Jou?7&al of Ethnophamacology, 29 (1990) 1 - 11 Elsevier Scientific Publishers Ireland Ltd.

AYURVEDIC TREATMENT OF OBESITY: A RANDOMISED DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL

PRAKASH PARANJPEb, PRALHAD PATKI’ and BHUSHAN PATWARDHAN”

“Interdisciplinary School of Ayurvedic Medicine, University of Poona, Pune 411-007, bObesity Clinic, Nanal Hospital, Pune 411-004 and ‘Byramjee Jeejeebhoy Medical College, Pune 411-001 (Indial

(Accepted October 16.1989)

Summary

Seventy obese subjects were randomised into four groups. Ayurvedic drug treatments were given for three months while one group received a placebo. Physical, clinical and pathological investigations were carried out at regular intervals. A significant weight loss was observed in drug therapy groups when compared with the placebo. Body measurements such as skin fold thickness and hip and waist circumferences were significantly decreased. Decreases in serum cholesterol and triglyceride levels were observed. No side effects of any kind were observed during the treatment period.

Introduction

Obesity is an important disorder associated with a number of potentially fatal diseases such as adult-onset diabetes mellitus and ischemic heart disease. Treating obesity has become a problem since safe drugs are not available for long-term therapy. Amphetamines have a well-defined abuse potential and drugs like diethylpropion and fenfluramine cause appreciable undesirable sym- pathomimetic side effects, pulmonary hypertension and depression (Galloway et al., 1984).

Thyroid hormones were once used to treat obesity but are now contraindicated due to their untoward systemic effects (Kyle et al., 1966). There is a clear need for a safer drug for long-term therapy of obesity (Stunkard et al., 1980). The development of a non-toxic compound with a capacity to hold weight gain in check is much needed.

Ayurveda is the ancient science of life. In the Sanskrit language, “Ayu” means life and “Veda” means the knowledge. This branch of medicine has a 5000-year record of use in the Indian system of medicine. The concepts and

Correspondence to: B. Patwardhan.

0378-8741/$04.20 0 1990 Elsevier Scientific Publishers Ireland Ltd. Published and Printed in Ireland

2

treatment of most of the diseases have been described beautifully and in great depth. Ayurvedic classics such as the Charak Samhita and Sushrut Samhita are still followed critically by Ayurvedic physicians in India.

Obesity is referred to as “Medoroga” and is considered to be a disease of “Medadhatu” meaning a disorder of lipid metabolism. A variety of different types have been detailed in the Ayurvedic classics along with the treatment for the same. The basic concepts of obesity according to Ayurveda would be a sepa- rate topic by itself and hence will not be discussed here (Charak Samhita, 19491.

The indigenous drugs described by Ayurveda are comparatively safe and have been used for many years. Drugs such as Triphala guggul, Sinhnad gug- gul, Gokshuradi guggul and Chandraprabha vati are claimed to be effective in the treatment of obesity (Sharangdhar Samhita, 19841 but their effectiveness has not been tested in controlled clinical trials. Therefore, we undertook a ran- domized, double-blind, placebo-controlled clinical trial of these agents in the treatment of obesity.

Materials and methods

A yurvedic medicines Composition of the four formulations are detailed in Table 1 and were

obtained from the well-established company of Ayurved Rasashala of Pune which has a valid drug license issued by the Government. The authenticity of each plant and mineral component was established by the Quality Control Lab- oratory of the company, is also certified by the Government. All tests of identi- fication were carried out by a qualified chemist approved by the Food and Drug Administration.

Clinical studies Seventy subjects referred to the obesity clinic were entered into the trial.

All were at least 20% in excess of their ideal body weight as defined by the Life Insurance Corporation of India’s height and weight recommendations. At the time of entry into the study, they had a stable weight and none was receiving any drug to reduce their weight. All were in good health and biochemically euthyroid and non-diabetic. None of them had any endocrine disorders.

Their characteristics of entry are recorded in Tables 2 and 3. Serum cholesterol was determined using the method of Annan and Isherwood (19691. HDL cholesterol and serum triglycerides were determined by the methods of Chiamori and Henry (19591 and Van Handel et al. (19571. Individuals were div- ided randomly into four groups, namely Group I to Group IV. Treatment was planned according to Ayurvedic concepts and Triphala guggul was given to all patients in all groups except the placebo group (Group III). Other drugs given were Gokshuradi guggul (Group 11, Sinhanad guggul (Group II) and Chandra- prabha vati (Group IV). Individuals in Group III received a 250-mg placebo tablet indistinguishable from the other formulations (Table 1).

The subjects were interviewed individually with respect to diet and exercise

3

TABLE 1

COMPOSITION OF THE AYURVEDIC FORMULATIONS AND PLACEBO

Local name

Scientific name Plant parts Weight per tablet (mgl

Triphala guggul ISharangdhar SamhitaI (250 mg tablet, three times a day, with

lukewarm water before meals) Hirda Terminalia chebula Retz.

