None listed
Conditions
Interventions
None listed
Sponsors
Emami Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects who have never done power or resistance training or exercised fewer than four hours a week on a regular basis. 2. Subjects will have to perform four eccentric exercises (calf raises, hamstring curls, lying hip lifts, decline board knee bends) at the randomization visit to develop muscle soreness. 3. Willing to comply with all requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Subjects with no known musculoskeletal pathology 2. Subjects using systemic corticosteroids within 2 months of screening 3. Subjects with any other investigational drug within 1 month prior to randomization; 4. Subjects with uncontrolled diabetes mellitus and hypertension 5. Subjects with known tuberculosis, HIV, ischemic heart disease, cancer, kidney failure 6. Pregnant and lactating women 7. Subjects with significant abnormal laboratory parameters 8. Known hypersensitivity to any of the ingredients of study medication 9. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Number of subjects and days required for complete muscle recovery 2.Change in muscle pain or soreness on Visual Analogue Scale (VAS) Timepoint: Day 0, Day 3 and Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in perceived swelling or puffiness 2. Change on warmth over the muscle 3. Change in muscle tenderness to touch or palpation, muscle stiffness or reduced flexibility of the muscle 4. Requirement of rescue medications 5. Assessment of sticky appearance and staining after application of study product 6. Assessment of onset of action, duration of action, and relief period of muscle pain or soreness, counter irritancy and cooling effect following initial application of study product 7. Assessment of skin patch test 8. Global assessment for overall change by participants and by physician 9. Assessment of adverse events or adverse drug reactions including vitals Timepoint: Day 0, Day 3 and Day 7 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd
Outcome results
None listed