LITERATURE REVIEW

1. Overview of diabetes disease burden in India

Diabetes is one of the most prevalent diseases and has become a global health challenge of
this century. People suffering from diabetes have been increasing as a result economic burden
is also increasing on patient and society at large. The increasing disease burden is mainly due
to type 2 diabetes which is more prevalent among patients. The International Diabetes
Federation has estimated that globally there are 415 million people with diabetes in 2015 and
is predicted to increase to 642 million by 2040.1 However 47% of the world’s population is
still undiagnosed for diabetes which is alarming as it will further increase disease burden.
Furthermore, 318 million people are estimated to have impaired glucose tolerance and 20.9
million live births are affected by some form of hyperglycaemia in pregnancy, of which
85.1% are due to gestational diabetes. Diabetic population is increasing in every country, but
more in middle income country such as India, Bangladesh, Bhutan and Indonesia. India
stands at second position among top 10 countries in the world with 69.2 million people with
diabetes and another 36.5 million with pre-diabetes which is a high-risk condition for
diabetes and cardio-vascular disease.1 The increasing disease burden is due to unhealthy
eating habits, lifestyle, genetic conditions and due to lack of awareness.

The South Asian and Pacific region have reported high risk with prevalence of diabetes. The
report also stated notable differences in the characteristics of diabetes in Asian populations2.

In a recently published report by Indian Council of Medical Research (ICMR-INDIAB), a

study was conducted in four different zones of rural and urban India which showed that the
prevalence of diabetes and prediabetes has increased. The inter-state variations in prevalence,
ranging from 4.3% in Bihar, 10.4% in Tamil Nadu and 13.6% in Chandigarh.3

According to a survey conducted in 2012 by National Nutrition Monitoring Bureau among

the rural population showed 8.2% and 6.8% among adult men and women for diabetes,
respectively. The disease burden was reported to be high states of Kerala, Tamil Nadu and
Gujarat among both genders. Analysis also showed increase in diabetes prevalence among
rural population at a rate of 2.02 per 1000 population per year.4

Epidemiological studies carried out by India Diabetes Research Foundation in Southern

Indian population showed an increase in prevalence of diabetes and prediabtes in city and
rural population. The diabetes prevalence was 5% in 1985, 8.2% in 1989, 11.6% in 1995,
13.9% in 2000 and 18.6% in 2006 in City. The prevalence of diabetes in rural population was
2.2% in 1989, 5.9% in 2000, 6.4% in 2003 and 9.2% in 2006.5-11

Prevalence of diabetes among children is also increasing at the rate of 3% (Type 1) every
year. In 2015 the number of children worldwide with type 1 diabetes exceeded half a million
for the first time. There are 70,000 children suffering from this condition alone in India,
1
making it second largest in the world after USA. Gestational diabetes poses higher risk
among women and long-term consequences for the offspring.

Diabetes is a disease which causes many complications in long run like retinopathy,
neuropathy, nephropathy and peripheral vascular diseases. However cardiovascular diseases
are one of the leading causes of death among people with diabetes.

Health care cost is also one of the major reason of increasing prevalence of diabetes. In India
around 85-95% of all health care cost are borne by individuals and their families from
household income. Direct expenses consume 27–34% of household incomes of rural and
urban poor people while the middle-to-high income groups in rural and urban areas consume
5.0–12.6% and 4.8–16.9% of income respectively on diabetes care.12,13

In the Grover et al. study, the total annual cost of care for a sample population of 50 patients
was 14,508 rupees (263.78 euros). The largest proportion of the total cost was made up of
direct costs (68%), followed by indirect costs (28.76%) and provider’s costs (2.8%). Drug
costs were high. Total treatment cost was seen to be higher among educated population, those
receiving a greater number of drugs and those who visited the hospital frequently.13,14

