Comparative clinical evaluation of the antidyslipidaemic effects of Lashunadi compound and yogic exercises in patients of metabolic syndrome

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1 Indian Journal of Traditional Knowledge Vol. 10 (4), October 2011, pp Comparative clinical evaluation of the antidyslipidaemic effects of Lashunadi compound and yogic exercises in patients of metabolic syndrome Singh* Harbans, Sharma Anjali & Johar Smita Desh Bhagat Ayurvedic College & Hospital, Amloh, District Fatehgarh Sahib, PB *Herbal Ayurveda Research Centre, Nagaland University, Lumami , Nagaland Received ; revised In the present clinical trial, two groups of patients of metabolic syndrome have been studied to evaluate the therapeutic and antidyslipidaemic effect of Ayurvedic herbs and Yogic exercises. The group A of 25 patients was given Lashunadi compound containing equal quantity of Lashuna (Allium sativum Linn.), Gugullu (Commiphora wightii Hook.Ex. Stocks Engl) and Isabgol (Plantago ovate Forsk.) husk in the dosage of 6 gm, twice daily with lukewarm water. The group B of 25 patients was advised yoga therapy. The trial was conducted for two months and lipid and anthropometric profiles (body weight, body mass index & skin fold thickness) were periodically evaluated to assess the therapeutic and antidyslipidaemic effects of drugs under trial. At the end of the trial, group A exhibited its therapeutic and antidyslipidaemic efficiency over the group B. Keywords: Lashunadi compound, Yogic exercise, Metabolic syndrome, Antidyslipidaemic effect, Lashuna, Gugullu, Isabgol IPC Int. Cl. 8 : A01D 14/01, A01D 14/06, A01D 23/02, A01D 7/26, A01D 22/07 The epidemic of cardiovascular disease emerging in the developing countries during the past two decades has attracted the attention of cardiologists, diabetologists, endocrinologists and epidemiologists. It is a well established fact that all South Asians have the highest incidence of coronary artery disease. The incidence of coronary artery disease is increasingly affecting younger subsets of the population. The economic and healthcare burden on the society is the major factor responsible for this dismal scenario. The occurrence of metabolic and cardiovascular abnormalities that affects the body is known as metabolic syndrome. Metabolic syndrome is becoming increasingly common worldwide and is associated with significant cardiovascular and all cause mortality. The prevalence of metabolic syndrome is emerging as an important health problem in India. Metabolic syndrome is a multifaceted syndrome responsible for type 2 diabetes mellitus, obesity, hypertension, dyslipidaemia, hyperinsulinaemia and atherosclerotic cardiovascular diseases. Abdominal obesity and insulin resistance are *Corresponding author the main underlying abnormalities in the metabolic syndrome. Patients of metabolic syndrome present with almost similar co-morbidities to that of Upadravayukta Sthaulya (complicated obesity) mentioned in Ayurvedic treaties. Modern drug therapy of metabolic syndrome may be limited by adverse reactions, but requires alternative therapies. Herbal drugs are supposed to have benefits with fewer side effects, so there is a need to evaluate these herbal drugs scientifically. Therefore, it was decided to evaluate the therapeutic and antidyslipidaemic effects of Lashunadi compound and yogic exercises in patients of metabolic syndrome. Methodology The present clinical research was undertaken at Department of Kayachikitsa, Desh Bhagat Ayurvedic College & Hospital, Amloh, District Fatehgarh Sahib, Punjab. Patients were diagnosed as patients of metabolic syndrome on the basis of height and weight ratio, body mass index, clinical symptomatology, blood pressure, blood sugar and lipid profiles. Waist hip ratio was assessed to type out the kind of obesity and associated risks.

