allergen to
reduce the clinical reactivity of allergic subjects, and is the only treatment targeting
the causes of hypersensitivity and not only the symptoms, as done by drugs 35.
Sublingual immunotherapy is taken as drops or tablets, placed under the tongue 3 or
more times/week, containing a specific allergen which interacts with the immune
system to decrease allergic sensitivity. Commonly the allergen is taken once a day.
The antigen persists on the mucosal surface and is taken up by dendritic cells which
interact with T lymphocytes (T-cells). Dendritic cells in the oral mucosa act as
antigen presenting cells (APC) to T-cells in the cervical lymph nodes. This system
modulates the allergic response by creating immune tolerance to antigens. Early in
treatment, sublingual dendritic cells secrete interleukin 10 (IL-10) which induces
regulatory T cells to inhibit the inflammatory response. Long term changes that occur
with immunotherapy include a decrease in mast cell sensitivity and a decrease in IgE
production by B-cells. Allergic symptoms improve as the underlying basis of the
allergic disease improves.36 This mechanism of the SLIT is similar with that of the
Madhu-Ghrita prashana or Swarnaprashana Yoga, in which the antigenic material
honey with Ghrita is administered for its better transport and absorption, the added
Swarna bhasma further enhances the immune system of body and act as an overall
immmodulatory therapy.
Concept of immunity and immunization in Ayurveda-

In Ayurveda the term Vyadhikshamatva is used right from the period
Charaka37 to denote the functional principle of disease resistance. It would be wrong
to interpret narrow stustructural identification to Vyadhikshamatva, which has broad
and loose sense. Keen observation substantiates that human being has two different
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Discussion
varieties of strengths.
 The strength required for the growth of the body and to perform routine
activities is called energy (Bala).
 The strength required to protect the body against several diseases is called
resistance (Ksamatva).
The term immunity is the nearest term that may be correlated with this.
Another term, which literally means strength or force is Bala. The statements such as
“Balam Hyalam Doshaharam, Baladhishtanamarogyam” etc. points out that
according to Ayurveda it is Bala which fights disease, prevents it, cures it or at least
checks it to such an extend so that life will be possible even at the cost of certain
faculties.
Sushruta and his commentator Dalhana38used the term Bala to signify Ojas
and stated Bala is the power of the body sufficient to resist disease. The Bala is
threefold39 i.e. Sahaja Bala- innate or natural inherited or constitutional, Kalaja Bala–
temporal based on seasonal and age factors, and Yuktikrita Bala– acquired through
means of diet, drugs or drug combinations and other regimens.
Sahaja Bala comprehends both body and mind, being innate and inborn, it
exists from birth, Kalaja Bala is influenced by seasonal characteristics. Bala is at its
lowest during spring and summer; it is conserved to maximum level during rainy
season, autumn and winter. Yuktikrita Bala is acquired through dietetic regimens,
restorative and Rasayana therapies. The Sahaja Bala in modern parlance is innate
immunity, and the Yuktikrita Bala is acquired immunity.
The Bala or Ojas is the basis of Vyadhikshamatva or immunity. Vyadhikshamatva
is interpreted as Vyadhibala Virodhitva – antagonistic to the strength and virulence of
disease, and Vyadhyutpadaka Pratibandhakatva – the capacity to inhibit or contain or
neutralize or resist or overcome disease causing agents which may be Adibhautika in
origin implying Bhuta or living creatures, microbes, viruses and other agents that invade
th
the body. Up to 20 week of the foetus the Ojas of sperm and ovum will work and there
will be a little supply from the mother. Therefore a regular supply of Ojas is to be
maintained from the mother‟s reservoir through the placental blood. This helps the foetus
th
in gaining weight, colour and vitality.40 It seems that in the 8 month the demand for
Ojas is more by the foetus. If the child doesn‟t get sufficient amount, the child will not
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Discussion
be well. Delivery at this time will give rise to a stillbirth or the birth of a child, who is
extremely unviable.41
The measures of improving the Bala are of three ways Samskaras, Rasayana
and Vajikarana. The Samskara means to bring purification, description of Shodhasha
Samskara is aimed at celebrating the functional achievements of a child. The
„Samskara‟ means those religious rites and ceremonies which scantify the body, mind
and intellect so that the person may become fit for the society. There are several
objects of the Samskaras, as can be seen from the Mantras and symbolism used in the
ceremonies. These can be broadly divided into two categories; to invoke beneficence
from the kindly Gods and to keep away or remove hostile or evil powers that beset
human life at various stages.
The word Rasayana refers to nutrient Rasa and its transportation in the body
to nourish and replenish the other Dhatu42 The process covers the nutrient fraction
and its subsequent metabolic transformation and transportation under the influence of
different Agni of the body in the formation of Ojas. Ojas represents vitality, vigor and
capacity to resist decay and disease. Ojas is the Sara or quintessence of Dhatu. It is
responsible for promoting the stability and strength of organs of the body. The seat of
Ojas is Hridaya43 it is the seat of vital breath. The loss or deficiency of Ojas leads to
wasting, decay and degeneration44. The Vajikarana therapy is only to promote sexual
potentialities. It is absolutely partial and incomplete understanding. The Atulyagotra
concept45 of Ayurveda provides genetic clues for immunological considerations.
Various classifications of men according to physical, mental and generic types
also are of importance in the contemplation of Ayurvedic immunology. The
fundamental principles of Ayurveda have direct relations with immunity and the
problems confronted by immunology. The promotion of the Shukra is to be the
promotion of the Ojus which sustains the immunity of the body. Such Vajikara drugs
are Guru, Madhura, Snigdha, Jivana, Brimhana properties.46 These are the
Ojovardhaka drugs which ultimately increases the Ojus acts as immunomodulatory
action.
Immunoglobulin G-as biomarker-

Antibodies (also known as immunoglobulins47, abbreviated Ig) are gamma
globulin proteins that are found in blood or other bodily fluids of vertebrates, and
are used by the immune system to identify and neutralize foreign objects, such as
Neonates Page 140
Discussion
bacteria and viruses. Immunoglobulin G (IgG) is antibody molecules. Other

Immunoglobulins may be described in terms of polymers with the IgG structure
considered the monomer. IgG constitutes 75% of serum immunoglobulins in
48
humans . IgG molecules are synthesized and secreted by plasma B cells. There are
four IgG subclasses (IgG1, 2, 3 and 4) in humans, named in order of their abundance
in serum (IgG1 being the most abundant).
IgG is most prevalent immunoglobulin in human serum, making up 75-80% of
total immunoglobulin. Binding of IgG to the three classes of Fc receptors expressed
on the overlapping sets of macrophages, granulocytes, lymphocytes, NK cells,
neutrophills, eosinophills mediate such function as antibody-dependent cellular
cytotoxicity and transfer of IgG from mother to fetus49. The average half life of IgG is
21 days but the IgG metabolism shows the significant variation among the
individuals50. The active infection, endocrine disorders and autoimmunity have all
been associated with increase IgG catabolism51.
Circulating mature T and B lymphocytes are present in the fetus from the
second trimester and lymphocyte number rise with the gestation. However,
lymphocyte responses to the antigens, particularly immunoglobulin production are
limited until birth. Maternal IgG is transferred to the fetus during the third trimester
via the placenta and makes ups for the deficient of intrinsic IgG production in the
neonate. The protective effect of the maternal immunoglobulin depends on the mother
having appropriate antigen specific IgG antibody. The immune response matures
quite rapidly after birth. Initially IgM is produced but as a maternal IgG decays
intrinsic IgG responses develops. By 2 months of the age Infant can produce IgG
responses to protein and conjugated vaccine antigen. As the maternal IgG level
decays the nadir in IgG levels between 3-6 months, which may be prolonged while
IgG production is developing52
IgG in immunodeficiency diseases:

