Health Condition 1: M959- Acquired deformity of musculoskeletal system, unspecified
Conditions
Interventions
None listed
Sponsors
Tirupati Pharma, India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex aged above 18 years. 2. Patients who are able to understand written and/or verbal instructions and are ready to comply with all study requirements with a willingness to participate and give written informed consent voluntarily. 3. Patients who had been diagnosed with acute and chronic localized musculoskeletal pain and joint pain (arthritis) .
Exclusion criteria
Exclusion criteria: 1. Women of child bearing potential who are either unwilling or unable to use an acceptable method of birth control to avoid pregnancy during the study period. 2. Subject with active skin lesions or other skin diseases. 3. Subject with history of uncontrolled diabetes 4. Subject with history of Periarthritis, rheumatoid arthritis 5. Known allergy to compounds of investigational product. 6. Participation in an investigational drug trial in the30 days prior to the screeningvisit. 7. Patients of vulnerable group (children, lactating mother, elderly >80 years,handicapped, seriously ill, mentally challenged). 8. History of drug or alcohol abuse during the last 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Time to onset of relief of pain 2. Time to onset of cooling/warmth/tingling/burning sensation 3. Time to achieve complete relief of pain 4. Reduction in pain score on numeric pain rating scale AT REST and during MOVEMENT 5. Changes in joint/Musculo skeletal pain intensity measured by Pain VAS Scale (0-100 mm) 6. Time interval between onset of pain relief and the need for second application of test / comparator product for pain relief 7. Subjects overall satisfaction for pain relief on a 7- point Likert Satisfaction scale 8.User perception was assessed with a 5- point Likert Satisfaction scale 9. Number of patients requiring rescue medication 10. Changes in C Reactive Protein and ESR 11. Changes in Quality of life Questionnaires (Short Form Health-12) and the WOMAC Pain score and McGill Pain Questionnaire for pain intensity.Timepoint: Day 1 [Time frame: 30 seconds, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes and hourly upto 8 hours post dose] , day 7 to day 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events and serious adverse events during the study period Brief clinical examination Timepoint: Day 1, day 7 to day 10 | — |
Countries
India
Contacts
Public ContactDr Gayathri Sivakumar
Thirumalai medical Centre, ki3
Outcome results
None listed