Journal of Pharmacy Research Vol.2.Issue 5.May 2009

Avnish K. Upadhyay et al. / Journal of Pharmacy Research 2009, 2(5),897-899Research ArticleISSN: 0974-6943

*1Upadhyay; Avnish K, Kumar Kaushal2 ,Mishra Harishankar3

1 DYMT (SIROs), Patanjali Yogpeeth, Haridwar. 2 Patanjali Herbal Garden & Agrotech Department, DYMT (SIROs), Patanjali Yogpeeth, Haridwar.

3Deptt. of Dravya-guna, Govt. Ayurvedic College, Gurukul Kangri, Haridwar.Received on: 30-09-2008; Accepted on: 25-02-2009

ABSTRACTThis preliminary clinical study was conducted to evaluate the effect of combination of Shilajit extract and Ashwagandha (Withania somnifera)on fasting blood sugar and lipid profile subjects with early diagnosed type-II diabetes (NIDDM). At the onset of treatment baselineassessment was taken following General symptomatic examination, Average Fasting Blood sugar and lipid profile. The patients were in-structed to take investigational combination twice a day for four weeks. At the end of the therapy period, it was found that the drug hadconsiderably reduced symptoms related to diabetes, average fasting blood sugar and lipid profile.

Keywords: Ashwagandha, Shilajit, Average Fasting sugar, Lipid profile

*Corresponding author. Tel:01334-240008 Extn: 1312, 1221Telefax: +91-09410561733 E-mail: avnishdr@yahoo.co.in

INTRODUCTION

Diabetes, long considered a disease of minor significance toworld health, is now emerging as one of the main threats to humanhealth in the 21st century1 not only in developed nations but also indeveloping countries where non-communicable diseases are rapidlyovertaking communicable diseases as the commonest cause of death.Recent World Health Organization (WHO) projections suggest thatin the next two decades, the largest increase of diabetes will be seenin the economically productive age group i.e. 20 – 45 year old indi-viduals in developing countries2. With its population over 1 billion,India leads the world with its largest number of diabetic subjects(over 35 million) 2-4 and this number is predicted to increase to around80 million by the year 20302.

In the early 70’s prevalence of diabetes was 2.3% in theurban and 1.5% in the rural India5. Recent studies have reported ahigh prevalence of diabetes between 12-16 % in the urban populationand 4-6% of the rural population of India6. Thus, diabetes has be-come a great medical and health economic challenge as it drains be-tween 5 – 25 % of the family income of an average Indian, whichtranslates to 2.2 billion US dollars per annum7.

Diabetes mellitus was known to ancient Indian physiciansas ‘Madhumeha’. Since, so many herbal products including severalmetals and minerals have been described for the care of Diabetesmellitus in ancient literature8. Ayurveda has been the first to give an

elaborate description of this disease, its clinical features and the pat-terns, and its management by herbal or herbomineral drugs. It is seenthat certain resistant cases of diabetes who do not respond well tomodern medicines like Chlorpropamide, Tolbutamide and Glibenclamiderespond very well when treated with herbal preparations, alone or incombination with other oral hypoglycemic agents. Herbs have beenshown to have hypoglycemic action in animals and humans9-11.

Non-insulin-dependent diabetes mellitus is among the mostcommon disorders in developed and developing countries. It amountsfor about 85% of diabetes world-wide and is associated with enor-mous amount of morbidity and mortality resulting from its micro vas-cular and macro vascular complications12.

The treatment of hyperglycemia in NIDDM is aimed at allevi-ating the symptoms, increasing the sense of well being and the qual-ity of life with minimizing the chronic complications. Oralhypoglycaemic drugs play an important role in the treatment of noninsulin-dependent diabetes mellitus. But none have been unequivo-cally successful in maintaining euglycaemia and in avoiding late com-plications of diabetes. In spite of several advances in therapeuticsand detailed understanding of the disease, diabetes still remains amajor cause of morbidity and mortality in the modern world. AncientIndian medicine mentions various plants and mineral preparations inthe treatment of diabetes mellitus. There are different combinations ofthese plants and minerals which can be given orally and for prolongedperiods without any side-effects.