IgG is well distributed in intravascular and extravascular spaces and is important
in the secondary antibody responses (immune memory). It plays an important role in
host defence against infection. IgG protects tissues from bacteria, viruses, and toxins.
Different subclasses of IgG neutralize bacterial toxins, activate complement, and
enhance phagocytosis by opsonization.
IgG deficiency leads a pattern of organ-specific infection (i.e. otitis media,
sinopulmonary infection), recurrent infections with same organism, systemic
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Discussion
infections, dental and oral disease, autoimmune diseases as well as recurrent or

chronic pyogenic respiratory tract infections.
In the cases of IgG subclass deficiency the patient may be asymptomatic between
episodes of acute infection, although even minor reductions in the total serum
concentration can be associated with a deficiency of specific antibodies (eg,
antibodies to bacterial polysaccharides) and increased risk of infection with
Streptococcus pneumoniae, Haemophilus influenzae type b, and Staphylococcus
aureus. Many patients with IgG2 or specific polysaccharide antibody deficiency have
recurrent respiratory conditions such as bronchiectasis, bronchopneumonia,
bronchitis, obstructive lung disease, and hyper-reactive airways, which often presents
as " asthma." Patients with monoclonal gammopathy of unknown significance and
multiple myeloma often have functional antibody deficiencies. Bacterial infection as a
result of such a deficiency is a common morbid complication53. Hence the normal
serum IgG level is the indication of the proper immunological response against the
pathogens.
Selection of Drug and Dosage from:

Swarna Prashana is a widely practised formulation in paediatric age group with
various claims like immunity enhancer, memory enhancer, Ayurvedic immunisation
etc. among the public. But there are no standard formulations followed anywhere in
clinical practice. The selected formulation for the present study was by taking the
reference of Kashyapa Samhita.
Swarna Prashana used in the present study contained Swarna Bhasma, ghee (cow
ghee) and honey. It is mentioned by Acharya Charaka that, Baalo
Mrudubheshajeeyanam54 which means that children are those in whom only soft/
gentle medicines should be administered. All the ingredients in the selected
formulation possess Madhura Rasa, Sheeta Virya and Madhura Vipaka,55 56 57
58
which specifies the gentle nature of the selected drug. Swarna Bhasma is praised
specifically as Atyanta Madhura (extremely sweet).59 Due to the special qualities of
Swarna Bhasma it is indicated in infants and children.60Thus the selected drug can be
entitled as a highly suitable drug in infants.
The properties of Swarna Bhasma like Rasayana, Hrudya, Balya, Vishapaha and
Param Ojo Vivardhana are the attributes to its effect on immune system. The action
of gold in immune system can be justified from the following study reports:
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Discussion
 In a pharmco-clinical study on neonates Madhu-Ghrita-Swarna-Vacha

combination showed a significant effect on humoral anti-body formation. The
effect of this formulation on immunological system was evident by a rise in
the total proteins and serum IgG levels.61
 Pharmacological studies showed specific and nonspecific immune responses
which were modified in a positive manner in Swarna Bhasma-treated mice. It
also had a stimulatory effect on peritoneal macrophages, which may be helpful
to fight against infections.62 63
The properties of ghee as Balya, Ojovardhana64 and honey

Sukshmamarganusari65,Yogavahi 66act as complimentary to that of Swarna Bhasma.
Drug administration errors are common in infants. Although the early infant age
group has a high exposure to drugs, there are few data concerning pharmacokinetics
or pharmacodynamics, or the influence of paediatric diseases on these processes.
Children remain therapeutic orphans. Formulations are often suitable only for adults;
in addition, the lack of maturation of drug elimination processes, alteration of body
composition and influence of size render the calculation of drug doses complex in
infants.67 Most of the current findings state the same status of drug administration in
infants, whereas Ayurveda has got ample guidelines to be followed in such
circumstances. It starts from the selection of the drug followed by the dosage,
adjuvant and method of administration.
Thus the drug selected for the present study matches the qualities of a drug
which is suitable for children as mentioned by Acharya Charaka as Madhura (sweet),
Kashaya (astringent), Mridu (soft) and it should not be highly Snigdha (oily), Ruksha
(dry), Ushna (hot), Amla (sour) and of Katu Vipaka (pungent after digestion) and
Guru (heavy to digest).68
Although administration of Swarna in children is described as Leha or Prasha,
practical difficulties in dose fixation and drug administration made a new thought of
the dosage form as drops. To standardize the dosage in drops a specific proportion of
Swarna Bhasma, ghee and honey were selected as it was practically difficult to
prepare drops in lower proportions due to viscosity of honey and solidification of
ghee in room temperature. The specific proportion of 1:4 of ghee and honey
respectively was calculated in drops from dropper bottle used in the study to which
315mg Swarna Bhasma was added. Thus when prepared in bulk for 315mg of Swarna
Neonates Page 143
Discussion
Bhasma, 11gm of ghee (1drop of ghee = 22mg) and 127gm of honey (1 drop of honey
= 62mg) were added. By following this proportion one dose (5 drops) of Swarna
Prashana would contain approximately 0.7 mg of Swarna Bhasma which is the
dosage of 2.5Kg babies, calculated as per Clark‟s rule by taking adult dose of Swarna
Bhasma as 20mg.
Analytical Study
Organoleptic characters:
The organoleptic characters being subjective in nature cannot be evaluated
numerically for reproducibility in the results. There were no much differences
between the trial and adjuvant drugs in appearance, taste, smell and consistency as
both of the formulation had major ingredients as honey and ghee. The mixture of
honey and ghee after eight hours of trituration became a moderately thick, soft and
viscous liquid which could be administered easily in the form of drops. The dark
brown colour of the trial drug was due to the presence of Swarna Bhasma in it which
is having a brick red colour. Adjuvant drug was much of yellowish brown colour
which was as expected in a mixture of ghee and honey. Although honey and ghee
were found to be immiscible at first, after trituration for eight hours it formed a
homogenous mixture.
Pharmaceutical study:
The trial and adjuvant drugs in the present study contained both ghee and
honey in similar proportions. As it was a mixture of a fat (ghee) and water soluble
(honey) ingredients the pharmaceutical parameters analysed were limited. Suitable
parameters like Loss on drying, Water and Alcohol soluble extractive and Sugar
estimation were performed. The values obtained were helpful to develop a standard
for the reproducibility of Swarna Prashana of the same quality thereby ensuring
uniform therapeutic efficacy. The value of Loss on drying of group C (Trial drug) was
13.60% w/w when compared to group B (Adjuvant drug) i.e. 11.26% w/w suggested
slightly higher moisture content in group C (Trial drug). But the differences in values
were very minimal which might have come only by chance. Loss on drying
determines the amount of volatile matter (i.e., water drying off from the drug). For
substances appearing to contain water as the only volatile constituent, this procedure
is appropriately used.69The second most component of honey is water.70The higher
Neonates Page 144
Discussion
moisture content in both the samples are also indicative of hygroscopic nature of
honey, which is the major content of the formulation. High moisture content in a
formulation cautions the higher chances of microbial contamination which can be
minimized by suitable preservation and packing techniques like storage and
dispensing in sterilized containers. The water soluble extractive values of both trial
(79.16% w/w) and adjuvant (82.18% w/w) drugs were nearly similar. Higher
percentage of water soluble extractive in both the drugs may be indicating the
abundance of water soluble sugar content in the formulation as honey primarily
contains sugar which is about 95-99% of honey dry matter71. Higher percentage of
alcohol soluble extractive of both trial (80.14% w/w) and adjuvant (79.88 % w/w)
drugs may be because of the higher amount of alcohol soluble constituents in honey
and ghee.
The results of this study is suggestive that the physico-chemical properties of

both the trial and adjuvant drugs are mainly influenced by the presence of honey in
the formulations as it is the major content compared to ghee. The values obtained may
be used as the reference standard in further research undertakings of its kind. The
pharmaceutical analysis of the formulations also helped in monitoring the stability of
the drugs in the present study with respect to microbial contamination.
Microbiological study:
Microbiological study was aimed at monitoring the stability of group C (Swarna

