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RESEARCH ARTICLE
Year : 2018  |  Volume : 3  |  Issue : 4  |  Page : 123-129

Efficacy and safety of Vidangadi Yoga (ayurvedic polyherbal medicine) in type 2 diabetes mellitus: A randomized controlled clinical study


1 Parul Institute of Ayurved, Parul University, AP Limda, Tal Waghodia, Vadodara, Gujarat, India
2 PDEA's College of Ayurved and Research Centre, Sector 27, Akurdi, Pradhikaran, Pune, India

Correspondence Address:
Shailesh Vinayak Deshpande
Parul Institute of Ayurved, Parul University, AP Limda, Tal Waghodia, Vadodara, Gujarat
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2542-3975.248011

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Background and objectives: Incidence of diabetes mellitus is increasing due to genetic predisposition, high body fat, and insulin resistance. Though multiple oral hypoglycaemic agents and insulin are available, these are associated with side effects, primary and secondary failure. Hence, evaluation of antidiabetic potential of medicines described in traditional health sciences such as Ayurveda (Indian system of medicine) is also important. This study aimed to assess the efficacy and safety of Vidangadi Yoga (ayurvedic polyherbal medicine) and metformin in the management of type 2 diabetes mellitus (T2DM) based on biochemical parameters and adverse events. Methods: In this prospective, randomized, open-label, active-controlled, two-arm study, 61 patients with T2DM were included and randomly divided two groups. Patients in the Vidangadi Yoga group received Vidangadi Yoga tablet 500 mg thrice daily before food with water, while patients in the metformin group received metformin 500 mg after food twice daily for 90 days. Subjects were asked to undergo follow-up at the interval of 15 days until the completion of 90 days. Assessment was done on changes observed in fasting and postprandial blood glucose, glycosylated haemoglobin, lipid profile, haemogram, hepatic, renal profile, and clinical symptoms. Results: After 90 days of medication, fasting and postprandial blood glucose levels in both groups were significantly decreased when compared with baseline (P < 0.001). There were no significant differences in fasting and postprandial blood glucose levels between both groups. After 90 days of medication, haemogram, and hepatic and renal profiles (safety parameters) in the two groups were not significantly different from baseline. No adverse events were related with the use of the studied medicine. Conclusion: Vidangadi Yoga exhibits equivalent efficacy to metformin and is safe in lowering fasting and postprandial blood glucose levels. Ethics and trial registration: This study was approved by the institutional ethics committee of PDEA’s College of Ayurved and Research Centre, Pune, Maharashtra, India (approval number 6833) on March 22, 2014 and was registered with Clinical Trials Registry- India (CTRI) (No. CTRI/2015/04/005719) on April 25, 2015.


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