A study in Indian patients by Ramachandran et al analyzed the urban-rural expenditure on

diabetes. The study indicated that the economic burden of diabetes care on families in
developing countries is rising rapidly, even after accounting for the inflation. The annual
family income was higher in urban subjects [rupees (Rs) 100,000 or $2,273] than in the rural
subjects (Rs 36,000 or $818) (P < 0.001). Total median expenditure on health care was Rs
10,000 ($227) in urban and Rs 6,260 ($142) in rural (P0.001) subjects. Treatment costs
increased with duration of diabetes, presence of complications, hospitalization, surgery,
insulin therapy and urban setting. For example, expenditure proportionately increased with
the number of complications. Expenditure on treatment of complications varied significantly
between the populations.13,15
According to Cost of Diabetes in India (CODI) study, which was a large community based
survey of diabetes costs, ambulatory care constitutes 65% cost whereas hospitalization cost is
35%. It was observed that therapy cost is 31% of which specific antidiabetic drug cost is only
17%. Ambulatory care including monitoring and doctor visits constitute 34% costs.13,16

The Delhi Diabetes Community (DEDICOM) study by Kumar et al. analyzed the direct cost
of ambulatory diabetes care among the middle and high income group diabetics in the capital
city of Delhi. The average estimate of direct annual expenditure on ambulatory care of
diabetes was ~ Rs 6,000 (~US$ 150).13,17

2. Healthcare infrastructure for diabetes in India

In India, more than 7.8% of the population is affected by diabetes, of which more than 30
million are undiagnosed or untreated, thus increasing the risk of developing complications
and premature mortality.

Hence it is a challenge to increase awareness regarding this disease among general

population. There is a strong need of innovative technologies which will increase health
literacy and services among the general population and high risk groups, while also
improving management and quality of life in confirmed diabetics.

As India is moving rapidly towards digitalization and with high mobile high penetration of
mobile communications in India, it is easier to deliver healthcare services through mobile
phones.Therefore, the Ministry of Health and Family Welfare (MoHFW) in collaboration
with the WHO Country Office for India and other partners, has launched a mobile health
initiative for the prevention and care of diabetes – mDiabetes.

mDiabetes is launched with the aim of improving awareness about diabetes and promoting
healthy diets and active lifestyle, which is considered necessary for the prevention of
diabetes. It will also help in early diagnosis, dietary control, self care, as well as prevention of
complications among patients with diabetes.18

NGO like Diabetes India has also launched an initiative called Diabetes-free India by 2030
which is supported by Diabetes Care India’, founded by Gujarat-based diabetologist. The
campaign aims at ensuring that all the children born after the year 2030 to be free from
diabetes, for which stakeholders like doctors and schools need engage and work together to
ensure a diabetic free nation.19

National Diabetes Control Programme also launched a pilot project year in 1987 in some
districts of Tamil Nadu, J & K and Karnataka.20

The objectives of the programme were:20

 prevention of diabetes through identification of high-risk subjects and early

intervention in the form of health education;

 early diagnosis of disease and appropriate treatment; reduction of morbidity and

mortality with reference to the high-risk group;

 prevention of acute and chronic metabolic, cardiovascular, renal and ocular

complications of the disease;

 provision of equal opportunities for physical attainment and scholastic achievement

for the diabetic patients; and

 rehabilitation of those partially or totally handicapped diabetes people.

Healthy-India.org, was another positive step taken by the Ministry of Health and Family
Welfare and the Public Health Foundation of India (PHFI), which educates people about
healthy living, prevention of diabetes and other non-communicable diseases. The Integrated
Disease Surveillance (IDS) programme analyses chronic disease risk factors and could be
improved to obtain data more frequently and systematically using high- quality methods.

The Ministry of Health spearheaded a national consultation in 2005 to identify action

pathways and partnerships for implementing the Global Strategy in the context of India. In
order to contain the increasing burden of Non-Communicable Diseases, Ministry of Health
and Family welfare, Government of India, had launched the National Programme on
Prevention and Control of Diabetes, Cardiovascular diseases and Stroke (NPDCS) on
8th January 2008 with the following objectives:

Objectives of NPDCS:21

 Prevention and control of NCDs.

  Awareness generation on lifestyle changes.

 Early detection of NCDs.

 Capacity building of health systems to tackle NCDs.

In a study conducted by Raghupathy et al. , in which 11 cities across 9 states were selected
where public and private diabetic care providers were identified. Both multispecialty and
standalone diabetic care facilities were included. Physician in 73 hospitals were interviewed.

According to the survey about 74% had provision for glycated hemoglobin testing. Printed
protocols on management of diabetes were available only in 31.5% of the facilities and only
one in four facilities had a system for tracking diabetics.