Prashana Yoga) and group B (Madhu-Ghrita Yoga) with respect to microbial
contamination in the four selected samples of each groups prepared and stored in two
different climatic conditions and temperature. The raw drugs, ghee and honey were
also subjected to similar study before preparation of the samples which showed no
positive results suggesting the genuine nature of the selected raw drugs as per their
designated standards. A baseline microbial profile was studied at regular intervals i n
different climatic seasons for a period of 11 months (1st Batch) and 5 months
(2nd Batch). At the end of the study it was observed that all the samples of 1st Batch
and 2nd Batch containing both groups i.e. group B(Madhu-Ghrita) and group C
(Swarna -Madhu-Ghrita) preserved at room temperature as well as in refrigerator
during the months of March 2015 to Jan 2016 and September 2015 to Jan 2016 did
Neonates Page 145
Discussion
not show presence of any microbes or fungal filaments at the end of 11 months
and 5 month after preparation of drug.
In a previous research study Swarna Prashana Yoga (Swarna-Madhu-Ghrita)

preserved in room temperature during the months of September to November
2013 showed presence of many gram negative pleomorphic rods on 37th day of the
Gram stain test. But no mycological finding was observed in it. While the
formulation preserved in refrigerator showed negative results in wet mount test at the
end of 3 months. But in gram stain test it showed presence of many gram negative
rods arranged singly on 86th day of preparation. The month of September in 2013
received heavy rain fall in Jamnagar district and during October to December 2013
received average 27% higher rainfall in Jamnagar district during which, low
temperature, high humidity and moisture content of the atmosphere might have
also influenced the positive microbial contamination findings in the samples during
those period.72
In the present study of Swarna Prashana Yoga and mixture of Madhu-Ghrita, Madhu
(Honey) an ingredient, was of comparatively higher quantity than ghee. Approximate
aw value of honey is < 0.60. 73 Honey is hygroscopic in nature. The amount of water
absorb in honey is dependent upon the relative humidity of the air. Although the
water activity value of honey is high, a change in that value might have taken place in
the samples due to change in climatic conditions and temperature. Negative findings
of any microbial and fungus formation in all samples of both batches at room
temperature as well as at refrigerator, during the month March 2015 to Jan 2016 and
September 2015 to Jan 2016 which may be due to low degree of humidity which
depends on natural rainfalls and the flow of moist wind and also depends upon
proper hygienic conditions during preparation and storage. In 2015 there is low rain
fall in Jamnagar Gujarat city and average minimum and maximum temperature was
noticed 21.7ºC and 38.9 ºC respectively.74 The level of microorganisms in the air is
controlled by degree of humidity, size and level of dust particles, temperature and air
velocity and resistance of microorganisms to drying. Generally dry air with low dust
content and higher temperature has low microbial level.
Neonates Page 146
Discussion
Microorganisms need water to grow and will die without water sources. Moist areas
are particularly prone to bacterial growth. Water content in any medicinal product also
provides an excellent environment for microorganisms to grow.75
The degree of humidity depends on natural rainfalls and the flow of moist winds.
During the year of 2015, Jamnagar was one of among the drought area. In said
environment the test carried out on the samples of both batches, the observation
obtained are cited in analytical study ( table no. 1,2,3 and 4).The results indicate that
the prepared drugs samples are free from any microbial and fungus formation
(fungi). Hence it is being proved that if Madhu-Ghrita and Swarna Prashana yoga
are kept in ideal packages, after making appropriate specified materials and then
further it is preserved under normal temperature, pressure, light and dry (damp-less)
air (below normal degree of humidity), the shelf life of these formulations are nearly
one year.
Neonates Page 147
Discussion
CLINICAL STUDY
The current study entitled “A Randomized controlled clinical trial on Swarna
Prashana in neonates w.s.r. to its Immunomodulatory Activity” is a Randomized,
Single Centre, Fixed Dose, Parallel Group, Adjuvant and Placebo (distilled water)
Controlled Clinical Study to assess the Role of Swarna Prashana (Administration of
Gold) in immunomodulation of neonates.
In the present study the neonates were assigned by chance to separate groups
that compared different treatments. Using chance to assign subjects to group meant
that the groups will be similar and that the treatments they receive can be compared
objectively. Hence to compare the efficacy of trial (Swarna Prashana Yoga), adjuvant
drug (Combination of Madhu -Ghrita) with placebo controlled group (distilled water),
randomization was selected. The present study was conducted at single center i.e.
neonates delivered at I.P.D. of I.P.G.T & R.A. hospital. and those are registered in
I.P.D. of Kaumarbhritya, I.P.G.T & R. A. Jamnagar for the convenience of the
researcher and participants. Administering fixed dose in the present study helped to
assess the time period required for the subjects to respond to the medication in the
prescribed dose. All the groups received fixed dose of five drops once in a day,
morning followed by feeding. The drug schedule was fixed based on present day
clinical practice and the classical reference as per Kashyapa Samhitha.76 Drug was
administered for a duration of six weeks, as it was a study to evaluate the effect of
Immunomodulatory activity of Swarna Prashana and the specific effect of the same
had explained by Acharya Kashyapa as “Vyadhibirna Cha Drushyate” if administered
for a period of 1 month.lxxvi
This research design was selected because the trial was conducted in three
separate groups of subjects simultaneously who were under group A (distilled water),
group B (Madhu-Ghrita) and Group C (Swarna-Madhu-Ghrita)). The results obtained
in the three groups were then compared to see if the investigational treatment was
more effective in producing immunomodulation in the neonates. Hence a controlled
study method was selected. As per the legal mandate any interventional study
involving human participants should get clearance from the IEC and should be
registered in CTRI. The Present study too was started only after getting ethical
clearance from IEC, IPGT and RA, Jamnagar and the study has been duly registered
in CTRI-retrospectively which makes the study more authentic.
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Discussion
Observations made in the clinical study:
Chart No.-1 Distribution of Neonates in different groups-
Status of Enrolment
Total 58
48
10
Group C 19
16
3
Group B 19
17
2
Group A 20
15
5
0 20 40 60 80
Registered Completed Discontinued
In the present study a total of 58 neonates were registered based on inclusion criteria;
19 in group C (Swarna Prashana), 19 in group B (Madhu-Ghrita) and 20 in group A
(Distilled water). Out of which in group C 16, group B 17 and in group A 15
completed the treatment. Three neonates in C group, 2 neonates in B group and 5
neonates in A group discontinued the treatment in between. The major reason for
discontinuing the treatment was the fear of prick by the parents. None of the parents
in all the three groups had complaints on medication and were satisfied with the
counselling and medication.
Table no. 5. 2- Reason for drop outs in all the three groups-
Group A – 5 drop outs Group B – 2 drop outs Group C – 3 drop outs
Fear of prick- 3 Fear of prick - 2 Fear of prick - 2
Family problem - 2 Family problem - 0 Family problem -1
Chart no.2– Demographic data of neonates in the trial
Neonates Page 149
Discussion
Demographic Data of the Neonates in the Trial
14 13
12 12 12 12
12 11
10 10 10
10 9 9 9 9
8 8
8 7 7
6
6
0
Male Female Hindu Muslim Rural Urban
Gender:
Number of Male neonates represented 11, 9 and 9 in group A, group B and in group C
respectively. Total 29 (50%) male neonates enrolled in present study. Whereas
number of female neonates represented 9, 10 and 10 in group A, group B and in group
C respectively, total 29 (50%) female neonates enrolled. This data shows that in the
present study there is no difference in the distribution of neonates according to their
sex. There is no specific relation to Immunodeficiency with the sex of the newborn.
Both the sex are equally susceptible for the condition.
Religion:
In group C 13 (68.42%) neonates belonged to Hindu religion and 6 (31.58%)

belonged to Muslim religion. In Group B 12 (63.16%) and 7 (36.84%) neonates
belonged to Hindu and Muslim religion respectively. Whereas in group A, 12 (80%)
and 8 (40%) neonates belonged to Hindu and Muslim religion respectively. The data
may be attributed to the Hindu dominant community in the area of the study.
Neonates Page 150
Discussion
Habitat:
47.34%, 36.84% and 40% of the neonates belonged to rural habitat in group C, group
B and in group A respectively. 52.66%, 63.16% and 60% of the neonates belonged to
urban habitat in group C, group B and in group A respectively. This data just reflects
the population which attends the hospital.
Parental education, SES (Table no.4.5,4.6,4.7)