The goal for treatment of diabetes is to prevent its acutemanifestations and long-term micro vascular and macro vascular com-plications. NIDDM is one of the most common disorders in developedand developing countries 12. Reaven13 has reported that abnormalitiesof beta cell function and secretion exist in patients with NIDDM.

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Effects of combination of Shilajit extract and Ashwagandha(Withania somnifera) on fasting blood sugar and lipid profile

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Journal of Pharmacy Research Vol.2.Issue 5.May 2009

Avnish K. Upadhyay et al. / Journal of Pharmacy Research 2009, 2(5),897-899

O’Rahilly et al14 observed that the inherited component of familialType II diabetes may be the impaired insulin secreting response of thebeta cells. While fasting serum insulin may be in the normal range,glucose-induced insulin release is reduced, leaving below-normal in-sulin levels in the postprandial state. Oral hypoglycaemic drugs playan important role in the treatment of Type II diabetes mellitus but none

Parameters Initial after one month ‘t’ Value

FBS 148.9 ± 9.12 129.8 ± 8.36 3.11Cholesterol 165.3 ± 24.48 126.8 ± 12.23 3.08LDL 89.12 ± 15.4 72 ± 13.8 2.21Triglyceride 229.4 ± 12.44 205.28 ± 14.51 2.26VLDL 20.80 ± 6.12 14.04 ± 5.48 2.51TC/ HDL Ratio 2.88 ± 0.413 2.53 ± 0.401 1.85

Values expressed as mean ± SDFBS: Fasting Blood SugarLDL: Low Density LipidsVLDL: Very Low-Density LipoproteinTC: Total CholesterolHDL: High Density Lipoprotein

Table 1: FBS and Lipid profile in Subjects before and after onemonth intervention.

Figure-1: Average change in Fasting Blood Sugar (FBS)

Figure-2: Average change in Lipid Profile

have been found effective in maintaining euglycaemia15. In about one-quarter of patients with an initially good response, the drugs later losetheir effectiveness.Ashwagandha root, also known as winter cherryor Indian ginseng, is an important herb from the Ayurvedic or Indiansystem of medicine. Ashwagandha has been traditionally used for thetreatment of debility, emaciation, impotence, and premature aging16.Avery small study of 6 individuals with mild type 2 diabetes and 6 otherindividuals with mildly elevated cholesterol were treated withashwagandha for 30 days. A decrease in blood glucose was noted aswas a decrease in cholesterol and triglycerides17. Ashwagandha rootpowder decreased total lipids, cholesterol and triglycerides in hyper-cholesteremic animals. On the other hand, significantly increasedplasma HDL-cholesterol levels, HMG-CoA reductase activity and bileacid content of liver. A similar trend also reported in bile acid, choles-terol and neutral sterol excretion in the hypercholesteremic animalswith WS administration. Further, a significant decrease in lipid-peroxidation occurred in WS administered hypercholesteremic ani-mals when compared to their normal counterparts. However, WS rootpowder was also effective in normal subjects for decreasing lipid pro-files18. In another study it is established that Ashwagandha herb(Withania somnifera) compares favorably with metformin for lower-ing blood sugar, and seems to improve HDL cholesterol18.Shilajit findsextensive use in Ayurveda, for diverse clinical conditions. For centu-ries people living in the isolated villages in Himalaya and adjoiningregions have used shilajit alone or in combination with other plantremedies to prevent and combat problems with diabetes19. Medicalresearchers have taken a more serious interest in determining if theclaims regarding the antidiabetic effects of shilajit have scientific merit.Studies done by Gupta20 and Bhattacharya21 have also reported theantidiabetic actions of shilajit.Combination of shilajit (100 mg/kg) withglibenclamide (5 mg/kg/day) or metformin (0.5 gm/kg/day) significantlyenhanced the glucose-lowering ability and improvement in lipid pro-file than any of these drugs given alone. Shilajit is effective in control-ling blood glucose levels and improves the lipid profile22.Various herbsand minerals described in ayurvedic texts are very much effective inreducing blood sugar and lipid profile. In the present study we se-lected the fine extracts of Ashwagandha (Withania somnifera) andShilajit extract to evaluate the efficacy in NIDDM patients.

