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Journal of Research in Ayurvedic Sciences 2017 July- September ; 1 (3) :142-149
Clinical Safety of Selected Ayurvedic Formulations in Obesity and Dyslipidemia
Bhagwan S Sharma (1), Bhagwan S Sharma (1), Sarada Ota (1), Sarada Ota (1), Shruti Khanduri (1), Shruti Khanduri (1), Babita Yadav (2), Babita Yadav (2), Pradeep Dua (1), Pradeep Dua (1), Kishore Kumar (3), Kishore Kumar (3), Rohit K Ravte (4), Rohit K Ravte (4), Puthenveettil KS Nair (5), Puthenveettil KS Nair (5), Meda M Rao (6), Meda M Rao (6), Rajesh Sannd (7), Rajesh Sannd (7), P Radhakrishnan (8), P Radhakrishnan (8), Varanasi Subhose (9), Varanasi Subhose (9), Sanjay K Giri (10), Sanjay K Giri (10), Rajesh Kumari (11), Rajesh Kumari (11), Rakesh K Rana (12), Rakesh K Rana (12)
1. Research Officer (Ayurveda), Central Council for Research in Ayurvedic Sciences, New Delhi, India 2. Research Officer (Ayurveda), Central Council for Research in Ayurvedic Sciences, New Delhi, India 3. Research Officer (Ayurveda),Regional Ayurveda Research Institute for Metabolic Disorders Bengaluru, Karnataka, India 4. Research Officer (Ayurveda), Central Ayurveda Research Institute for Drug Development Kolkata, West Bengal, India 5. Former Assistant Director (Ayurveda), Central Ayurveda Research Institute for Neuromuscular & Musculo-Skeletal Disorders, Cheruthuruthy, Kerala, India 6. Director (Ayurveda), Central Ayurveda Research Institute for Hepatobiliary Disorders Bhubaneswar, Odisha, India 7. Assistant Director (Ayurveda),Central Council for Research in Ayurvedic Sciences, Patiala Punjab, India 8. Assistant Director (Ayurveda),Central Ayurveda Research Institute for Neuromuscular & Musculo-Skeletal Disorders, Cheruthuruthy, Kerala, India 9. Assistant Director (Ayurveda), Regional Ayurveda Research Institute for Drug Development Gwalior, Madhya Pradesh, India 10. Research Officer (Ayurveda), Regional Ayurveda Research Institute for Metabolic Disorders Bengaluru, Karnataka, India 11. Research Officer (Ayurveda),Central Council for Research in Ayurvedic Sciences, New Delhi, India 12. Statistical Officer (Ayurveda), Central Council for Research in Ayurvedic Sciences, New Delhi, India
Abstract
Introduction: Obesity is a condition of abnormal or excessive fatness, and dyslipidemia is a condition with abnormal raised levels of any one or all lipids in the blood. Ayurveda compares signs and symptoms of obesity and dyslipidemia with the disease Sthaulya/Medoroga. Vyoshadi Guggulu and Haritaki Churna are the most commonly used medicines in the management of Sthaulya. However, the safety of these drugs was not evaluated until now through clinical trials. Objective: The objective of this study was to assess clinical safety of Vyoshadi Guggulu and Haritaki Churna in the management of obesity (Sthaulya) and dyslipidemia. Materials and methods: A prospective, open-label multicentric study was carried out at peripheral institutes of the Central Council for Research in Ayurvedic Sciences (CCRAS). Total 306 patients satisfying selection criteria were randomly selected from the outpatient department of respective centers and were administered Vyoshadi Guggulu (3 tablets of 500 mg) and Haritaki Churana (3 gm twice daily) in case of obesity, and Vyoshadi Guggulu (2 tablets of 500 mg thrice in a day) and Haritaki Churana (3 gm twice daily in cases of dyslipidemia) with lukewarm water for 12 weeks. So, the daily intake of the medicine was similar in all these cases. Hematological parameters, viz., lipid profile, and safety parameters were assessed at baseline and at the end of 12 weeks. Paired sample t-test was applied to compare the changes. Results: At the end of 12 weeks, compared with baseline, no statistically significant difference was observed in liver function tests (LFTs) and kidney function tests (KFTs) in the subjects. Conclusion: The findings clearly indicate that Vyoshadi Guggulu and Haritaki Churna are clinically safe and tolerable in subjects with obesity and dyslipidemia belonging to different age groups, gender, geographical area, and different Prakrti. Keywords: Dyslipidemia, Haritaki Churna, Obesity, Sthaulya, Vyoshadi Guggulu.
DHARA ID: D059569
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