Evaluation of Cardiovascular and Pharmacodynamic Effects of Single and Multiple Doses of Aqueous and Hydro- Alcoholic Extracts of Tinospora cordifolia in Healthy Human Male Subjects

Objective: To evaluate the cardiovascular and pharmacodynamic effects of single and multiple doses of Tinospora cordifolia (Aqueous and Hydro-alcoholic extracts) in healthy human male subjects. Method:Randomized, double blind, placebo-controlled dose ranging study. After approval from the institutional ethics committee, written informed consent was taken from subjects. Eligible subjects were allocated to the single and multiple dose groups, with six subjects in each group. The active treatment (Aqueous and Hydro-alcoholic extracts of Tinospora cordifolia) and placebo capsules were administered in 2:1 ratio in all the study groups. Vital parameters and pharmacodynamic assessment of cardiac profiling were performed using cold pressor test (CPT), tilt table and platelet aggregation tests. The data was presented as mean ± SD. No statistical tests were applied as the sample size was less (n=6 in each group). Result: During CPT, Tinospora cordifolia attenuated the rise in SBP, DBP and pulse rate in all the treatment groups compared to baseline. The CPT induced arterial stiffness was counteracted by treatment with single dose and multiple doses of aqueous and hydro-alcoholic extracts Tinospora cordifolia. Treatment with single doses of aqueous and hydro-alcoholic extracts Tinospora cordifolia produced a mild increase in cardiac output during 450 & 600 phases of the tilt. Treatment with multiple doses of aqueous and hydro-alcoholic extracts Tinospora cordifolia increased cardiac output at 600 tilt (Day 1) and at 450 & 600 phases of the tilt (Day 11). Conclusion: Treatment with single and multiple doses of Tinospora cordifolia produced remarkable changes in the cardiovascular profile. Further studies in larger number of subjects and in patients with cardiovascular diseases are needed to confirm these effects