(Combretaceael Beheda Terminalia belerica Roxb.

(Combretaceael Amalaki Emblica officinalis Gaertn.

(Euphorbiaceael Pippali Piper longum Linn.

(Piperaceael Guggul Commiphora mukul

Hook ex Stocks (Burseraceael

Gokshuradi guggul (Sharangdhar SamhitcLI (250 mg tablet, three times a day, with lukewarm water, before meals) Gokharu Tm’bulus terrestris Linn.

(Zygophyllaceael Guggul Commiphora mukul

Hook ex Stocks (Burseraceael Shunth Zingiber officinale Roscoe

(Zingiberaceael Mire Piper nigrum Linn.

(Piperaceael Pippali Piper longum Linn.

(Piperaceael Hirda Terminalia chebula Retz.

(Combretaceael Beheda Terminalia belerica Roxb.

(Combretaceael Amalaki Emblica officinalis Gaerth.

(Euphorbiaceael Nagarmotha Cyperus rotundus Linn.

Excipients

Sinhanad guggul (Bhaishaj Ratnawalil (100 mg tablet, three times a day,

with lukewarm water, before meals) Hirda Terminalia chebula

Retz. Kombretaceael Beheda Terminalia belerica

Roxb. (Combretaceael Amalaki Em blica officinalis

Gaertn. (Euphorbiaceael Gandhak Sulphur, purified

Erandsneha Ricinus communis Linn. (Euphorbiaceael

Dried fruit

Dried fruit

Dried Fruit

Dried unripe

fruit

Gum oleoresin

28

28

28

28

138

Dried fruit

Gum oleoresin

Root

Dried unripe fruit

Dried unripe

fruit Dried fruit

Dried fruit

Dried fruit

Rizome

170

35

5

5

5

5

5

5

5 10

Dried fruit 10

Dried fruit 10

Dried fruit 10

(Mineral) 15 Seed oil 40

4

TABLE 1 (continued)

Local

name

Scientific name Plant parts Weight per

tablet (mgl

Guggul Commiphora mukul Hook ex Stocks

(Burseraceael

Chandraprabhavati Kharangdhar Samhital (250 mg tablet, three times a day,

with lukewarm water, before meals)

Vavding

Shunth

Mire

Pippali

Pippalmool

Vekhand

Deodar

Gajapippali

Ativisha

Nagarmotha

Hirda

Beheda

Amalaki

Chavak

Chitrak

Kachora

Kadechirait

Halad

Saindhav

Padelon Jawkhar

Bidlon

Embeliar ribes Burm.

(Myrsinaceael

Z&giber officinale Roscoe (Zingiberaceael

Piper nigrum Linn.

(Piperaceael

Piper longum Linn.

(Piperaceael

Piper longum Linn.

(Piperaceael

Acorus calamus Linn.

(Araceael

Cedrus deodara Roxb., Loud.

(Pinaceael

Scindapsus officinalis Schott. (Araceael

Aconitum he teroph yllum. Wall. (Ranunculaceael

Cyper-us rotundus Linn.

(Cyperaceael

Terminalia chebula Retz. (Combretaceael

Terminalia belerica Roxb.

(Combretaceael Emblica officinalis Gaertn.

(Euphorbiaceael

Piper officinarum Cas D.C.

(Piperaceael

Plumbago teylanica Linn.

(Plumbaginaceael

Curcuma zedoria Rose.

(Zingiberaceael

Swertia chirata Buch Ham.

(Gentianaceael

Curcuma longa Linn.

(Zingiberaceael

Rocksalt, sodium chloride Sodium sulphate

Impure carbonate of potash,

potassium carbonate

Black salt, sodium chloride

Gum oleoresin 15

Dried fruit 1.8

Rizome 1.8

Dried unripe

fruit

Dried unripe

fruit

Root

1.8

1.8

1.8

Rizome 1.8

Stem 1.8

Dried fruit 1.8

Rizome 1.8

Rizome 1.8

Dried fruit 1.8

Dried fruit 1.8

Dried fruit

Stem

Root

Rizome

Stem

Rizome

(Salt) (Salt)

(Salt)

(Salt)

1.8

1.8

1.8

1.8

1.8

1.8

1.8 1.8

1.8

1.8

5

TABLE 1 (continued)

Local name

Scientific name Plant parts Weight per tablet (mgl

Gulvel

Daruhalad

Dhane

Sajjikshar

Dalchini

Elaichi

Tamalpatra

Nishottar

Danti

Vanshalochan

Lohabhasma Khadisakhar Shilajit

Guggul

-

Tinospora cordifolia (Willd.1 Mires. (Menispermaceaei Berberis aristata D.C. (Berberidaceae) Coriandrum sativum Linn. 0Jmbelliferael Impure carbonate of soda, sodium carbonate Cinnamomum ze ylunicum Blume. (Lauraceael Elettaria cardamomum Maton. (Zingiberaceae) Cinnomomum cassia Blume. (Lauraceael Operculina turpethum R.Br. (Convolvulaceael Boliospermum montanum Muell-Arg. (Euphorbiaceael Barn busa arundinacia Willd (Gramineael Ferrous sulphate Sucrose Asphalt Commiphora mukul Hook ex Stocks (Burseraceael Excipients

