None listed
Conditions
Interventions
Intervention1: Terminalia chebula capsules: Single dose of 2 capsules of Terminalia chebula 500mg each given orally 3 hours before the test
Control Intervention1: Placebo: Single dose of 2 Identical P
Sponsors
Nizams Institute of Medical Sciences
Eligibility
Inclusion criteria
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. - 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
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: Increase in the pain threshold and pain tolerance time compared to that of baseline. Timepoint: A total of 4 Time points 1. Pre-drug 2. One hour post-drug 3. Two hour post-drug 4. Three hour post-drug | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety & Tolerability of Terminalia chebula in healthy human participants.Timepoint: A total of 4 Time points 1. Pre-drug 2. One hour post-drug 3. Two hour post-drug 4. Three hour post-drug | — |
Countries
India
Contacts
Public ContactDr KISHAN P V
Nizams Institute of Medical Sciences
Outcome results
None listed