The number of endocrinologists was also significantly higher in multispecialty hospitals and
in larger cities. This documents the fact that specialists tend to aggregate in facilities with
better infrastructure.

It was also observed that general physicians were generally managing diabetic care, which is
consistent with what has been reported from India earlier. In a pan Indian study, 70% of
diabetics were diagnosed by general physicians rather than specialized endocrinologists or
diabetologists.22

Teaching institutes, public-funded institutes, and multispecialty hospitals tended to have a

significantly greater number of general physicians and residents. Again this reflects
inequitable distribution of health care delivery and human resources in the country.

Treating hyperlipidemia and proteinuria in diabetics is a very important aspect of

management of diabetes, to reduce the risk of complications like diabetic retinopathy. In our
study, it was observed that more than 80% of institutions assessed possessed the capability of
testing for lipids.

Diabetic kidney disease is one of the most common causes of end stage renal disease. 23 It is
present in approximately 40% of patients with type 2 diabetes. Approximately, 85% of
institutions in the present study had the capability to perform renal function tests.

Thus, a majority of institutions could perform the basic, necessary tests to diagnose and
manage diabetes. However, public-funded institutions would need to consider introducing
tests for HbA1c to detect diabetes among their client population.
A majority of institutes also had a pharmacy attached, which distributed drugs for diabetes.
All public-funded institutions had this facility, whereas 76.1% of the private institutions did.
Having attached pharmacies would not just be convenient, but would also played an
additional complementary role as the pharmacists can be effective “counsellors.” Studies
have also shown that counseling by pharmacists reduces the level of postprandial blood
glucose, triglycerides and LDL.24

Hence there is a need of improved healthcare infrastructure to reduce prevalence of diabetes.

Clinical Evidence for AYUSH therapies for diabetes

Diabetes mellitus is a disorder characterized by insulin deficiency, increase in the glycaemic

levels and insulin resistance. Ayurveda literatures provide the pathogenesis, management and
complications of disease which is said to have scientific mutual relationship with the lifestyle,
diet and genetic factors. The treatment in Ayurveda provided based on the stage and life of
the person. Thus Ayurveda is also called person centric management. Furthermore many
classical references to use dosage forms of single plant drugs and compound formulations,
which are vogue in clinical practice call for further scientific validation for their attributes,
principles and extent of use. Despite the latest progression in the field of modern medicine
some fields are still unexplored and requires special attention. Ayurveda serves to provide
safe and effective approaches for management of such conditions. Despite the number of
challenges there have been number of clinical studies conducted to provide scientific
evidence of the safety aspects25.

In Ayurveda diabetes falls under the term Madhumeha. Thus there are number of herbal
preparations like decoctions, juices and powders for treatment of diabetes. All of these are of
plant origin thus do not contain any adverse effects in therapeutic doses. However they may
contain animal and inorganic products26.

Experimental and Clinical trials

Aagles marmaleos( holy fruit tree)

There has been several biochemical studies carried on streptozotocin induced diabetic rats
that proved that the aqueous extract of Aegle marmelos had antiglycaemic activity. Two
varieties of ethanol extract of bitter and sweet Bilva leaves were given to the albino rats. Both
exhibited a dose dependent decrease in hypoglycemic activity.Sweet bila leaves showed
decrease in blood glucose level activity at 6 hours whereas the bitter one showed at 8 hours
and continued upto 24 hrs27.

Oral administration of this extract was seen to reduce the fasting blood glucose level by
60.84% for 14 days. Moreover in normal healthy rats it could bring down the sugar level by
35% and by 42% in mild diabetic rats.It could overall decrease the Level of cholesterol with
significant increase in HDL and decrease in triglycerides.Aqeous extract of seed was
scientifically proven to have antidiabetic activity27.

Coccinia indica (Bimba)

C.indica has scientific evidence for lowering of hypoglycemic effect.A decrease in blood
glucose level by 27mg% in streptozotocin induced diabetic rats as compared normal rats.The
authors suggest this due to the effect of enzymes hepatic glucose-6-biphosphates enzymes.
The clinical study says that this extract acts very similar to that of insulin in terms of its
action by decreasing glucose-6-phosphatase and lactate dehydrogenase (LDH) levels in
glycolytic pathways. In a double-blinded controlled trial, the leaves of C. indica also
improved glucose tolerance in patients with uncontrolled type 2 diabetes. Out of 16 patients,
10 of them showed significant improvement in blood glucose level (Azad Khan et al.,
1979)28.

