Clinical Trial of Homoeopathic Preparations of

Amyleum Nitrosum, Azathioprine, Cocainum

Muriaticum and Cyclosporine in HIV Disease

Dr. V.P. Singh

Central Council for Research in Homoeopathy
New Delhi
Introduction
• Since the presentation of the first cases of
immunodeficiency in homosexual men in 1981 in
New York and California, HIV infection has come
a long way and is currently a Global health
emergency (WHO). It is now the leading cause
of death in most parts of the World and the
fourth biggest killer globally.
By the End of 2006
• 39.5 million people were living with HIV – Globally

• 5.7 million of these were in India

• 11000 new HIV infections reported every day

• 2.9 million people died of AIDS in 2005

• HIV infections increasing among women at a fast

pace
CCRH and HIV
• CCRH undertook a pilot research study in 1989
to ascertain whether homoeopathy can play a
role in the treatment and management of HIV
infection

• The study was undertaken at the RRI, Mumbai

(May, 1989) and CRU, Chennai (October, 1991)
CCRH and HIV
• The results obtained during the pilot study
prompted a randomized placebo controlled study
at Mumbai (1995-97). The results of the study
were published in the British Homeopathic
Journal (1999)
Early Years of Epidemic in India
• In the late 1980s and early 1990s, no ARV drugs
were available in India
• People with HIV were referred to the Council’s
Office at New Delhi for treatment
• All these people were asymptomatic. As such
they were treated on the basis of their
characteristic mental/emotional, physical
attributes
• The treatment also included extensive counseling
and dietary advice
Early Years of Epidemic in
India
Clinical presentation usually comprised of:
• Anxiety about future
• Fear of impending death

This caused:
• Anorexia and Insomnia

Occasionally:
• Diarrhea and weight loss
HIV-Pathogenesis
• HIV causes a slow decline in immune capacity

• The infected person remains asymptomatic

initially
• When his CMI is compromised, he becomes
susceptible to a multitude of opportunist
infections
• Still later develops a clinical state called AIDS
Evolution of New Hypothetical Model
• Based on the analogy that the damage starts at
cellular and molecular level and clinically active
disease develops only when organism stops
responding efficiently to invading microbes WILL
IT HELP ?

• If treatment is aimed at restoring or maintaining

the capacity of T helper cells responsible for
instituting CMI?
Evolution of New Hypothetical Model
• Whether drug substances that are known immune
suppressors in material doses would help if used
in homoeopathic potencies ?

• If they work, how long would their action last ?

• And whether they would work equally well in

asymptomatic and people with intermediary and
advanced stage ?
Evolution of New Hypothetical Model
• These questions prompted a search for such
drug substances which can be tried
• The first one was Amyleum Nitrosum, the
popper which was blamed for immune deficiency
in 1981-82
• Later Cyclosporine and Azathioprine, both used
on people with organic transplants
• Cocaine, another drug which is discredited with
having killer effect on T helper cell and causing
rapid replication of HIV
Objective
An objective was thus evolved which was-
• To clinically evaluate the role of Amyleum
Nitrosum in Asymptomatic infection and to see
whether it could help:

delay the progression of HIV infection and
occurrence of OIs, and
 whether clinical improvement corroborate with
corresponding rise in CD4/CD8 count
Additions of New Medicines for Trial
• Later Cyclosporine, Azathioprine,
and Cocainum Muriaticum were also added to
the list of medicines for trial

• Azathioprine was potentised in 6, 9, 12

potencies initially and later in 30, 200 and 1M
potencies

• Cyclosporine was procured from Ainsworth, UK

in 30CH and raised to 200 CH potency
Methodology
• A study was conducted at New Delhi between
April 1998 and March 2003

• 237 HIV infected individuals including, 96

Females and 8 children less than 10 years of
age were enrolled in the study

• Three of these individuals were suffering from

concurrent Hepatitis B infection and 2 were
reactive to VDRL
Homoeopathic Medicines Used
• Amyleum Nitrosum, Azathioprine,
Cocainum Muriaticum and Cyclosporine were
primarily used as medicines under trial

• Other Homoeopathic medicines were used only

during seasonal minor ailments based on
presenting signs and symptoms.
Other Homoeopathic Medicines Used
• Arsenicum album • Kali bichromicum
• Azadirachta indica • Kali carbonicum
• • Kali Chloricum
Belladonna
• Kali muriaticum
• Borax • Lycopodium clavatum
• Bryonia alba • Mercurius solubilis
• Calcarea carbonicum • Natrum muriaticum
• Carbo animalis • Nitricum acidum
• China officinalis • Nux vomica
• • Pulsatilla
Colocynthis
• Rhus toxicodendron
• Dulcamara • Sepia
• Ficus religiosa • Silicea
• Gelsemium sempervirens
• Hepar sulphuris calc.
Assessment of Outcome
• The response to the treatment was assessed at
the end of the study and was based on the
change in clinical presentation