In the present study mothers of maximum cases (56.90 %) were having primary
education, followed by 31.04 % secondary education and 5.17 % were higher
secondary educations as well as illiteracy. Only 1.72 % graduates mothers. Whereas
Fathers of maximum cases (44.83 %) were having primary education, followed by
41.38 % secondary education and 12.07 % were higher secondary educations, only
1.72 % graduates.
According to their economic status, it was observed that maximum number (74.14%)
of parents was belonged to middle class, whereas 20.69 % and 5.17 % belonged to
lower middle class and lower class respectively. No parents from higher income class.
Various observational and clinical studies have proved that educational
qualification of parents has a major role to play in the health status of a child. The
same is evident in routine practice also. This is because educated parents will be
having fewer misconcepts on health issue as well as they follow the instructions given
by the physicians or health activists properly. In case of meeting the health care
expenditure of the child (including immunization) and maintaining hygiene and in
case of residential conditions also the socio economic status plays a role.
This data again shows the general trend in the population attending the OPD
of Govt. hospital where the medical service is offered free of cost. The reason for
more number of lower and middle class patients is that though they can afford the
cost of medication, the hospital where the study was conducted is the only Ayurvedic
hospital having good facilities and better patient care.
Antenatal history (Table no.4.8-4.12)

In the Antenatal history, only seven i.e. 12.07% mother were irregular in antenatal
checkups during their antenatal period. No any maternal history of major illness
found. Total 84.48% of the mothers consumed medications like Folic acid, Vitamins,
Iron, Calcium, Ayurvedic drugs etc. while 12.06% of the mothers did not consume
Neonates Page 151
Discussion
any medications during antenatal period. Among 84.48% of the mothers who
consumed medications 70.68% were consuming Ayurvedic medications.
Maximum i.e. 55.18 % of the mothers were in their second parity where as
25.86 % mother were primi. All pregnant women had taken 2 doses of Inj.TT. The
gravidae and parity denotes the pregnant state both at present and past. It also gives a
clue for the duration of the delivery. Maximum mothers in the study were second
gravidae; it is just for data retrieval.
Natal history (Table no.4.13-4.23)

Maximum number of cases i.e. 54 (93.10 %) had the spontaneous onset of
delivery, only
four cases were augmented onset of delivery. All babies were delivered normally only
five babies delivered normal with vacuum assestence. No major complications are
found during the delivery in any of the cases. All babies cried vigorously soon after
the birth. Hence oxygen or resuscitation were not required in any of the cases. All
babies had APGAR score in between 6-8 (within 1min). According to New Ballard
Score the gestational age of the newborns was found to be around 38±2 wks. In group
C (trial group) the average birth weights of neonates are 2.68 kg whereas in group B
(Adjuvant group) and group A (control group) average birth weights are 2.86 Kg and
2.83 Kg respectively.
The data suggests that all the newborns are full term and without any signs of
fetal asphyxia. It has been reported in many pediatric texts that children who had
assisted delivery and problem in the delivery may develop problems in the future life
especially that are related to the growth and development. The uninterrupted growth
and development are essential for healthy life and one deprived of this may develop
problems in health including that related with immune system. In the present study no
such observations are found, also the newborn suffering from the birth asphyxia,
premature or LBW (Low Birth Weight) were found; such newborn need the special
neonatal and the chances of Infections are seen more in them.
Postnatal history (Table no.4.24-4.28)
Maximum number i.e. 53.44% of neonates initiated breast feeding within 24 hour of
birth, rest 20.68% and 22.42% of the neonates were breast fed within first and second
Neonates Page 152
Discussion
hour of birth. Only 3.46% were breast fed only after 24hrs of birth. All the neonates
i.e. 100% were colostrum fed. Neonates those who are exclusively breast fed were
86.21% and 13.79 % neonates had no exclusive breast fed. No any kind of congenital
anomaly was found in any of the cases. No any type of illness was seen during the
neonatal period in any of the cases. The cord fell around 5-9 days without any
complication. The routine neonatal care was provided to all the cases.
The data suggest that the all the neonates were healthy and they were under
the proper care with aseptic conditions.
Effect of therapy:
Table no-5.3: Consolidated table of effect of therapy on individual group.
Parameters Group A Group B Group C
Anthropometrical Parameters
Weight HSI HSI HSI
Length HSI HSI HSI
Head HSI HSI HSI
Circumference
Chest HSI HSI HSI
Circumference
Haematological Parameters
Hb% HSD HSD HSD
TLC NSD NSD NSI
Neutrophils HSD HSD HSD
Lymphocytes HSI HSI HSI
Eosinophils HSI NSI NSI
Monocyte NSI NSI NSD
TRBC NSD HSD SD
Neonates Page 153
Discussion
PLT count SI SI SI
Biochemical parameters
RBS NSI NSI NSI
S. Cholesterol NSI NSI SI
SGPT NSI NSI NSD
SGOT NSD NSD NSI
T. Bilirubin NSD NSD NSD
D.Bilirubin NSD NSD NSD
S.Creatinine NSD HSD SD
Total Protein NSD NSD NSD
Albumin NSD NSI NSI
Globulin NSI NSD NSI
AG ratio NSI SD NSD
Blood Urea SD NSD NSD
Abbrevations used:
NSI- Non Significant Increase NSD- Non Significant Decrease
SI- Significant Increase SD- Significant Decrease
HSI- Highly Significant Increase HSD- Highly Significant Decrease
GROUP A (Table no.4.29-4.31) - Group A showed highly significant results in

anthropometric measurements viz weight, height, chest circumference and head
circumference. In the hematological parameters highly significant decrease was
found in Hb, neutrophil and significant increase was found in eosinophil and
Platelets count, while lymphocyte count shows highly significant increase. In the
case of biochemical parameters significant decrease was found in value of blood
urea.
Neonates Page 154
Discussion
GROUP B (Table no.4.32-4.34) - In the Group B, all the anthropometric values

showed highly significant increase. In the case of haematological parameters
significant decrease was found in the Hb%, neutrophil, and total RBC count, while
highly significant increase was found in lymphocyte and significant increase was
found in platelet count. In the case of biochemical parameters, significant decrease
was found in the AG ratio and highly significant decrease was found in S.
Creatinine.
GROUP C (Table no.4.35-4.37) - In group C, all the anthropometrical parameters

showed highly significant increase. In haematological parameters, highly
significant increase in lymphocyte count was found while highly significant
decrease in Hb%, neutrophil count and significant decrease was found in total RBC
count. Significant increase was found only in platelet count. In the case of
biochemical parameters, group C showed significant decrease in S. Creatinine
value while significant increase in S. Cholesterol. Significant increase in S.
Cholesterol was found only in C group (Swarna-Madhu-Ghrita). This effect is due
to Brimhana response of the Swarna-Madhu-Ghrita combination.
The significant result in the anthropometric values signifies that the growth
of neonates is normal during six weeks of life. The significant changes in the
haematological and biochemical parameters are due to the normal physiological
variation of the values in cord blood and in venous blood after six weeks and they
are within normal reference range. The highly significant increase in the
lymphocyte count signifies the initiation of the immunological response after the
immunization of BCG and OPV vaccines.
Table – 5.4: Consolidated table of comparative effect of therapy.
Parameters Group B to A Group C to A Group C to B

Anthropometrical parameters
Weight SIE SSI SSI
Length SIE SIE SIE
Head Circumference SIE SIE SIE
Chest Circumference SIE SIE SIE
Neonates Page 155
Discussion
Haematological parameters
Hb % SIE SIE SIE
TLC SIE SIE SIE
Neutrophils SIE SIE SIE
Lymphocyte SIE SIE SIE
Eosinophil SIE SIE SIE
Monocyte SIE SIE SIE
TRBC SIE SIE SIE
PLT count SIE SIE SIE
RBS SIE SIE SIE
S.Cholesterol SIE SIE SIE
SGPT SIE SIE SIE
SGOT SIE SIE SIE
T.Bilirubin SIE SIE SIE
D.Bilirubin SIE SIE SIE
S.Creatinine SIE SIE SIE
Blood Urea SIE SIE SIE
T.Protein SIE SIE SIE
Albumin SIE SIE SIE
Globulin SIE SIE SIE
AG ratio SIE SIE SIE
Abreviations used-
SIE – Statistically Insignificant Effect SSI – Statisticaly Significant Increase.
Comparative effect of Group B and Group A (Table no.6.36-6.39) -
On Anthropometrical parameters: On comparison there was statistically
insignificant effect found between both the groups, which suggested that Adjuvant
drug (Madhu-Ghrita) and Control drug (distilled water) did not hamper normal
growth of the neonates and the Adjuvant drug did not have any additional effect on
enhancing the anthropometrical values.
Neonates Page 156
Discussion
On Hematological parameters: On comparison there was statistically insignificant

effect found between both the groups.
On Biochemical parameters: On comparison there was statistically insignificant

effect found between both the groups.
Above results suggested that all the values of haematological and biochemical
parameter were within normal limits. These limits suggest that Adjuvant drug and
control drug did not interfere with the normal physiology.
Comparative effect of Group C and Group A (Table no.6.40-6.43) -