2 652 INDIAN J TRADITIONAL KNOWLEDGE, VOL 10, NO. 4, OCTOBER 2011 Diagnostic criteria: Presence of any 3 of following 5 criteria. 1 Elevated waist circumference 102 cm in men and 88 cm in women. 2 Elevated triglycerides 150 mg/dl. 3 Reduced HDL cholesterol < 40 mg/ dl in men and < 50 mg /dl in women. 4 Elevated blood pressure 130 mm of Hg systolic or 85 mm of Hg diastolic. 5 Elevated fasting glucose 100 mg /dl. Inclusion criteria: Patients in age group of yrs of either sex, individuals with fasting blood sugar in the range of mg/dl, & individuals with systolic blood pressure in the range of mm of Hg or diastolic blood pressure in the range of mm of Hg. Exclusion criteria: Patients of type 1 Diabetes mellitus, metabolic syndrome associated with endocrinal disorders like hypothyroidism, cushing syndrome, etc., any other criteria on which patients may be deemed unfit for trial and patients below 20yrs and above 70 yrs of age. Trial drugs and doses: On the basis of clinical experience, the drugs, Lashuna (Allium sativum Linn.), Guggulu (Commiphora wightii Hook.Ex. Stocks Engl) and Isabgol (Plantago ovata Forsk) husk were selected as antidyslipidaemic drugs. Fresh raw drugs were procured from market. After Botanical identification from the Department of Pharmacogonosy (Dravyguna). The drug preparation was done in hospital pharmacy under the supervision of highly specialized faculty of Ras-shastra Department. The standards of purity and quality, and packing were maintained. The present study was conducted on 63 patients and randomly divided into the two groups. Group A: Twenty nine patients were registered and 25 patients completed full course of treatment. These patients were given Lashunadi compound containing equal quantity of Lashuna (Allium sativum Linn.) powder, Guggulu (Commiphora wightii Hook.Ex. Stocks Engl) Vati and Isabgol (Plantago ovata Forsk) husk in the dose of 6gm twice a day with luke warm water. Group B: Thirty four patients were registered and 25patients completed full course of therapy. These patients were advised yoga therapy for 45 minutes twice daily for two months. The trial was conducted for two months. Results The effect of Lashunadi compound and Yogic exercises after two months of treatment, both subjective and objective evaluation criteria were applied. The reliable amongst them were anthropometric profile and lipid profile including serum cholesterol, serum triglycerides, and high density lipoproteins (HDL) low density lipoproteins, very low density lipoproteins (VLDL), non HDL cholesterol, LDL/HDL ratio and total cholesterol/hdl cholesterol. The trial patients were randomly divided into two groups, administration of trial drugs and results were monitored timely. The observation regarding subjective evaluation of the patients are given in Tables 1 & 2. The observation regarding anthropometric profile, lipid profile and blood sugar and blood pressure are given in Tables 3-8, respectively. Effect of Lashunadi compound on clinical trial: The effect of Lashunadi compound on symptomatology provided highly significant relief with 52.28% in weakness (daurbalya), 39.75% in perspiration (atisveda), 53% in dysponea (kshudraswasa), 43.47% in foetid odour (daurgandhya), 42.0% in polydipsia (pipasa atiyoga), % in polyphasia ( kshuda Atimatra), 36.14% in excessive sleep (ati-nindra), 46.24% in lassitude (javoprodh), 33% in joint pain (sandhi- shoola) and 51.80% in pendulous movements of buttocks, abdomen & breast (chal sphik udara stanam) (Table 1). Effect of Yogic exercise on clinical trial: The effect of yogic exercise on symptomatology provided significant relief with 33.12% in weakness (daurbalya), 31.92% in perspiration (atisveda), 23.0% in dysponea (kshudraswasa), % in foetid odour (daurgandhya), 15% in polydipsia (pipasa atiyoga), 19.41% in polyphasia (kshuda atimatra), % in excessive sleep (ati-nindra), 28.75% in lassitude (javoprodh), % in joints pain (sandhi-shoola) and % in pendulous movements of buttocks, abdomen & breast (chal sphik udara stanam) (Table 2).

