Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
None listed
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients with age between 40-70 years 2. Clinically diagnosed and radiologically confirmed mild to moderate (KL grade II & III) symptomatic cases of OA of knee joints 3. Onset of symptom duration greater than or equal to 6 months at the time of screening 4. A score of greater than or equal to 9 on the 20-point Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale at baseline 5. Greater than or equal to 5 score on 10-point visual analogue scale (VAS) for pain at baseline 6. Willing to give consent for participating in the study
Exclusion criteria
Exclusion criteria: 1. Patients having severe (KL grade IV) and disabling arthritis in targeted or contralateral knee joint 2. Patients with radiologically abnormal knee alignment 3. Those who are suffering from skin related problem at local sites of drug application which may affect drug application 4. Patients with history of HIV, Peripheral vascular diseases 5. Those who are on treatment with immuno-suppressive drugs and biologicals 6. Patients with history of Chikungunya, Dengue, or other viral infections in the past six months 7. Pregnant and lactating women 8. Any condition which in the opinion of investigator will place the subject at risk or will influence the conduct of study or interpretation of results 9. Diagnosed cases of Rheumatoid arthritis (RA factor positive) and Gouty arthritis (Serum Uric acid greater than UNL) 10. Patient requiring any systemic analgesic for other conditions which can affect the outcome of study drug 11. Patient on systemic corticosteroid therapy 12. Known case of history of allergy with NSAIDs or test drug 13. Patients with BMI greater than or equal to 35 kg/m2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in WOMAC score- Pain, WOMAC score- Stiffness, WOMAC- Functional TotalTimepoint: Baseline/Screening Week 1 Week 2 Week 3 Week 4 Week 6 (post intervention) Week 8 (post intervention) Week 12 (post intervention) | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in range of motion (goniometry)Timepoint: Baseline/Screening Week 1 Week 2 Week 3 Week 4 Week 12 (post intervention);Changes in Quality of life at the end of intervention and at the end of post intervention as compared to baseline using Osteoarthritis Knee and Hip Quality of Life (OAKHQoL) questionnaireTimepoint: Baseline Week 4 Week 12 (post intervention);To determine extent of use of rescue medicines in the both the group during the studyTimepoint: Week 1 Week 2 Week 3 Week 4 Week 6 (post intervention) Week 8 (post intervention) Week 12 (post intervention) | — |
Countries
India
Contacts
Public ContactDr Harsha Hegde
ICMR National Institute of Traditional Medicine Belagavi
Outcome results
None listed