On Anthropometrical parameters: Weight parameter, showed statisticaly
significant increase in group C as compare to group A. The significant effect found in
group C is due to the addition of Swarna Bhasma which rectifies the anabolic effect
of Madhu-Ghrita.
On Hematological parameters: On comparison there was no statistically
significant difference between both the groups.
On Biochemical parameters: On comparison there was no statistically significant

difference between both the groups.
Above results suggested that all the values of haematological and biochemical
parameter were within normal limits. These limits suggest that Trial drug and control
drug did not interfere with the normal physiology
Comparative effect of Group C and Group B (Table no.6.44-6.47) -

On Anthropometrical parameters: Weight parameter, showed statisticaly
significant increase in group C as compare to group B. The significant effect found in
group C is due to the addition of Swarna Bhasma which rectifies the anabolic effect
of Madhu-Ghrita.
On Hematological parameters: In the case of haematological parameters all the

parameters of group C shows insignificant results as compare to group B.
On Biochemical parameters: In the case of biochemical parameters also, all the
parameters of group C shows insignificant results as compare to group B.
Neonates Page 157
Discussion
Table-5.5: Consolidated table of comparative effect of therapy in all three

groups-
Parameters Group C to Group B and A
Anthropometrical parameters
Weight SSI
Length SIE
Head Circumference SIE
Chest Circumference SIE
Haematological parameters
Hb% SIE
TLC SIE
Neutrophil SIE
Lymphocyte SIE
Eosinophil SIE
Monocyte SIE
TRBC SIE
PLT Count SIE
RBS SIE
S.Cholesterol SIE
SGPT SIE
SGOT SIE
T.Bilirubin SIE
D.Bilirubin SIE
Neonates Page 158
Discussion
S.Creatinine SIE
Total Protein SIE
Albumin SIE
Globilin SIE
AG ratio SIE
Blood Urea SIE
Abreviations used-
SIE - Statistically Insignificant Effect SSI – Statisticaly Significant
Increase.
On Anthropometrical parameters: -Weight, shows statisticaly significant increase

in group C as compare to group B and A. The significant effect found in group C is
due to the addition of Swarna Bhasma which rectifies the anabolic effect of Madhu-
Ghrita.
On Hematological parameters: On comparison there was no statistically

significant difference between all the groups.
On Biochemical parameters: On comparison there was no statistically significant
effect found between all the groups.
Follow Up study-
Up to the three and half months of age in follow up study all the Infants
achieved the proper developmental milestones i.e. neck holding (gross motor
milestone), social smile and recognizing of mother (personal social milestone),
turning head to sound and cooing (language milestone).
Table no. 5.6:Prevalence of disorders in followup period in neonates-
Frequency of common illness in group C-
Frequency of common illness

Group C
1st follow up 2nd follow up 3rd follow up 4th follow up
URTI - - 1 -
GIT - - - -
Others - - - -
Neonates Page 159
Discussion
Frequency of common illness in group B-

Group B
URTI - - 2 1
GIT - - 1 -
Others - 1 - -
Frequency of common illness in group A-

Group A
URTI - 2 1 1
GIT - - 2 -
Others - - - 1
Occurrence of mild cold in 1 neonates of group C arise question about sustained

effect of the therapy but the mildness of the complaint itself indicated its action as
Vyadhi Bala Virodhitwam (Protective action against diseases). In group B complain
of cough-cold in two ninfants, Loose stools in one infant and skin disease found in
one infant. In group A complain of cough-cold in three infants, Loose stools and
abdominal pain in two infant and skin disease found in one infant.
In the follow up study it was observed that the episodes of recurrent upper
respiratory tract infections, diarrheal episodes and skin problems are infrequent or
absent in group C as compare to other groups A and B.
No any Adverse drug reaction was reported in the study.
Probable mode of action:

The extent to which a drug is bound to circulating plasma proteins directly
influences the distribution characteristics of the drug. Only the free, unbound drug
can be distributed from the vascular space into other body fluids and tissues, where
it binds to its receptor and stimulates a response. The local environment in the
Neonates Page 160
Discussion
mouth is regarded as a site of natural immune tolerance. Sublingual immunotherapy

in optimal doses is effective and may induce remission after discontinuation and
prevent new sensitizations, features consistent with induction of tolerance. Swarna
Prashana administered in the form of drops could also be acting in a similar way on
immune system. As stated in a study report, it was proved that the absorption of
gold preparation in vitro 10% of gold goes into the solution and so in living
organism greater quantities can be expected as absorbed.77 Another study reveals
that nanoparticles can be absorbed through sublingual route directly into the blood
stream.78
Recent research has revealed that gold nanoparticles show size-dependent absorption
through rat skin and intestine that smaller particles (~15nm) absorbed more than
larger particles (>100nm).79
To be effective, a drug must be absorbed from its site of administration into the
systemic circulation, from where it is distributed to its site of action and eliminated
from the body. Bioavailability is a measure of the amount of drug absorbed into the
systemic circulation over a finite period. Likewise the absorption profile of a drug is a
composite that depends on both the bioavailability (amount) and the rate of absorption
into the systemic circulation. The rate and extent of drug absorption are influenced by
a number of physicochemical and patient-related factors.80 As the above cited studies
confirm the absorption of nanoparticles, in the present study the gold nanoparticles in
the trial drug which was in the form of Swarna Bhasma might have absorbed into the
body through both sublingual and intestinal route and reached the target site of action.
Proven in a study the action of gold can be considered as the catalytic stimulation of
the reticulo-endothelial system or general defence mechanism.81
Neonates Page 161
Discussion
Chart 3 : Mode of action of Swarna Prashana Yoga
Swarna Prashana
Rasa – Madhura, Kashaya Virya – Sheeta

Guna – Sheeta, snigdha, pichhila & Vipaka - Madhura
guru
Karma – Kapha vardhana, Vata – Pitta shaman, deepana,

Dhatu poshna, brumhana, vishapaha paramaojo vivardhna,
rasayana
Yuktikruta
Bala
Neonates Page 162
Discussion
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Neonates Page 167
Summary And Conclusion
SUMMARY
The present clinical study entitled “A Randomized Controlled Clinical Trial
on Swarna Prashana and its Immunomodulatory activity in Neonates” was aimed at
determining the efficacy of Swarna Prashana Yoga in immunomodualtion of healthy
neonates. Suitable criteria were used for assessment of the parameters. The present
study was planned under different sections which are as follows:
CONCEPTUAL STUDY:
The basic concepts related to the present study were thoroughly studied,
compiled and presented in conceptual part of the study which included two parts
namely, Review of literature and Drug review. In the section of review of literature,
the concept of Swarna Prashana, Jatamatra Paricharya, Lehana, Jatakarma
Samskara and Vyadhikshamatwa, from various Samhitas and other Ayurveda texts
were reviewed and compiled. Relevant materials on Immunity, Immune system,
Immunoglobulins and other related topics from various sources such as modern text
books, journals, publications and websites were collected and organized. Information
on trial drug from various research sources as well as texts were also reviewed and
presented. Drug review dealt with the detailed description about the contents of the
test formulations in the present study. The pharmacodynamics and pharmacological
actions of the ingredients i.e. Swarna Bhasma, ghee and honey were collected from
various sources in both Ayurvedic and modern parlance along with related research
findings. The method of preparation of both the trial and adjuvant drugs were
explained in detail.
ANALYTICAL STUDY:
Analytical study was undertaken to evaluate and compare the raw drugs and
the prepared formulations with the standard parameters in different steps. Physico-
chemical analysis was limited to some basic parameters only due to the nature of the
formulation, loss on drying, water and alcohol soluble extractive values and sugar
estimation were done. Analysis of organoleptic parameters was also carried out.
Microbiological study of both trial and adjuvant drugs was conducted at regular
intervals for a period of 11 months to monitor the stability and shelf life of the
formulations with respect to microbial contamination.
Neonates Page 168
CLINICAL STUDY:
The present clinical study was designed as “A Randomized, Single Centre,