3 SINGH et al.: CPMPARATIVE CLINICAL EVALUATION OF ANTIDYSLIPIDAEMIC EFFECTS & YOGIC EXERCISES 653 Table 1 Effect of Lashunadi compound on clinical features in patients of metabolic syndrome in group A Clinical features Mean Diff. % age relief S.D. ± S.E. ± t P Weakness (Daurbalyam) <0.001 Perspiration (Atisveda) <0.001 Dyspnoea on exertion (Kshudrashwasa) <0.001 Foetid odour (Daurgandhya) >0.05 Polydipsia (Pipasa Atiyoga) <0.05 Polyphasia (Kshuda Atimatra) <0.05 Excessive sleep (Atinidra) <0.001 Lassitude (Javoprodh) <0.001 Joint Pain (Sandhi Shoola) <0.05 Pendulous movements of Buttocks, Abdomen & Breast (Chal Sphika Udara Stanam) <0.001 Table 2 Effects of Yogic exercises on clinical features in patients of metabolic syndrome in group B Clinical features Mean Diff. % age relief S.D. ± S.E. ± t P Weakness (Daurbalyam) <0.01 Perspiration (Atisveda ) <0.05 Dyspnoea on Exertion <0.05 (Kshudrashwasa) Foetid odour (Daurgandhya) >0.05 Polydipsia (Pipasa Atiyoga) >0.05 Polyphasia (Kshuda Atimatra) <0.05 Excessive sleep (Atinidra) <0.05 Lassitude (Javoprodh) <0.05 Joint Pain (Sandhi Shoola) >0.05 Pendulous movements of Buttocks, Abdomen & Breast (Chal Sphiga Udara Stanam) <0.05 Table 3 Effect of Lashunadi compound on anthropometric profile in patients of metabolic syndrome in group A Anthropometric parameters Mean Diff. % age reduction S.D. ± S.E. ± t P Weight in Kg <0.05 Body Mass Index <0.05 Waist Circum <0.01 Hip Circum <0.01 Waist/Hip Ratio <0.05 Chest Circum <0.05 S.F.T. Biceps <0.05 S.F.T.Triceps <0.01 S.F.T.Suprailiac <0.001 S.F.T.Subscapularis <0.01

4 654 INDIAN J TRADITIONAL KNOWLEDGE, VOL 10, NO. 4, OCTOBER 2011 Table 4 Effect of Yogic exercises on anthropometric profile in patients of metabolic Syndrome in group B Anthropometric parameters Mean Diff. % age reduction S.D. ± S.E. ± t P Weight in Kg <0.001 Body Mass Index <0.001 Waist Circum <0.001 Hip Circum <0.001 Waist/Hip Ratio <.05 Chest Circum <0.001 S.F.T. Biceps <0.001 S.F.T.Triceps <0.001 S.F.T.Suprailiac <0.001 S.F.T.Subscapularis <0.001 Table 5 Effect of Lashunadi compound on lipid profile in patients of metabolic syndrome in group A Biochemical investigations Mean Diff. % age change S.D. ± S.E. ± t P S. Cholesterol <0.001 S. Triglyceride <0.001 H.D.L <0.001 L.D.L <0.001 V.L.D.L <0.05 Non HDL Cholesterol <0.001 Cholesterol/HDL Ratio <0.001 LDL/HDL Ratio <0.001 Table 6 Effects of Yogic exercises on lipid profile in patients of metabolic syndrome in group B Biochemical investigations Mean Diff. % age change S.D. ± S.E. ± t P S. Cholesterol <0.05 S. Triglyceride <0.05 H.D.L >0.05 L.D.L <0.05 V.L.D.L <0.05 Non HDL Cholesterol <0.05 Cholesterol/HDL Ratio <0.05 LDL/HDL Ratio >0.05 Table 7 Effect of Lashunadi compound on blood sugar and blood pressure in patients of metabolic syndrome in group A Parameters Mean Diff. % age reduction S.D. ± S.E. ± t P S.B.P <0.05 D.B.P <0.05 F.B.S <0..01 P.P.B.S < SBP = Systolic blood pressure DBP = Diastolic blood pressure FBS = Fasting blood sugar PPBS = Post prandial sugar

5 SINGH et al.: CPMPARATIVE CLINICAL EVALUATION OF ANTIDYSLIPIDAEMIC EFFECTS & YOGIC EXERCISES 655 Table 8 Effect of Yogic exercises on blood sugar and blood pressure in metabolic syndrome patients of in group B Parameters Mean Diff. % age reduction S.D. ± S.E. ± t P S.B.P <0.05 D.B.P <0.05 F.B.S <0.001 P.P.B.S <0.001 Effect on Body weight: Weight reduction in group - A was 6.00% and in group-b was 3.1%. Average weight reduction was 5.13 Kg in group A and 2.73 Kg in group-b (Tables 3-4). Body mass index: Reduction of BMI in group- A was 5.9% with an average reduction to Kg/m 2 from Kg/m 2. In group-b this reduction was 3.2% with an average reduction to Kg/m 2 from 32.68Kg/m 2 (Tables 3-4). Effect on skin fold thickness In group-a reduction in various skin, fold thickness, i.e. in biceps 14.31%, in triceps 14%, in suprailiac 11%and in subscapularis 17.62%were observed. In group-b reduction in various skin fold thickness i.e. in biceps13.80%, in triceps 10.17%, in suprailiac 11.60% and in