Evaluation of the Analgesic Activity of Standardized Aqueous Extract of Terminalia chebula in Healthy Human Participants Using Hot Air Pain Model

摘要

Background: Pain affects millions of people worldwide, opioidanalgesics have been used for chronic painful conditions. Dueto their adverse effects, safer alternatives would be beneficial.Terminalia chebula, with proven analgesic action has beenevaluated in the hot air pain model for its analgesic activity.Aim: To evaluate analgesic activity and safety of single oraldose of Terminalia chebula using hot air pain model in healthyhuman participants.Setting and Design: Randomized, Double blind, Placebocontrolled, Cross over study.Materials and Methods: After taking written informed consentto IEC approved protocol, 12 healthy human participants wererandomized to receive either single oral dose of two capsules ofTerminalia chebula 500 mg each or identical placebo capsulesin a double blinded manner. Thermal pain was assessed usinghot air analgesiometer, to deliver thermal pain stimulus. MeanPain Threshold time and Mean Pain Tolerance time measuredin seconds at baseline and 180 minutes post drug. A washoutperiod of two weeks was given for cross-over between the twotreatments.Results: Terminalia chebula significantly increased mean painthreshold and tolerance time compared to baseline and placebo.Mean pain threshold time increased from 34.06±2.63 secondsto 41.00±2.99 seconds (p<0.001) and mean pain tolerance timeincreased from 49.67± 3.72 seconds to 57.30±3.07 seconds(p<0.001). The increase in mean percentage change for painthreshold time is 20.42% (p<0.001) and for pain tolerance timeis 17.50% (p<0.001).Conclusion: In the present study, Terminalia chebula significantlyincreased Pain Threshold time and Pain Tolerance timecompared to Placebo. Study medications were well tolerated.