A controlled trial was done using the tablets obtained form the aqeous extract of the herbit
was administered twice daily for 3 months before meal.The drug led to decrease in lipid
fraction by providing a normal range for control of hyperglyemia.

Tinospora cordifolia (Tinspora)

Tinspora is known to have hypoglycaemic, and hypolipidemic effect. It acts by bringing

down the hypoglycaemic action by increasing the secretion of insulin by the pancreas. It
causes an effect on the hexokinase activity and decreases the activity of hepatic glucose-6-
phopshatase in diabetic rats. Gupta et al. (1967) showed that aqueous and alcoholic extract of
this plant increases glucose tolerance in albino rats. In another study a significant reduction
was observed in mean fasting blood glucose by approximately 128 mg% and by
approximately 130 mg% on administration to alloxan induced diabetic rats. Plasma
concentration of TBRAS, ceruloplasmin, and alpha-tocopherol increases in diabetic rats due
to increased lipid peroxides. These researchers reported that root extract of this plant
decreases the elevated levels of ceruloplasmin, alpha-tocopherol, and TBRAS in diabetic
rats29.

Momordica charantia (Karavellaka).

Both experimental and clinical trials carried out revealed that aqueous extract had anti
diabetic properties and adapt genic effect. The extract was found to be more effective than the
fruit. The difference in terms of weights, glucose and triglyceride levels was seen in fructose
feed rats. The aqueous extract led to decrease in insulin levels for 15 days. This is because it
facilitates the regeneration of the pancreatic beta cells for secretion of insulin30.

Clinical trials have shown that it led to enhanced dehydrogenase activity, resulting in
decreased synthesis and increased oxidation of glucose leading to lowered glucose levels. It
has been suggested that the inhibition of glucose uptake from the intestine may be an
important factor in lowering the BGL by MC. Two important constituents isolated from the
plant showed dose response effect in inhibition of blood glucose levels31.

An insulin like compound was isolated from the MC was delivered by injection to 8 male and
1 female patient and to 5 control healthy control subjects of the same age for a period of 3
months. The compound thus produced hypoglycaemic effect in both type 1 and 2 patient10.

In another study a powder was administered twice a day for 7 days to only type 2 diabetic
patients and significant hypglycemic effect was thus seen.Thus from the above studies we can
conclude that the drug provides sufficient clinical evidence for use in diabetes.

Vijayasara (Pterocarpus marsupium) in NIDDM:

Pterocarpus marsupium in India is a moderate to large tree. The extract of the tree is used to
diabetes. This wood is known for its hypoglycaemic activity .This wood contains an
important ingredient called epicatechin which showed decrease in sugar level in rats within
24 hours of administration. Moreover the three phenolic constituents were isolated and
studied for their hypoglycaemic activity32.

Ethanolic extract of P.marsupuim was administered to alloxan induced rats could decrease
the blood sugar levels by increasing the secretion of insulin.However the overall effect led to
cataract development was assessed. However further study indicated that the administration
of extract led to decrease in blood glucose and was favourable for management of body
weight34.

The Indian Council of Medical Research evaluated the effectiveness of the PM in type II
diabetes. The study was carried out in 98 patients out of which 93 were given the extract of
PM for period of 12 weeks.The fasting blood glucose levels fell significantly to 151mg/day
from 216mg/day. An open trial was carried out in four centers in India to study the efficacy of
the Pterocarpus marsapium in treatment of non-insulin dependent diabetes management.
Control of blood sugar levels were seen in 69% of the patients35.
Gymnema (Gymnema sylvestre )

Gymnema (Gymnema sylvestre ), also known as periploca of woods in the Asclepediaceae

family is a large woody and branched fiber.Number of experimental study has been carried
out states that aqeous extract showed improved glucose tolerance in diabetic induced
rats.Many experimental and clinical studies have documented the hypoglycemic action of this
plant. One of the clinical study indicated that the extract when administered as an adjuvant
therapy to oral hypoglycaemics led to significant reduction by 50%mg in 18 month in
subjects who received the extract. Further the dosage was reduced to prevent
hypoglycaemia.Five (5) of 22 patients were able to discontinue their conventional oral
hypoglycemic agents and blood-glucose homeostasis was maintained by GS4 extract alone.
Significant reduction in plasma lipid levels was also observed, suggesting hypolipidemic
effect of this plant36 .

