Evaluation of the analgesic activity of standardized aqueous extract of Withania somnifera in healthy human volunteers using Hot Air Pain Model.

Abstract

Pain is the most prevalent health care problem. Most analgesics available today have good analgesic activity but are associated with lot of side effects. So analgesics with minimal side effects are required which can be evaluated by hot air pain model in healthy volunteers. Withani somnifera with various properties due to its active constituents-withanolides is widely used in Ayurvedic medicine. This study was done to evaluate the analgesic effect and tolerability of single oral dose (1000mg) of standardized aqueous extract of Withania somnifera using Hot Air Pain model in healthy human volunteers as per ICH GCP Guidelines after taking written informed consent to protocol approved by IEC. Subjects were randomised to receive either single oral dose of 1000mg standardized aqueous extract of Withania somnifera or identical placebo in a double blind manner. Mean Pain Threshold Time at baseline and 3hrs after drug administration were noted. Washout period of 10-14 days was given for cross-over between the two treatments. Safety assessments were conducted before and at end of study Total twelve subjects were enrolled. Mean Pain Threshold Time with Withania somnifera increased from 43.99±6.79 to 49.89±7.07 sec (p<0.05). No significant change was observed with placebo. Both drugs were well tolerated.