Single Blind, Fixed Dose, Parallel Group, Placebo and Adjuvant-Controlled Study for
the role of Swarna Prashana Yoga for bringing about immunomodulation in
neonates”. The clinical study was started after the approval of Institutional ethics
committee [No. PGT/7-A/Ethics/2014-2015/1538]. Research work has been
registered in CTRI- CTRI/2015/11/006337 [Registered on: 02/11/2015] - Trial
Registered Retrospectively.
The neonates were enrolled into three groups namely Group A (Placebo
group), Group B (Adjuvant groups) and Group C (Trial group). Trial group received
Swarna Prashana drops prepared with Swarna Bhasma, ghee and honey once a day
in morning. The dosage of Swarna Bhasma was calculated according to Clark’s rule.
Adjuvant group received a mixture of ghee and honey in the form of drops in similar
schedule. The study was for a period of 6 weeks and a follow up of 8 weeks after the
trial. Suitable laboratory investigations were carried out before and after treatment.
Clinical response to medication was assessed based upon subjective and objective
parameters namely changes in the values of haematological and biochemical before
and after treatment, the pattern of growth and development with respect to
Anthropometry and the frequency of diseases of child / attack of common illness and
response to treatment are observed.
Total of 58 neonates were registered in the study out of which 48 completed
the treatment and 10 discontinued. In Group C (Trial group) 19 neonates were
registered out of which 16 completed the full course of treatment and 3 discontinued,
in Group B (Adjuvant group) 19 neonates were registered out of which17 completed
the full course of treatment and 2 discontinued, whereas in Group A (Placebo group)
20 neonates were registered out of which 15 completed course of treatment and 5
discontinued.
DISCUSSION:
In this part of the work, the observations and results made in the analytical,
and clinical studies were collected, data generated were interpreted using suitable
statistical tests to check the level of significance of the study. Effects of therapy and
probable mode of action of the drug were discussed in detail. After a logical
discussion on various components and aspects of Swarna Prashana and its effect on
Neonates Page 169
Immunomodulation with scientific interpretation and supportive data, the following

conclusions were made.
Based on the study carried out following a well structured research protocol,
and scientific evidence based discussions, the following conclusions are made:
CONCLUSIONS
 Acharyra Kashyapa coined the term Swarna Prashana under the context of 

Lehana. 

 The word Swarna Prashana depicts the administration of gold along with ghee
and honey with or without herbal drugs in the form of Lehana/Prashana (by
licking). 
 There is no classical reference of any specific day for Swarna Praashana. 

 Swarna, Ghrita and Madhu possess the properties which are most suitable for
administration in children as explained in Ayurvedic classics. . 

 Microbiological study revealed the probable stability period of both trial and
adjuvant drugs with respect to microbial contamination as nearly one years in hot
and dry climate. . 
 The results in clinical study showed statistically highly significant (p < 0.001)
effects of trial, adjuvant and placebo drug on all the anthropometrical
measurements of neonates. But on comparison only weight shows statistically
significant increase in group C (trial group), other anthropometrical parameters
did not show statistically significant changes. These results suggest that Swarna
Prashana Yoga have any additional effect on enhancing the weight
anthropometric value. In the follow up study it was observed that the episodes of
common illness (recurrent upper respiratory tract infections, diarrheal episodes
and skin problems etc.) are infrequent or absent in trial group as compare to other
groups A and B.
 The results of Renal function and liver function tests were in normal limits even
after completion of treatment which suggests that the drug was safe to be
administered in neonates.
 Hence it can be concluded that trial drug (Swarna Prashana Yoga) is having
significant immunostimulant action as evident found in the results of clinical
study.
Neonates Page 170
Scope for future study 


 Multi-centric studies with large sample size in different age groups can be
beneficial in understanding the role of Swarna Prashana Yoga further. 

 Studies after modifying the duration of administration of Swarna Prashana for 6
months daily will be beneficial to assess the effect of the yoga for its Medhya
activity. 
Neonates Page 171
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 www.iapindia.org.page
 www.media.net
 http://www.fda.gov
 www.gujaratweather.com
 http://www.healthact.com
 www.ijaronline.com
 www.imdagrimet.gov.in
 http://www.innovationservices.philips.com
 http://www.medscape.com
 http://www.medicine.ox.ac.uk
 http://medical dictionary.thefreedictionary.com
 http://www.meoweather.com
 http://ndb.nal.usda.gov
 http://www.ncbi.nlm.nih.gov
 http://onlinelibrary.wiley.com
 http://www.progenresearchlab.com
 http://pathmicro.med.sc.edu
 http://pharmacology.uthscsa.edu
 http://www.slideshare.net
 http://www.sticindia.com
 http://timesofindia.indiatimes.com
Neonates Page v
CONSENT FORM
Title: A RANDOMIZED CONTROLLED CLINICAL TRIAL ON SWARNA

PRASHANA AND ITS IMMUNOMODULATORY ACTIVITY IN
NEONATES.
Name of scholar: Dr Poonam Singh
Name of Baby:
I, …………………………………………….exercise my free power of choice on

behalf of my baby to be included in the clinical trial of a drug which helps in
normalizing the immune status of my baby. I have been informed to my satisfaction in
my own language by the attending physician, the purpose of the clinical trial, the
nature of the drug administration and follow up, including the laboratory investigation
to monitor and safe guard body functions of my baby. I am also aware of my right to
opt out at any time during the course of the trial without having a reason for doing so.
मैं..………………………….................................अऩने बच्चे को अऩनी सहमती से प्रस्तत

ु शोधकाययमें
शाममऱ कराने के मऱये तैयार हुुं जजस दवायी से मेरे बच्चे का रोगप्रततरोध शजतत aµCi हो
जएगा. सम्बजधधत चचककत्सक से मेरे अऩने भाषा में मझ
ु े दवायी के प्रयोग के बारे में सब
कुछ बता ददया गया है . मेरे बच्चे की स्वस्थता को ध्यान ् रखते हुए इस शोध कायय में रतत
ऩरीऺण समय समय ऩर एवुं चचककत्सीय ऩरीऺण ककये जायेंगे. मैं इस शोध कायय से कभी
भी अऱग होने का अचधकार रखता हुुं जजसके मऱए मझ
ु े कोई भी कारण बताने की आवश्यतता
नही है .
હ,ું ……………………………………………………..મારી શમતિથી મારા બા લકને શુંબતું ધિ

ચિકકત્શાદ્વારાપ્રસ્તિચિકકત્સ્કીય અનશુંધાન માું઴ામે઱ કરળા શુંમિછું ,જેમારાબાલક ની
રોગપ્રતિરોધ ઴ક્તિને શમાળસ્થામાું રાખળા માટે ઉ઩યોચગ છે .
શુંબધીિચિકકત્શકેમનેમારીભાવામાું દળાનાું પ્રયોગ તળ઴ેબધજજણવ્યછે.
મારાબાલકનીસ્ળસ્થિાનેધ્યાનમારાખીનેઆ઴ોધકાયયમારતિ઩રીક્ષણઅનેશમયશમય઩રચિકકત્શકી
ય઩કરક્ષણ કરળા માું આળ઴ે, જેનાતળ઴ેમને શું઩ણય માકષિી આ઩ે઱ છે .
મારાબાલકનીબધીજમાષીિીઅનેનામગપ્િરાખળામાુંઆળ઴ે. ચિકકત્શકીય અનશુંધાનઅદ્યયયન
દરતમયાન કોઇ઩ણ સ્િરે કારણ આપ્યા તળના અદ્યયન માુંથી મતિ થળાનો મને શું઩ણય અતધકાર
છે , િે તળ઴ે હ ું જાણ છું.
Signature of physician Signature of Parents/Guardian
Date:
RESEARCH PROFORMA FOR CLINICAL STUDY
DEPARTMENT OF KAUMARBHRITYA
I.P.G.T. & R.A., GUJARAT AYURVED UNIVERSITY, JAMNAGAR-361008.
Title: A RANDOMIZED CONTROLLED CLINICAL TRIAL ON SWARNA