Placebo tablet (250 mg tablet, three times a day, with lukewarm water, before meals)

Charcoal, I.P. Lactose Excipients

Stem

Rizome

Dried fruit

(Salt)

Stem skin

Dried fruit

Leaves

Root

Root

Gum

(Mineral) (Carbohydrate) (Mineral) Gum oleresin

1.8

1.8

1.8

1.8

7.2

7.2

7.2

7.2

7.2

7.2

14.4 28.8 57.6 57.6

- 1.6

(Carbon) (Carbohydrate)

125 100 25

and were advised suitably. Dietary intake was not controlled. The treatment was continued for a period of three months and patients were examined every two weeks. During these visits their body weight, skinfold thickness, body measurements such as waist and hip circumference, blood pressure, tempera- ture, pulse rate and other clinical examinations were carried out.

Subjective findings such as increased or decreased appetite, feeling of light- ness, sweating, breathlessness, joint pain, etc. were individually noted. Side effects of the drugs, if any, were carefully noted down. On entry and at the end

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of the study, biochemical investigations such as haemogram, urine examina- tions, serum lipoproteins and cholesterol were estimated.

The results were analysed by Student’s t-test.

Results

Forty-eight subjects completed the study and there were 22 dropouts during the course of study. The dropouts were mainly from the placebo group who felt that they were not getting any benefit from the therapy. Ten subjects from the active drug groups dropped out due to a variety of reasons, including domestic and family problems (Table 4).

A significant weight loss was seen in Groups I, II and IV compared to the placebo group. However, weight losses among I, II and IV were not signifi- cantly different from each other (Table 51. None of the patients in the study reported loss of appetite. Skin fold thickness and circumference of the hips and the waistline were significantly decreased as compared to the placebo group P< 0.011.

There was a remarkable reduction in serum cholesterol and triglyceride lev- els in subjects receiving the medicaments as compared to placebo (Table 61. Subjective improvements, such as feelings of well being and lightness and decreased joint pain, appeared to be associated with the non-placebo but could not be statistically documented as significant. Minor side effects like mild diar- rhoea and nausea were observed (8 in the drug therapy groups and 2 in the pla- cebo group) but did not necessitate withdrawal of drug therapy.

Discussion

Obese patients are notorious defaulters (Silverstone and Soloman, 19651. In the present study, efforts were made to retain the interest and co-operation of those taking part in the study and therefore very few defaulted.

In the present study, Ayurvedic drugs were given to an unselected group of obese objects. All three Ayurvedic treatments resulted in significant losses of weight relative to the placebo. It appears that treatment with these drugs can produce a clinically significant weight reduction. The reduction in skin fold thickness and hip and waist circumferences were significantly greater in drug- treated individuals as compared to placebo. The treatment did not produce any significant changes in the pulse rate, body temperature and systolic/diastolic blood pressures, indicating that these drugs do not affect the sympathetic ner- vous system or thyroid function. Although the food intake was not quantitated, drug therapy appeared not to have an anorexient effect.

The exact mechanism of actions of these drugs cannot be ascertained from this study. Whether these drugs affect lipolysis remains to be studied. These drugs decreased serum cholesterol and at the same time increased the levels of HDL cholesterol. Further studies with the individual drug components are warranted.

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The common drug used in these treatments is Triphala guggul. This is a traditional formulation consisting of “Triphala”, a famous mixture of three myrobalans (Terminalia belerica, Terminalia chebula and Embelica officinalis) along with guggul (Commiphora mukul). “Triphala” has high claims in Ayurvedic practice and is in wide use; however, its role as an antiobesity drug remains obscure.

Commiphora mukul seems to be the common ingredient in most of the antiobesity drugs described by Ayurveda. Guggul has been extensively studied for its chemistry (Khanna et al., 1969; Patil et al., 19721, pharmacology (Malho- tra and Ahuja, 1972) and clinical efficacy (Malhotra and Ahuja, 1971). A number of stereoidal compounds has been isolated which have antiinflammatory capac- ity (Arora et al., 1971.1972). Fraction A isolated from guggul was also shown to have antihyperlipidemic activity (Mehta et al., 1968; Das et al., 1973; Nityanand et al., 1973).

Although a definite hypothesis could not be drawn as to the nature of the mechanism of action of these drugs, a definite first step has been taken in the documentation of the ancient concepts of Ayurveda using modern parameters.

Acknowledgements

We thank Dr. P.H. Kulkarni, Chairman, Ayurved Rasashala, Pune, for sponsoring this project. Co-operation from the management of Nanal Hospital is also gratefully acknowledged.

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11

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