Health Condition 1: M15-M19- Osteoarthritis Health Condition 2: M255- Pain in joint
Conditions
Interventions
Intervention1: Trubliss pain relief gel (Cinnamomum Camphore 2 percentage,
Trachyspermum Ammi-0.2 percentage
Cannabis Sativa- 6 percentage
Gaultheria Fragrantissima- 17 percentage
Mentha Species- 11.
Sponsors
Trubliss International
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex aged above 18 years. 2. Patients who can 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 have been diagnosed with acute and chronic localized musculoskeletal pain and joint pain (arthritis) disorders.
Exclusion criteria
Exclusion criteria: 1. Women of childbearing 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. Known allergy to compounds of investigational product. 5. Participation in an investigational drug trial in the 30 days prior to the screening visit. 6. Patients of vulnerable group (children, lactating mother, elderly greater than 80 years, handicapped, seriously ill, mentally challenged). 7.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 [Time frame: 0-120 minutes post dose] 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 7. Time interval between onset of pain relief and the need for second application of test/ comparator product for pain relief 8.Changes from base line to 2 weeks in following laboratory parameter(s) for arthritis patients: a. C Reactive Protein and b.ESR 9. Subject’s overall satisfaction for pain relief and User perception 10. Number of patients requiring rescue medication 11.Changes from base line to 2 weeks post dose in Quality of life- Questionnaires Timepoint: Baseline and Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| To demonstrate safety and tolerability of study product by Clinical AEs (If any) Safety and tolerability evaluation criteria Adverse events and serious adverse events during the study period Brief clinical examination All the data will be compared between the test and the comparator.Timepoint: Baseline and Day 14 | — |
Countries
India
Contacts
Public ContactDr Gayathri Sivakumar
Ki3 Private Limited
Outcome results
None listed