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.

Background: Nowadays, safety of a drug is a major challenge than its efficacy. As the demand for Ayurvedic drugs is increasing day by day, the reporting of safety is essential.Objective: To review the clinical safety of Ayurvedic formulations, viz., Rajahpravartini vati Kanchanara Guggulu, Varunadi Kashaya, Ashokarishta, Ashvagandha Churna, and Pravala Pishti, which were trialed in 3 clinical trials on women's health to assess their efficacy and also clinical safety. Materials and methods:The analyzed data of 03 clinical studies on Kastartava (dysmenorrhea), menopausal syndrome, and polycystic ovary syndrome (PCOS) were collected from the Central Council for Research in Ayurvedic Sciences (CCRAS) database. These studies were conducted at 9, 3, and 2 centers on 359, 115, and 60 cases respectively, at the CCRAS institutes. The data have been critically evaluated to assay the clinical safety of the named six drugs trialed in these studies. All the studies were approved by the Institutional Ethics Committee conducted following the guidelines of good clinical practice. Written consent was obtained from the participants before their enrolment. Safety assessments were done by analyzing the laboratory parameters like liver function test and kidney function test before and after the trial periods. Paired sample t-test was used to compare the mean score. Any adverse drug reactions (ADRs) and side effects were also critically monitored. Results:In all the studies, it is observed that the safety laboratory parameters were within the normal range after drug administration in the participants, who were from different age groups, habitats, and prakriti. No cases of any ADR or drug intolerability were reported during the treatment period. Conclusion:From the results, it may be concluded that all the trial drugs are safe to use and can be used for a long period. Clinical significance:The results of the present study support the notion that if any Ayurvedic formulation has been manufactured as per good manufacturing practices (GMP) and administered at the recommended dose and duration, it is safe for human use.