In another study of patients with type 1 diabetes, GS4 extract was administered to 27 patients
along with insulin for the periods ranging from 2–30 months, compared to 37 controls
receiving insulin only.

It was observed that insulin dosage had to be reduced by approximately 25% after 6– 8
months and by approximately 50% after 26–30 months, respectively, while mean fasting
blood glucose level reduced considerably. Reductions in serum amylase, lipids and HbA1c
levels were also observed by GS4 extract. Serum Cpeptide levels were also increased after
supplementation of leaf extract, suggesting an increase in beta cell function . Water-soluble
extracts (GS3 and GS4) obtained from leaves release insulin probably by causing
regeneration of pancreatic beta cells both in vivo and in vitro37.

It acts by the following mechanisms for its hypoglycemic effect:

1. Increased secretion of insulin- to stimulate the invitro release.

2. Protection of pancrease from chemical toxins –It promotes the regeneration of

pancreatic cells and has a protective effect on the pancreas.

3. Increased utilization of insulin-increase the activities of enzymes responsible for

utilization of glucose.

4. Inhibition of glucose absorption from the intestine.

Curcuma longa (Ivy guard)

In Ayurveda, C. longais advocated extensively for the treatment of diabetes but few scientific
studies are available in the modern literature. Curcumin, an active ingredient isolated from C.
longa, has been shown to have hypoglycemic, hypolipidemic, and antioxidants effect in
experimental studies. Recently, it was reported that curcumin decreases blood glucose, HbA
1c in diabetic rats. In addition, curcumin also decreased oxidative stress in diabetic rats. It
was found that the levels of thiobarbituric acid reactive substance (TBRAS) decrease after
supplementation of curcumin. They hypothesized that it may be the result of decreased influx
of glucose in polyol pathway, thereby increasing NADPH/NADP ratio and increased activity
of glucose peroxidase enzyme38.

The beneficial effect of curcumin has been suggested in diabetic dyslipidemia, without
altering the hyperglycemic status in diabetic rats. Babu et al. (1997) observed a significant
reduction in blood cholesterol in curcumin fed diabetic rats and this reduction was
exclusively from LDL very low density lipoprotein (VLDL) fraction. A significant reduction
in serum triglycerides and phospholipids were also observed. Curcumin also increase the
activity of b-hydroxy-b-methylglutaryl-coenzyme A (HMG-CoA) reductase and hepatic
cholesterol-7 a-hydroxylase enzymes in diabetic rat livers. It was reported that
hypercholesterolemia may possess an additive risk factor that determines the rate of decline
in kidney function in diabetes. They observed that patients with diabetic nephropathy and
high serum cholesterol levels exhibit higher degrees of renal lesion (Mulec et al., 1990).
Excretion of larger amounts of proteins of higher molecular weight and renal tubular enzymes
is associated with diabeticnephropathy. It was observed that the diabetic animals fed on
curcumin diet reduced excretion of these proteins and urinary enzymes than control diet fed
rats significantly (Suresh Babu and Srinivasan, 1998). Same group of investigators (Suresh
Baba and Srinivasan, 1995) have been reported previously that curcumin-fed diabetic rats
excreted comparatively lower amounts of albumin, urea, creatinine, and inorganic
phosphorus. These observations led to the hypothesis that curcumin ameliorates the early
renal lesions associated with diabetes, as a result of its cholesterol-lowering ability without
altering hyperglycemic status (Suresh Babu and Srinivasan, 1998)39.
Clinical trials on Combination therapy :