MATERIAL AND METHOD:

Subjects:

Thirty two (32) subjects with early diagnosed type-II diabe-tes (NIDDM) were enrolled in the trial. In these subjects 21 were Maleand 11 were Female participants and the mean age was 36±5.27. In-formed consent was obtained from all patients included in the trial. Allsubjects were on restricted diet and advised to follow diet chart givento him. A careful history was taken and a detailed examination carriedout. 5ml blood in to heparinized tubes to screen for Fasting bloodsugar and lipid profile. All the patients were examined for signs andsymptoms and their severity was recorded.

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Journal of Pharmacy Research Vol.2.Issue 5.May 2009

Avnish K. Upadhyay et al. / Journal of Pharmacy Research 2009, 2(5),897-899

ACKNOWLEDGEMENTS:

The authors are highly thankful to H.H. Acharya Balkrishna ji, Chair-man, R & D activities for guidance and providing facilities for workand Patanjali Ayurved Limited for providing investigational drug.

REFERENCES:

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2. Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence ofdiabetes: estimates for the year 2000 and projections for 2030. Dia-betes Care. 2004; 27:1047-1053.

3. Cockram C, Chan J. The epidemiology of diabetes in the WesternPacific Region (excluding Japan). In: Turle J, Kaneko T, Osato S (eds).Diabetes in the New Millennium. Sydney, Pot Still Press, 1999, p. 11–22.

4. Pradeepa R, Mohan V. The changing scenario of the diabetes epi-demic: implications for India. Indian Journal of Medical Research.2002; 116:121-32.

5. Ahuja MMS. Epidemiology studies on diabetes mellitus in India. In.Ahuja MMS (ed). Epidemiology of diabetes in developing countries,Interprint, New Delhi. 1979; pp 29 – 38.

6. Ramachandran A, Snehalatha C, Kapur A, Vijay V, Mohan V, Das AKet al. For the Diabetes Epidemiology Study Group in India (DESI).High prevalence of diabetes and impaired glucose tolerance in India:National Urban Diabetes Survey. Diabetologia 2001; 44:1094-1101.

7. Bjork S, Kapur A, King H, Nair J, Ramachandran A. Global policy:aspects of diabetes in India. Health Policy. 2003; 66:61-72.

8. Nadkarni AK. In: Indian Material Medica, Vol. 1 and 2. PopularPrakashan, Bombay, 1992.

9. Ajgaonkar SS. Ancient Indian Medicine and Diabetes Mellitus indeveloping countries. (Ed.) JS Bajaj, Interprint, New Delhi. 1984: pp3-10.

10. Upadhyay P, Pandey K. Ayurvedic approach to diabetes mellitus andits management by indigenous resources. In: Diabetes mellitus in de-veloping countries. 1984; 375-377.

11. Gupta SS. Prospects and perspectives of natural plant products inMedicine. Indian J of Pharmacology 1994; 26: 1-12.

12. Weir G.C. and Lealy J.L.: Pathogenesis of non-insulin-dependent (TypeII) Diabetes mellitus. In: Joslin’s diabetes mellitus (Eds); C.RonaldKalm and Gordon C. Weir, 13th Ed 1991, (14), 240.

13. Reaven G.M. Insulin secretion and Insulin action in non-insulin-de-pendent diabetes mellitus. Diabetes Care 7 (Suppl.1) 1984:17-24.

14. O’Rahilly S.P., Nugent Z and Rudenski A.S. Beta-cell dysfunction,rather than insulin insensitivity, is the primary defect in familial TypeII diabetes. Lancet 2 1986 360-63.