subscapularis 13.30% were observed (Tables 3-4). Effect on waist, hip and chest circumferences Considering the effect of Lashunadi compound on Medovriddhi it provided highly significant relief with 4.86%in waist circumference, 3.40% in hip circumference, and 1.95% in chest circumference. Considering the effect of Yogic exercises on Medovriddhi it provided highly significant relief with 3.53% in waist circumference, 1.92% in hip circumference, 1.72% in chest circumference (Tables 3-4). Effect of therapies on lipid profile The effect of Lashunadi compound on lipid profile provided highly significant reductions with 12.0% in S.Cholesterol, 11.30% in S.Triglycerides, 17.9% increase in H.D.L., 20.4% in L.D.L., 15.6% in V.L.D.L., 18.2% in non-hdl Cholesterol, 26.2% in total cholesterol/hdl ratio and 33.4% in LDL/HDL ratio (Table 5). The effect of Yogic exercises on lipid profile provided significant reduction with 6.5% in S. Cholesterol, 7% in S. Triglycerides, 5% increase in HDL, 9. 2% in LDL, 7.1% in VLDL, 9.5% in non-hdl cholesterol, 10.6% in total cholesterol/hdl ratio and 13.1% in LDL/HDL ratio (Table 6). Effect of therapies on blood sugar and blood pressure Statistically significant reduction was observed in fasting blood sugar (FBS), post prandial blood sugar (PPBS), systolic and diastolic blood pressure in both groups (Tables 7-8). Discussion Physical inactivity, age, atherogenic diet and hormonal imbalance are important in the pathogenesis of obesity (Sthaulya) or insulin resistance/metabolic syndrome1-3. Genetic factors and South Asian ethnicity also contribute significantly1-4. Hyperinsulinaemia is believed to be atherogenic5. Hyperinsulinaemia may activate the sympathetic nervous system and also cause salt and water retention6. Adipose tissue in obese people is insulin resistant and therefore, development of obesity in individuals genetically predisposed to insulin resistance may initiate the complex series of changes ultimately resulting in the metabolic syndrome.sthaulya has been described among the eight worst despicable diseases (Ch. Su. 21)7. The drugs like Lashuna, Guggulu & Isabgol have been suggestive to be useful in Shathulya/ metabolic syndrome8-9. The present trial is exploration of ancient Ayurvedic literature to screen and dose standardization of the powders of herbal drugs in the patients of metabolic syndrome. The antidyslipidaemic activities of Lashunadi compound containing Lashuna, Guggulu & Isabgol could be attributed to several mechanisms including inhibition of cholesterol biosynthesis and enhancement in cholesterol degradation and/or excretion. Guggulu competitively inhibits conversion of 3-hydroxy-3-methyl glutaryl coenzyme A (HMG C O A) to mevalonate by the enzyme HMG C O A reductase, thus blocks the cholesterol synthesis. Guggulu compounds are antagonist s ligands for bile acid receptors called Farnesoid X receptor (FXR), which is an important regulator of cholesterol homeostasis. It is likely that this effect accounts for the hypolipidaemic activity. The hypolipidaemic effect of Lashuna has been attributed to Allicin which binds to sulphhydral compound that are involved in

6 656 INDIAN J TRADITIONAL KNOWLEDGE, VOL 10, NO. 4, OCTOBER 2011 the synthesis of cholesterol. Isabgol possess large amount of albuminous matter and mucilage. This herb has antidiabetic properties and is beneficial in diabetic treatment. It prevents excess absorption of sugar from the intestine and thereby helps control blood sugar in diabetics. In Ayurvedic therapeutics, it is believed that these drugs can act at the level of dhatwagni and by its promotion will help to decrease the quantity of apakava meda dhatu of which baddha meda (adipose tissue) is a part and in this process also decrease the production of abaddha meda (circulating lipids) 10. Weight loss leads to significant improvement in insulin resistance. This will in turn normalize the clinical manifestations, anthropometric profile, blood pressure, blood sugar and lipid profile towards normal