Ayush 82: Ayush 82 is formulated and clinically proven by Central Council Research in
Ayurveda Sciences, M/o of AYUSH, GOI for diabetic care. Recently Right Sugar
(Chaturbhuj Pharmaceutical), IME-9 (Kudos Ayurveda) and BGR-34 (AIMIL
Pharmaceutical) have drawn the attention of many diabetic consumers as these products are
developed from scientific organizations of government and highlighted in electronic and print
media. IME-9 (Kudos Ayurveda) developed from Ayush 82 of Central Council Research in
Ayurveda Sciences, M/o of AYUSH, GOI. Most of the patients consuming IME-9 attend
Ayurvedic hospitals and clinics for evaluation of their blood sugar level to know the efficacy
of the drug and for consultation. Therefore, an initiative was taken to analyze the safety and
efficacy of IME-9 in newly diagnosed diabetic patients taking an IME-9 tablet or have a
primary prescription of the same. IME-9 was able to reduce (96%) the blood glucose of all
newly diagnosed cases, whereas glycosylated haemoglobin level was reduced in all newly
diagnosed cases except in one. Total 12 (48%) patients have shown the improvement of blood
glucose and glycosylated haemoglobin (up to 7). It is also observed that in three cases blood
glucose level was increased after 2 weeks of treatment and significant reduction of blood
glucose was found after the 8th week. So IME-9 may be the first line choice of herbal
treatment of newly diagnosed cases along with a change in lifestyle41.

BGR-34: The drug has been developed jointly by scientist of National Botanical Research
Institute (NBRI) and Central Institute for Medicinal & Aromatic Plants (CIMAP), the
Lucknow, India-based research units of CSIR. Scientists of NBRI and CIMAP made an in-
depth study on 500 anti-diabetic herbs from ancient literature of Indian System of Medicine
Ayurveda (Caraka Samhita, Sushruta Samhita, Astanga Hridaya and Bhavprakash) and finally
identified the six herbs (Berberis aristata, Tinospora cordifolia, Pterocarpus marsupium,
Gymnema sylvestre, Rubia cordifoila and Trigonella foenumgraecum). Pre-clinical studies
conducted by CSIR on BGR-34 produced encouraging results in diabetes induced
experimental subjects (unpublished data CSIR). Encouraged by the preclinical outcome,
CSIR moved to investigate the active components from BGR-34 and we moved to test its
clinical efficacy, with an aim to ensure the scientific validity, efficacy and safety of BGR-34
on blood glucose regulation with type-2 diabetes mellitus based on clinical studies.
A double blind placebo controlled clinical study of BGR-34 in patients with type-2 DM was
approved by the independent human ethics committee of Aggarwal Dharmarth Hospital, New
Delhi, India.BGR-34, showed promising result with respect to glycemic parameters in patient
with type-2 diabetes with significant reduction in fasting blood sugar by 34.3%, post prandial
blood sugar by 35.5% and glycosylated hemoglobin by 20.31% as compared to placebo
group showing reduction by 13.2%, 10.9% and 10.87%, respectively. The trial has also been
registered to CTRI, India. BGR 34 has been investigated to contain a number of active
biomolecule molecules including the compound berberine (Berberis aristata), a natural
dipeptidyl peptidase IV (DPP-4) inhibitor, that act by increasing endogenous GLP-1 and GIP
concentrations. Via this mechanism, insulin secretion is glucose-dependently stimulated and
glucagon secretion inhibited.

Ayurvedic Therapy in Diabetes Retinopathy: A Combination of therapy viz.tarpana with

Patoladi ghrita and internal administration of Dhanvantara Kwatha 20ml, Punarnavasava
25ml, Candraprabhavati 250mg and Nisamalaki 5 gm twice a day in the subjects of Diabetes
retinopathy showed remarkable improvement in visual acuity. There was no further visual
loss, no further focal haemorrhages and no neovascularisation was observed (Srikanth, 2005).

Nishamalaki : An open clinical trials wherein 100 patients were subjected to the drug
nishamalaki for studying the effectiveness in NIDDM. The drug was given twice daily with
water for 6 weeks. The results showed that the drug has got moderately good hypoglycemic
effect .

Amrita-Pippali-Nimba Yoga : A series of 50 patients of diabetes mellitus divided into three

groups Group A (n=15): Amrita-Pippali-Nimba Yoga; Group B (n=14): Add on therapy for
the drug C(n=8): Placebo were studied .The Amrta-Pippali-Nimba Yoga has showed
significant improvement in both fasting and postprandial blood sugar levels in both the
groups when compared to placebo.

