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Journal of Research in Ayurvedic Sciences 2018 July- September ; 2 (3) :180-187
Clinical Safety of Selected Ayurvedic Formulations in Diabetes Mellitus–A Pharmaco-epidemiological Perspective

Abstract
Background: Ayurveda is an ancient system of medicine popularly practiced in India. Many types of researches on various disease conditions have been conducted, but the reporting of clinical safety is negligible. Nowadays, the safety of the drugs is as important as efficacy. Objective: Reporting of clinical safety of certain Ayurvedic formulations which were trialed in diabetes mellitus (DM) (Madhumeha) through four multicentre open-label clinical studies at Research centers of Central Council for Research in Ayurvedic Sciences situated in different geographical regions. Materials and Methods: The analyzed data of four different clinical studies were critically evaluated to assay the safety profile of Ayurvedic herbal/herbomineral formulations namely, Saptavimshatika Guggulu and Haridra Churna, Nisha Amalaki and Chandraprabha Vati, Nisha katakadi kashaya and Yashada Bhasma, Gokshuradi Guggulu and Guduchi Churna. In all the studies, the drugs were administered for three months. Safety assessments have been done through analyzing laboratory parameters like Liver function test and renal function test before and after the trial period. Paired sample t-test has been used to compare the mean changes of these parameters from baseline to the end of the trial period. Any adverse drug reaction (ADR)/ adverse events (AE), if any, were noted. Patient compliance was maintained during the study. Result: The results revealed that all the safety laboratory parameters were within the specified limits and no ADR was reported during the entire study period. Conclusion: All the trialed drugs used on the subjects of Madhumeha are clinically safe and tolerable, in spite of the subjects belonging to different geographical locations, Prakriti, gender and age groups. Significance: Above findings will assure the researchers as well as the public about the safety of these Ayurvedic formulations. Keywords: Ayurvedic herbal/herbo-mineral formulations, Clinical safety, Diabetes mellitus, Madhumeha, Pharmacoepidemiological study.

DHARA ID: D059603


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