None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in the pain threshold and tolerance time compared to baseline.Timepoint: PAIN THRESHOLD and PAIN TOLERANCE AT 4 Time points 1. Pre-drug(baseline) 2. 45 minutes post-drug 3. 90 minutes post-drug 4. 180 minutes post-drug | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of Terminalia chebula in healthy human participantsTimepoint: AT 3 Time points 1. 45 minutes post-drug 2. 90 minutes post-drug 3. 180 minutes post-drug | — |
Countries
India
Contacts
Nizams Institute of Medical Sciences