Glucocare capsules : Another study was conducted to evaluate the safety and efficacy of
Glucocare Capsule an ayurvedic formulation in diabetes mellitus.50 patients were selected
and divided in two groups , glucocare and placebo respectively .All received the dose for 3
months before meals of 2 capsules daily. All the 50 patients successfully completed the trials-
with no dropoust or withdrawal. The formulation was well tolerated and contributed to
significant decrease in the glucose levels respectively. The study indicates clinical efficacy of
GlucoCare Capsules in the management of NIDDM in those belonging to pitta-kapha
prakriti. The formulation is well tolerated and appears safe in the dosage used42.

The review of literature indicates that the concept of DM and the herbs used have found to
have a significant effect on animal models. This makes AYUSH a considerable choice as an
antidiabetic therapy which is safe and effective.

Ayush Formulations for Diabetes

Diabetes is the most widespread disease in India. Recently, the survey was published which
shows that more than 62 m individuals diagnosed with the disease. According to a report,
Oral hypoglycemic agents and herbs are concomitantly being taken by more than 50%
diabetic patient while only 5% diabetic patients consult ayurvedic doctors before starting off
any herbal medicine for diabetes. Ayush formulations are normally made up of natural
sources which are not harmful to any patient. Therefore, diabetic patients buy ayurvedic
medicines by teleshopping, online shopping and on phone call and they start off taking
Ayurveda medicines along with allopathy medicines that is not good for their health.[42,43]

There are some ayush formulations available for the treatment of diabetes in the market,
Such as, Ayush-83, IME-9, BGR-34, Right Sugar etc. Polyherbal formulation called Ayush-
82 has been developed for the treatment of diabetes mellitus by CCRAS (Central Council for
Research in Ayurvedic Sciences).[43,44]

Drug Profile (Ayush-82) [45]

 Sr. No. Drug Name Botanical Name Part used
Syzygium cumini (L.,)
1. Jambu Seed
Skel
Momordica
2. Karvellaka Seed
charantia Linn.
Gymnema sylvestra
3. Meshashringi Leaf
R. Br.
Mangifera induce
4. Amra Seed
Linn.

Recommended Dose

15 g per day in 3 divided doses along with 500 mg Shuddha Shilajita twice daily3, 4.

BGR-34

BGR-34 is the most studied and clinically approved drug amongst all the available herbal
agents against diabetes. It is basically made up of plant extracts and CSIR has developed this
drug. BGR-34 is refined along with 34 crucial phytoconstituent extracts and derivatives
according to healing principles of Ayurveda. It transforms proinsulin to insulin by that
increasing the amount of active functional insulin units. Glucose homeostasis is regulated by
reducing blood glucose synthesis and great utilization of excess glucose.[46]

There are such anti diabetic herbs in siddha medicines which are utilized in the treatment of
diabetes mellitus such as, seed of Trigonella foenum- gracecum, the stem juice of Tinospora
cordifolia and Terminalia arjuna etc.[6] Syzyguim jambolanum is broadly utilized in
homeopathy for treating patients having diabetes mellitus. Significantly, it reduces fasting
blood glucose levels.[7]

Glucocare (180 Vegetarian Capsules):- [47]

Glucocare is a product of Himalaya Herbal Healthcare and used in the treatment of diabetes.

GlucoCare is made up of natural sources and it does not contain dairy products, wheat, yeast,
preservatives, corn or ingredients of animal origin. It supports the beta cells of the pancreas
that help to store and release sugar. Adults can take 2 capsules twice a day before meal.

Dabur Madhu Rakshak [48]

It is a combination of antioxidant, anti-diabetic immune modulator plants and minerals which

deliver complete safety from diabetes and its complications.
Dosage:
To be taken 1-2 tea spoonful twice a day with water as directed by the physician or before
meals.

Uses of Madhu Rakshak:

 As an adjuvant in diabetes.
 In the case of diabetic complications.
 To improve the overall quality of life of a diabetic patient.
 It helps to reduce craving for sweet

Divya Madhunashi Vati:-[10]

This is a very effective herbal drug to naturally control diabetes. It is a product of Patanjali
(Divya Pharmacy). It aids to achieve good control over blood sugar levels and increase
secretion of insulin from pancreas.

Dosage:

1-2 tablets twice daily.