• The response to treatment was also assessed

by the haematological and immunological
investigations such as CD4/CD8 counts

• Most of these investigations were conducted at

the Council’s HIV Research Laboratory
Assessment of Outcome
• Parameters adopted for Assessment:

Clinical status
 Immunological status
 Quality of life
Response to
Therapy
Asymptomatic stage (At Entry) 149
• Maintaining asymptomatic status 134
• Progress to PGL Stage 02
• Progress to ARC 00
• Progress to Opportunistic infections 05
• Under observation 08
PGL stage (At Entry) 01
• Improvement (became Asymptomatic) 01
Response to Therapy
ARC stage (At Entry) 25
• Improvement 14
• Not improved 04
• Progressed to OIs 05
• Under observation 02

OIs/AIDS (At Entry) 14

• Improvement 07
• Progressed to ARC 01
• No improvement 01
• Under observation 05
Response to Therapy

• Immunological status
– Repeat CD4 + Count 103 cases*
– Increase in CD4 Count 48 cases
– No Change/Drop in CD4 Count 55 cases

* 80 of the cases had presented with CD4

cells <500
 Changes in CD4 Counts
CD4+ T-Lymphocyte Before During treatment
Count treatment

  Total no. Improved Not improved

of cases*

Range T M F T M F T M F

More than 1 - 1 - - - 1 - 1
1000/cumm
Between 500 to 22 6 16 17 4 3 5 2 3
1000/cumm

Between 200 to 62 40 22 25 20 5 37 20 17
500/cumm
Between 100 to 16 7 9 4 2 2 12 5 7
200/cumm
Less that 100 2 1 1 2 1 1 - - -
cells/cumm
Response to Treatment: Symptoms

60
48 46
50 42 42
40 34 32
29 26 pre se nte d
30
20 14 12 Im prove d
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Response to Treatment- Symptoms

18 16 16
16 14
14 12 12
11 11
12 10
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8 Improved
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Observations and Discussion-1
• The results showed that clinical improvement
does not necessarily corroborate with
improvement in CD4 Counts, universally
adopted parameter for the assessment of
effects of therapy
Observations and Discussion-2
• People with HIV and CD4 Counts over 500/cu.mm
respond more favourably at cellular level than
those having lower Counts between 200-500

• However, surprising was that both of the 2

subjects whose CD4 Counts were lower than
100/cu.mm at entry showed increase in CD4
Counts and clinical improvement
Observations and Discussion-
3

• Significant observation was that many subjects

under treatment experienced emotional and
physiological stability despite decline in CD4
Counts
• Another significant observation was that subjects
under study did not develop any opportunist
infections even after 7-8 years of infection
• Most subjects experienced improvement in quality
of life
Observations and Discussion-4
• Only one subject manifested steady rise in CD4
Count over a period of 5 years without any drop

• All other subjects who manifested changes in

CD4 Counts manifested fluctuations, sometime
drop and some time rise in CD4 Count which
can not be explained
Observations and Discussion-5
• Another significant observation was that
candidiasis-oral ulcers, a hall mark of
progressive HIV infection and known to recur
frequently, responded favourably to
homoeopathic therapy
Observations and Discussion-6
• Clinical observation indicate a definite, intricate
relationship between Stress, malnutrition,
sedentary habits and absence of psychological
support from the family and friends and immune
system
• All these factors adversely affect immune
system
• On the other hand removal of one or more or all
these factors was seen to have a salutary effect
on immune system
Conclusion
• It is difficult to make a definitive conclusion as
CD4 estimation facility was not readily available
in the country in 1998 and only 103 subjects had
repeat CD4 Counts

• Another reason for not making a definitive

conclusion is that management of HIV infection
is a complex activity. Medicine alone does not
help people with HIV. There are many other
issues which need to be addressed to
Conclusion
• However, based on the results it can safely be
assumed that:

Specific Homoeopathic medicines which
affect immune system in material doses, can
be used for the treatment of Asymptomatic
HIV infection
 These medicines can also be used in HIV+

people with CD4 Counts over 500/cu.mm with

varying results
New
Studies
• As a logical follow up, CCRH has undertaken two
multicentric studies

– AMulticentric Clinical Trial of Homoeopathic Therapy

in HIV Infection at Mumbai, Chennai, Imphal,
Gudiwada and New Delhi
– A Multicentric Clinical Trial of Homoeopathic
Preparations of Amyleum Nitrosum,
Azathioprine,Cocainum Muriaticum and Cyclosporine
in HIV Infection at New Delhi, Mumbai and Gudiwada
Thank You