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

Rao, Yeshwanth Karkal and Bairy, Laxminarayana K (2007) Safety of Aqueous Extract of Tinospora cordifolia (Tc) in Healthy Volunteers: A Double Blind Randomised Placebo Controlled Study. Iranian Journal Of Pharmacology & Therapeutics, 6 (1). pp. 59-61.

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Abstract

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. The study was aimed to evalu-ate 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 cordifo-lia 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 by unpaired t test. ‘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.

Item Type: Article
Uncontrolled Keywords: Healthy Volunteers, Safety, Tinospora Cordifolia
Subjects: Medicine > KMC Manipal > Pharmacology
Depositing User: KMC Manipal
Date Deposited: 10 Jan 2012 05:21
Last Modified: 10 Jan 2012 05:21
URI: http://eprints.manipal.edu/id/eprint/2236

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