PRASHANA AND ITS IMMUNOMODULATORY ACTIVITY IN NEONATES.
Scholar: Dr.Poonam Singh Year: 2013-2016
Guide: Dr. K. S. Patel. Co-Guide: Dr. V. K. Kori, Dr. Rajagopala S.
Name-B/o- SI. No.- Group: A / B / C
Age- Starting Date of medicine:
Sex: M/F Completion Date of medicine:
Date of birth: O.P.D.No:
Time of birth: I.P.D.No:
Religion: H / M /C / O Patient Cot No.-
Cast: Course Completed: Yes / Dropped out.
Address:
Contact No.- Socioeconomic Status L/ LM / M / UM / U.
BIRTH HISTORY-
1. ANTENATAL HISTORY
1. Age of mother during Pregnancy:
2. Regular Antenatal check-ups done: Yes/No
3. Presence of any major illness: Yes/No If yes what-
4. Medications: Yes/No If yes what-
5. Supplements- FSFA / Calcium / Multivitamins
6. TT Vaccine taken: Yes / No
7. Investigations done: Yes / No If yes what-

2. NATAL HISTORY-
1. G- P- A- L- D-
2. Place of delivery: Hospital/Home/others
3. Type of labour: Spontaneous/Induced/Augmented

4. H/o Prolonged labour: Yes/No Approximate duration-
5. Drugs used during labor- Analgesics/Anaesthetic/other/not known
6. Type of delivery: Vaginal - Normal/Forceps/Vaccum LSCS- Indicated/ Optional
7. Any evidence of Foetal distress:
8. Complications during delivery (if any):
9. Single Baby/twins/others
3. POSTNATAL HISTORY-
1. Cried soon after birth: Yes / No
2.. Type of Cry: Vigorous / feeble / poor.
3. Suction: Done / Not required.
4. Oxygen: Given / Not required.
5. Resuscitation: Done/Was not required.
6. Vital signs:
RR- /min. HR- /min. CRT-
7. APGAR score (If available): ____ in 1 min;* ____ in 5 min; ____ in 10 min;
Sign 0 1 2
Appearance
Pulse
Grimace
Activity
Respiration
Total
(*APGAR Score detaile is for 1 min)

8. Birth Weight: Kg
9. Starting of Breast Feeding: Colostrum given: Yes / No
10. Passage of Meconium: Urine:
11. H / O Severe Jaundice / Seizure / Fever / Other:
12. Neonatal Reflexes:
Rooting:
Sucking:
Swallowing:
Moro’ s :
Glabbellar tap:
13. Assessment of gestational age: (According to the New Ballard score pattern)
-1 0 1 2 3 4 5
Skin Sticky, Gelatinous Smooth Superficial Crackin Parchment Leathery,
Friable, Red Pink Peeling g ,deep, Cracked,
Transparent Translucen Visible And/or Pale Cracking Wrinkled
t Veins Rashes, Areas No
few veins Rare vessels
Veins
Lanugo None Sparse abundant thinning Bald- Mostly
areas bald
Plantar Heel-toe <50mm,no Faint red Anterior Creases Creases
Surface 40-50mm Creases marks Transverse on ant. Over
Crease 2/3 only Entire sole
only
Breast Imperceptible Barely Flat Stripped Raised Full
perceptible Areola- Areola,1- Areola, Areola,5-
no 2mm bud 3-4mm 10mm
bud bud bud
Eye/Ear Lids fused, Lids open, Slightly Well firm, Thick
Loosely -1 pinna flat curved curved instant cartilage,
Tightly -2 ,stays pinna, pinna, soft Formed ear stiff
folded soft slow but ready and
recoil recoil recoil
Genitals Scrotum flat, Scrotum Testes in Testes Testes Testes
Male smooth empty, upper desending, down, pendulous,
faint rugae canal few rugae good deep rugae
rare rugae
rugae
Genitals Clitoris Prominent Prominen Majora and Majora Majora
Female prominent, clitoris, t clitoris, minora large, covers
labia flat small labia enlarging equally minora clitoris &
minora minora prominent small minora
Neuromuscular maturity:-
Maturity rating:-
Score Weeks L.M.P-

-10 20 E.D.D-
-5 22 Gestational age_________wks.
0 24
5 26
10 28
15 30
20 32
25 34
30 36
35 38
40 40
45 42
50 44
Congenital anamolies- Present / Absent

FAMILY & SOCIAL HISTORY
H/O any diseases in the family:
Consanguinity if present- 1 / 2 / 3
Name Age Education Occupation
(during conception)
Father-
Mother-
Area of housing: Rural/Urban/Slum

Social/ Cultural practices: Kajal/ SomvaChotris/ JalaramChamcha/ Bala goli/ Gulthuthi
(w.r. to child rearing)
PERSONAL HISTORY:
1. Feeding:
Exclusive breast feeding: Yes/No
Any feeding difficulties: Yes/No
Any top feeds given: Yes/No
2. Appetite:
3. Bowel: Regular / Irregular ______ Times / day Any Complains-
4. Micturition: Regular / Irregular ______ Times / day Any Complains
5. Sleep: Regular / Irregular ______Hrs / day _____ Hrs / night.
GENERAL EXAMINATION :
No. Parameter BT DT AT
1. Appearance
2. Cry
3. Skin
4. Pallor
5. Icterus
6. Cyanosis
7. Oedema
8. Temperature
9. Pulse/H.R. /min /min /min
10. R. R. /min /min /min
11. Status of Cord/ Umbilicus
ASSESSMENT
ANTHROPOMETRY
No. Parameter BT DT AT Follow up
1. Weight ( Kg )
2. Length ( Cm )
3. Head Circumference ( Cm )
4. Chest Circumference ( Cm )
Developmental milestones-
No. Milestone Normal Age of Observation

Development
DT AT Follow
up
1. Gross motor-
i. Neck holding 3 months
2. Personal social-
i. Social smile 2 months
ii. Recognizing 3 months
mother
3. Language-
i. Turns head to 1 months
sound
ii. Cooing 3 months
FREQUENCY OF COMMON ILLNESS:
Frequency of Common DT AT Follow up

illness
URTI
GITI
Others
INVESTIGATIONS
HEMATOLOGICA BT AT UNIT BT AT
L
D.L.C
Hb gms% N%
T.L.C Cells/Cumm L%
Total R.B.C mil/Cumm E%
E.S.R mm/hr M%
Platelets count 103/ul B%
BIO-CHEMICAL BT AT UNIT BT AT UNIT
R.B.S mg/dL S.Creatinine mg/dL
S.Cholesterol mg/dL Total protein gm/dL
SGPT IU/L Albumin gm/dL
SGOT IU/L Globulin gm/dL
Bilirubin (T) mg/dL A-G Ratio
Bilirubin (D) mg/dL Blood Urea mg/dL

IMMUNIZATION HISTORY
No. Name of Vaccine Dose Given / Not given

1. BCG Single Yes/No
2. Polio – OPV/IPV 0/1st /2nd /3rd Yes/No
3. Hepatitis B 1st /2nd /3rd Yes/No
4. HiB 1st /2nd /3rd Yes/No
5. DTPw 1st /2nd /3rd Yes/No
TREATMENT SCHEDULE:
1 . Group: A/ B / C
2. Drug: A. Control B. Madhu – Ghrita C. Swarna-Madhu-Ghrita.
3. Dose: 5 drops in a single dose at morning.
4. Duration: 6 weeks.
FOLLOW-UP (every fort night):
At 1 stvisit-
At 2nd visit-
At 3rdvisit-
At 4th visit-
Guide Scholar
Dr. K. S. Patel Dr.Poonam Singh

REF/2015/07/009406
CTRI Website URL - http://ctri.nic.in
Clinical Trial Details (PDF Generation Date :- Sat, 21 Nov 2015 12:22:38 GMT)
CTRI Number CTRI/2015/11/006337 [Registered on: 02/11/2015] - Trial Registered Retrospectively

