Safety of Aqueous Extract of Tinospora cordifolia (Tc) in Healthy Volunteers: A Double Blind

It is a common misconception that ayurvedic medicines (traditional Indian system of medicine) are always safe. In fact, they also pose serious health risks either in the form of adverse reactions or in the form of drug interactions. Over 80% of our population takes ayurvedic medicines. To evaluate the safety profile of Tinospora cordifolia in healthy volunteers using a battery of haematological, and biochemical tests and open questionnaire method. Thirty healthy volunteers (males - 22 and females - 8) aged 18 - 30 years (mean 22.5 ± 0.28) who volunteered to participate were studied in a randomized, double - blind, placebo controlled design. The volunteers were provided with 21 days of medication (coded box) containing Tinospora cordifolia 500 mg or matching placebo. One tablet of Tinospora cordifolia of 500mg strength or placebo was taken once daily orally in the morning along with breakfast for 21 days. The safety assessment was done with the help of haematological and biochemical investigations which were assessed before and after the medication. ‘Unpaired t test’ using SPSS computer software package. Analysis of the various lab values between the control and the test group before and after taking the drug/placebo by unpaired ‘t’ test shows no significant difference between the groups (P = > 0.05).Hence it can be concluded that Tinospora cordifolia is safe at a dose of 500mg per day for a period 21 days in healthy volunteers for the parameters studied.