A study of pain reducing property of Terminalia chebula in healthy humans using pain model.
- Registration Number
- CTRI/2014/01/004346
- Lead Sponsor
- izams Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
• 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.
- Willing to give written informed consent to participate in the study.
• No history of Diabetes, Hypertension, recent use of analgesics
• Able to perform the test, as per the protocol procedure
• 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 NSAIDS 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 any of the study drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome: Increase in the pain threshold and pain tolerance time compared to that of baseline. <br/ ><br> <br/ ><br>Timepoint: A total of 4 Time points <br/ ><br>1. Pre-drug <br/ ><br>2. One hour post-drug <br/ ><br>3. Two hour post-drug <br/ ><br>4. Three hour post-drug
- Secondary Outcome Measures
Name Time Method Safety & Tolerability of Terminalia chebula in healthy human participants.Timepoint: A total of 4 Time points <br/ ><br>1. Pre-drug <br/ ><br>2. One hour post-drug <br/ ><br>3. Two hour post-drug <br/ ><br>4. Three hour post-drug