Last Modified On 30/10/2015
Post Graduate Thesis Yes
Type of Trial Interventional
Type of Study Drug
Ayurveda
Preventive
Screening
Behavioral
Study Design Randomized, Parallel Group, Placebo Controlled Trial
Public Title of Study vyadhikshamatva effect of swarnaprashana
Scientific Title of A RANDOMIZED CONTROLLED CLINICAL TRIAL ON SWARNA PRASHANA AND ITS
Study IMMUNOMODULATORY ACTIVITY IN NEONATES
Secondary IDs if Any Secondary ID Identifier
NIL NIL
Details of Principal Details of Principal Investigator
Investigator or overall
Name Poonam Singh
Trial Coordinator
(multi-center study) Designation MD second year
Affiliation IPGTRA Jamnagar
Address Institute for postgraduate teaching and research in ayurved
Jamnagar Gujarat Jamnagar 361008 Gujarat India IPGTRA
Jamnagar Gujarat ayurved university Jamnagar361008 Gujarat India
Jamnagar
GUJARAT
361008
India
Phone 7376016085
Fax
Email punnusing@gmail.com
Details Contact Details Contact Person (Scientific Query)
Person (Scientific
Name Dr V K Kori
Query)
Designation Astt professor
Affiliation IPGTRA Jamnagar Gujarat ayurved university Jamnagar
Address IPGTRA Jamnagar Gujarat ayurved university Jamnagar Gujarat
India IPGTRA Jamnagar Gujarat ayurved university
Jamnagar361008 Gujarat India
Jamnagar
GUJARAT
361008
India
Phone 9374548475
Fax
Email drvkkori@yahoo.co.in
Details Contact Details Contact Person (Public Query)
Person (Public Query)
Name Prof K S Patel
Designation Professor and HOD
Affiliation IPGTRA Jamnagar Gujarat ayurved university Jamnagar
Address IPGTRA Jamnagar Gujarat ayurved university Jamnagar Gujarat
India IPGTRA Jamnagar Gujarat ayurved university
page 1 / 3
REF/2015/07/009406
Jamnagar361008 Gujarat India

Jamnagar
GUJARAT
361008
India
Phone 9427574566
Fax
Email drkspatel2007@yahoo.co.in
Source of Monetary or Source of Monetary or Material Support
Material Support
> Institute for postgraduate teaching and research in ayurveda Gujarat ayurveda university
Jamnagar 361008
Primary Sponsor Primary Sponsor Details
Name IPGTRA GAU Jamnagar
Address IPGTRA GAU Jamnagar
Type of Sponsor Research institution and hospital
Details of Secondary Name Address
Sponsor
NIL NIL
Countries of List of Countries
Recruitment
India
Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email
Investigator
DrPoonam Singh Department of IPD of Kaumarbhritya,I 7376016085
Kaumarbhritya PGT&RA Jamnagar
IPGT&RA Jamnagar Gujarat punnusing@gmail.com
Jamnagar
GUJARAT
Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics
Committee Committee?
INSTITUTIONAL Approved 02/09/2014 No
ETHICS COMMITTEE
Regulatory Clearance Status Date
Status from DCGI
Not Applicable No Date Specified
Health Condition / Health Type Condition
Problems Studied
Healthy Human Volunteers Healthy neonates
Intervention / Type Name Details
Comparator Agent
Comparator Agent Distilled water Distilled water for 6 weeks with
drop form
Comparator Agent Madhu-Ghrita Madhu-Ghrita for 6 weeks with
drop form
Intervention Swarna-Madhu-Ghrita Swarna-Madhu-Ghrita for 6
weeks with drop form
Inclusion Criteria Inclusion Criteria
Age From 0.00 Day(s)
Age To 3.00 Day(s)
Gender Both
Details 1. Full term healthy newborn. (Gestational age between 37-42 wks)
2. Birth weight > 2.5k.g
Exclusion Criteria Exclusion Criteria
page 2 / 3
REF/2015/07/009406
Details 1. Preterm child (Gestational age 2. Post term child. (Gestational age
> 42 wks)
3. Birth weight 4. Birth asphyxia.
5. Infectious diseases.
6. Congenital anomalies.
7. Hereditary diseases.
Method of Generating Computer generated randomization

Random Sequence
Method of An Open list of random numbers
Concealment
Blinding/Masking Participant Blinded
Primary Outcome Outcome Timepoints
physical and mental growth child After 3 month from the date of enrollment
physical and mental growth of child.
Secondary Outcome Outcome Timepoints
Frequency of common diseases reduces and during study
body immunity increases.
Target Sample Size Total Sample Size=30
Sample Size from India=30
Phase of Trial Phase 3
Date of First 01/04/2015
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=1
Trial Months=3
Days=0
Recruitment Status of Not Applicable
Trial (Global)
Recruitment Status of Open to Recruitment
Trial (India)
Publication Details
Brief Summary The study is A RANDOMIZED CONTROLLED CLINICAL TRIAL ON SWARNA PRASHANA AND
ITS IMMUNOMODULATORY ACTIVITY IN NEONATES. 3 groups taken in this study, first group is
a placebo controlled group, second group Madhu-Ghrita, third group is Swarna-Madhu-Ghrita.
Duration 5 drops daily morning for 6 weeks and follow up period is 8 weeks for each groups.
page 3 / 3
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'A RANDOMIZED CONTROLLED CLINICAL TRIAL ON

SWARNA PRASHANA AND ITS IMMUNOMODULATORY

Thesis submitted as partial fulfillment for the Degree of

Under the supervision of

Dr. V. K. Kori Dr. Rajgopala S.

June - 2016 Enrollment No. - 1654

Prof. K. S. Patel Prof. K. S. Patel

I am extremely happy to express my deepest sense of gratitude to my

I thank all the staff of Pharmaceutical, Microbiology, Pathology, Bio

My profound gratitude to my beloved parents for whom my words fall short.

Dr. Poonam Singh

Ch. Su. CharakaSamhitaSutrasthana

Ch. Sha CharakaSamhitaSharirasthana

Ch. In. CharakaSamhitaIndriyasthana

Ch. Chi. CharakaSamhitaChikitsaSthana

Ch. Si. CharakaSamhitaSiddhisthana

Su. Su. SushrutaSamhitaSutrasthana

Su. Sha SushrutaSamhitaSharirsthana

Su. Chi. SushrutaSamhitaChikitsasthana

Su. Ut. SushrutaSamhitaUttartantra

Chapters Chapter Contents Page No.

Chapter 1 Introduction 01-05

Chapter 2 Conceptual Review

A. Ayurveda Review 06-32

B. Modern Review 33-65

C. Drug Review 66-87

Chapter 3 Analytical Study 88-100

Chapter 4 Clinical Study 101-127

Chapter 5 Discussion 128-167

Chapter 6 Summary and Conclusion 168-171

Annexure I –Informed Consent Form i – ii

Annexure II – Research Proforma --

A Randomized Controlled Clinical Trial On Swarna Prashana and its Immunomodulatory

The procedure to Swarna Prashana as Lehan, is described in Kashyapa

A Randomized Controlled Clinical Trial On Swarna Prashana and its Immunomodulatory

 PREVIOUS RESEARCH WORKS :

1. Jyothy.KB, (2013), “A Randomized Controlled Clinical Trial on Swarna Prashana in

 Aims and Objectives:

The present study is planned with following aims and objectives:

1. To review the concept of Swarna prashana in detail.

A Randomized Controlled Clinical Trial On Swarna Prashana and its Immunomodulatory

1. REVIEW OF LITERATURE: It consists of critical review of the literature

A Randomized Controlled Clinical Trial On Swarna Prashana and its Immunomodulatory

1. World Health Organization Report on Infectious Diseases, “Removing Obstacles to

Academy, Varanasi, 2004, p. 212.

A Randomized Controlled Clinical Trial On Swarna Prashana and its Immunomodulatory

Ayurveda Acharyas. These 16 Samskaras are often referred to as the Shodasa

 Praanpratyagaman (Immidiate care of the New born)-

 If the child is unconscious due to compression of yoni and /or by instruments

 Jatakarma is performed by licking the mixture of honey, Ghrita and powder

d. According to Other authors-

2. Cutting of the umbilical cord.

 Decoction of the Kshiri-vriksha - dominance of Pitta.

 Sarvagandhodaka – dominance of the Vata.

 2nd day- Madhu+Ghrita+Laxmana.

 3rd day - Madhu+Ghrita+Laxmana.

 4th day – Breast milk, butter.22

 Protective measures (Raksha karma):

 Various Rakshoghna drugs like Vacha, Kustha, Hingu, Sarshapa, Atasi,

 Tampon soaked in oil should be applied over head.

c. Measures advised by Vagbhata27

 Administration of Swarna (gold) according to different Acharyas:

Table 2.1: Formulations of gold used in Jatakarma Samskara and later-