range. The baddha meda (adipose tissue) of body are mobilized/burnt out (vilayana of meda), by these drugs to convert them into abaddha meda which on further degradation in liver are converted into various types of fatty acids and glycerol, etc. Since excess fat of body (baddha meda) is mobilized/burnt out (vilayana of meda), it is the main outcome of the use of lekhaniya drugs in the body. Yogic exercises are the most important life style modification which has a positive impact on insulin sensitivity and cardiovascular fitness 11. It benefits by improving insulin resistance, lowering levels of triglycerides and free fatty acids and increasing HDL cholesterol 11. It may also improve endothelial function and cause increased release of nitric oxide. Exercise has the added benefit of facilitating weight loss. Weight reduction and exercise not only prevent the syndrome but also play an important in reversing many of the metabolic abnormalities. The patients of both groups showed statistically significant improvement in the clinical manifestations along with reduction in markers of metabolic syndrome, i.e. anthropometric profile (body weight, body mass index and skin fold thickness), blood pressure, blood sugar and lipid profile towards normal range. But patients of trial group A exhibited its therapeutic and antidyslipidaemic efficiency over the group B. There were no clinically significant adverse events, either reported or observed, during the entire study period. Conclusion Lashunadi compound (Kalpita) containing Lashuna, Guggulu and Isabgol in dosage of 6 gm, twice daily, is a favoured drug for metabolic syndrome because of its oral effectiveness, good safety profile, easily availability in India and most importantly at an affordable price. It has established effective antidyslipidaemic, antihypertensive and antihyperglycemic effects as the components of the compound drug have produced statistically significant improvement in the clinical manifestations, anthropometric profile and also reduction in lipid profile, blood sugar and blood pressure towards normal range. Lashunadi compound (6 gm twice daily) is more effective than yogic exercises as the results obtained in the patients treated with former are better than those treated with later. Thus it can be concluded that Lashunadi compound normalizes the circulating lipids and also helps to decrease high morbidity and mortality due to the complications of metabolic syndrome. References 1 Reaven G M, Role of insulin resistance in human disease, Diabetes, 37 (1988) Grundy S M, Cleeman J I & Daniels S R, Diagnosis and management of the metabolic syndrome, An American Heart Association / National Heart, Lung and Blood Institute Scientific statement, Circulation, 112 (2005) Kahn R, Ferrannini E & Buse J, The metabolic syndrome. Time for a critical appraisal, Diabetes Care, 28 (2005) Yusuf S & Ounpuu S, Tackling the growing epidemic of cardiovascular disease in South Asia, J Am Coll Cardiol, 38 (2001) Reaven G, Metabolic syndrome. Pathophysiology and implications for management of cardiovascular disease, Circulation, 106 (2002) Reaven G M, Lithell H & Landsberg L, Hypertension and associated metabolic abnormalities- The role of insulin resistance and the sympathoadrenal system, N Engl J Med, 334 (1996) Charak Samhita, Commentary by Shastri Kashi Nath & Chaturvedi GN, (Chowkhamba Publication, Varanasi), Kirtikar KR & Basu BD, Indian Medicinal Plants, Vol. I-IV, 2 nd edn, (Lalit Mohan Basu, Allahbad), Mishra Bhava: Bhavaprakasha Nighantu, Commentry by Dr KC Chunekar, (Chowkhanbha Bharti Academy, Varanasi), Singh Harbans, A clinical study of hypolipidaemic effects of certain Ayurvedic herbal drugs in patients of Medoroga (Obesity) with special reference to dyslipidaemias,thesis submitted for PhD (Ayurveda) in Kayachikitsa, Rajasthan Ayurveda University, Jodhpur), Bloomarden Z T, Second world congress on the insulin resistancesyndrome: Hypertension, cardiovascular disease & treatment approach, Diabetes Care; 28(2005)