A study on the pain reducing effect of terminalia chebula.

Not Applicable

Completed

• Registration Number: CTRI/2014/10/005106
• Lead Sponsor: IZAMS INSTITUTE OF MEDICAL SCIENCES

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

•Healthy male participants aged 18 â?? 45yr, with a body mass index (BMI) 19.5 â?? 25.9 kg/m2 will be included in the study.

•The participants having pain tolerance time between 30 sec and 180 sec with short level and high heat intensity will be included into the study.

•Patients who will provide written informed consent to participate in the study.

•Able to perform the test, as per protocol procedure

•No history of diabetes ,hypertension, GIT disorders

Exclusion Criteria

•Uncooperative subjects.

•Prior wounds or fractures on the tested extremity

•Any significant abnormality identified on physical examination or laboratory tests.

•Smokers, Alcoholics, drug abusers (amphetamines, cocaine, sympathomimetics, systemic glucocorticoids, anabolic steroids, will be not included in the study.

•Participants using other anti oxidants and over the counter medications.

•Participants using other non-steroidal anti-inflammatory drugs in the past 2 weeks.

•Use of other investigational drugs at the time of enrollment, or within 3 months prior to this study.

•History of hypersensitivity to the study drug

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increase in the pain threshold and tolerance time compared to baseline.Timepoint: PAIN THRESHOLD and PAIN TOLERANCE AT 4 Time points <br/ ><br>1. Pre-drug(baseline) <br/ ><br>2. 45 minutes post-drug <br/ ><br>3. 90 minutes post-drug <br/ ><br>4. 180 minutes post-drug

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of Terminalia chebula in healthy human participantsTimepoint: AT 3 Time points <br/ ><br> <br/ ><br>1. 45 minutes post-drug <br/ ><br>2. 90 minutes post-drug <br/ ><br>3. 180 minutes post-drug