Uses:

This medicine helps in activating the pancreas to secrete an equal amount of insulin and
additional amount of glucose is converted into glycogen.

Prescribing guidelines for diabetes by MCI and diabetes bodies

Prescription guidelines or Good Prescription Practices needed to be developed and circulated

amongst all Ayurveda practitioners. The guidelines must include the details like,
1) Maximum duration of a certain formulation can constantly be prescribed.

2.) Information regarding safety of a formulation in case of different groups of patients such
as, pregnant women, pediatric population, lactating women and geriatric age etc.

3.) The complete procedure of acute/chronic toxicity of the certain antidotes, formulations,
doses and their route of administration etc.

4.) Procedure to report the toxicity related cases to the pharmacovigilance department.
Moreover, it has to be made compulsory for any prescription to mention the all relevant
details.

5.) A certain requirements for an independent pharmacovigilance department at every Ayush

college and hospital must be encompassed in the requirements.[49]

6.) Review, highlight instruction on lifestyle, diet and adherence to the treatment of drug at
each and every step.

7.) Gauge HbA1c levels at 3/6 monthly intervals and boost them to maintain it. Always be
aware of possible reasons for low HbA1c levels.[50]

Management of Type-2 Diabetes (NICE Guidelines)[53]

Ref:- Adapted from NICE Clinical Guideline 28 (December 2015; updated May 2017) – Type
2 diabetes in adults: management.

Insulin based treatment:[12]

 Continue metformin if tolerated, Review continued need for other hypoglycaemics.

 Offer NPH insulin once or twice daily according to nee.
 Consider starting both NPH + short acting insulin, separately or as biphasic human
insulin (particularly if HbA1c ≥75mmol/mol (9%); consider biphasic preparations
containing a short-acting insulin analogue if person prefers injecting immediately
before a meal, hyperglycaemia is a problem or blood glucose levels rise markedly
after meals).
Alternative to NPH insulin:[54]
  Insulin detemir or glargine if assistance is needed to inject insulin, lifestyle
constrained by recurrent symptomatic hypoglycaemia or would otherwise need
twice daily NPH insulin + oral hypoglycaemic.
 Offer insulin + GLP-1 agonist only with specialist advice and consultant led
multidisciplinary support.
 An SGLT2 inhibitor + insulin +/- other antidiabetic drugs is an option.

ICMR Guidelines for Management of Type-2 Diabetes

Symptoms of diabetic person:-

Spontaneous Plasma glucose level ≥ 200 mg/dl

Fasting plasma glucose ≥ 126 mg/dl

2 hour post 75 g glucose ≥ 200 mg/dl

Positive test should be established with another test consequently.

The diagnosis of Diabetes and Glucose Intolerance Criteria are as follow:[13]

Normoglycemia IFG or IGT Diabetes

FPG ≥110 and <126 mg/dl
FPG < 110 mg/dl FPG ≥126 mg/dl
(IFG)
2-h PG ≥200 mg/dl
symptoms of diabetes
2-h PG ≥140 and <200 mg/dl
2-h PG <140mg/dl and casual plasma
(IGT)
glucose concentration
≥200 mg/dl.

Ref:- ICMR Guidelines for Management of Type-2 Diabetes, Section-3.

Where,

IFG- Impaired Fasting Glucose FPG- Fasting Plasma Glucose

 IGT- Impaired Glucose Tolerance 2-h PG- 2 hour post load Glucose test plasma
glucose

Test for Oral Glucose Tolerance [13]

 The person who is going to be tested must be on a normal diet for minimum 3
days before the test.
 The test should be done after an overnight fast of 8-10 hours and comprises of
two blood samples: before meal and 2 hours after meal.
 The person should be resting and refrain from smoking in between the two
sample collection.
Retesting Criteria for Diabetes in Asymptomatic High Risk Individuals

 Undiagnosed high risk individuals with normal test – retest yearly or once in 2
years.
 Impaired Glucose Tolerance, Impaired fasting glucose.
Testing criteria for Type – 2Diabetes in Children and Adolescents

Overweight (weight.120% of ideal body weight) plus any of the following risk factors:

 Family history of type-2 diabetes in first or second degree relative.

 Signs of insulin resistance or conditions which are associated with insulin
resistance (Acanthosis nigricans, hypertension, dyslipidemia or PCOS).