15. Lebovitz H.E. Oral antidiabetic agents. In: Joslin’s Diabetes mellitus(Eds): C. Ronald Kalm and Gordon C. Weir 1991: (29), 508.

16. Boone K. Withania – The Indian Ginseng and Anti-aging Adaptogen.Nutrition and Healing. Jun1998; 5(6):5-7.

17. Andallu B, Radhika B. Hypoglycemic, Diuretic andHypocholesterolemic Effect of Winter Cherry (Withania somnifera ,Dunal) Root. Indian J Exp Bi. Jun2000;38(6):607-9.

18. Hemalatha S, Wahi AK, Singh PN, Chansouria JP, “Hypoglycemicactivity of Withania coagulans Dunal in streptozotocin induced dia-betic rats. ”J Ethnopharmacol. 2004 Aug; 93(2-3):261-4.

19. Tiwari VP, Tiwari KC, Joshi PJ. An interpretation of Ayurvedikafindings on Shilajit. J Res Indigenous Med 1973; 8:57.  

20. Gupta SS. Effect of Shilajit, Ficus Bengalensis & ant. Pituitary extracton glucose tolerance in rats. Indian J Med Res 1966; 54:354-66.

21. Bhattacharya SK. Shilajit attenuates streptozotocin induced DM &decrease in pancreatic islet superoxide dismutase activity in rats.Phytother Res 1995; 9:41-4.

22. Trivedi NA, Mazumdar B, Bhatt JD, Hemavathi KG “Effect of shilajiton blood glucose and lipid profile in alloxan-induced diabetic rats” Ind.Journal of Pharma. 2004 (36-6), 373-376.

Investigational Drug:

Herbal capsules containing aqueous extract of Ashwagandha(Withania somnifera)-250mg and pure Shilajit extract-250mg were pre-pared as investigational drug. Two capsules of investigational drugnamed Ashwashila capsule were given in morning and evening to allsubjects.

Statistical Analysis:

Data is expressed as mean ± SD. Analysis of the results willbe made by using Student’s Paired “t” test between the initial valuesand at the end of one month.

RESULTS:

In this study, it was observed that out of 32 patients 18 sub-jects who were suffering from associated symptoms of diabetes likeexcessive thrust, fatigue etc had good improvement while conditionof 4 subjects had unchanged. Significant reduction is found in fastingblood sugar, low density lipids, very low-density lipoprotein , totalcholesterol/ high density lipoprotein ratio. The results of fasting bloodsugar and lipid profile is expressed in Table-1.

DISCUSSION:

Basic scientific studies of Ayurvedic medicine have not beenrigorously pursued. There are currently few RCTs and CCTs in theliterature, which hinders the assessment of efficacy. Future trials needto enroll an adequate number of subjects. Interventions should becompared to placebo preparations, and care should be taken to con-struct placebos that cannot be distinguished from the trial drug.Theclinical trials of Ayurvedic therapies for diabetes need to be betterreported. The method of patient selection and assignment to armsneeds to be better described, and the reporting of results should fol-low good statistical practice. In addition, the trials need to be of suffi-cient length to determine a relevant clinical effect.It would also beuseful to investigate the efficacy of single-herb therapies versus therelatively complex Ayurvedic formulas used. Present study demon-strates that the combination of Ashwagandha with Shilajit extract ex-hibits significant results on Fasting blood sugar, low density lipids,very low-density lipoprotein, total cholesterol/ high density lipopro-tein ratio.

CONCLUSION:

Based on the results of the study, it can be concluded thatcombination of Shilajit extract and Ashwagandha (Withania somnifera)can be a useful drug in the treatment of uncomplicated as well ascomplicated diabetes. Combination of Shilajit extract andAshwagandha (Withania somnifera) is very much effective in reduc-ing high lipids and cholesterol.

Source of support: Nil, Conflict of interest: None Declared

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