Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
None listed
Sponsors
Solumiks Herbaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosed cases of Idiopathic Knee Osteoarthritis (unilateral) for minimum 1 month and maximum 5 years according to the clinical guidelines of the American College of Rheumatology. 2. Patient with a previous history of no treatment or only conservative treatment. 3. Patient having baseline knee joint pain more than 4 on NPRS Scale either at rest or on weightbearing activities (e.g., walking, standing, climbing staircase) during the preceding 24 hours. 4. Patient who have Grades 1 and 2 in radiological findings based on Kellgren and Lawrence system for classification of osteoarthritis. 5. Patient willing to give written informed consent and willing to come for follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Participant with secondary arthritis or systemic inflammatory arthritis (rheumatoid arthritis, psoriatic arthritis, postinfection arthritis, metabolic arthritis, traumatic arthritis, or surgical joint replacement) 2. Participants on NSAIDs and Corticosteroids (Topical corticosteroid application in last 14 days, Oral corticosteroid in last 14 days, intramuscular corticosteroid in last 30 days, intraarticular corticosteroid into the knee in last 90 days, intraarticular corticosteroid in any other joints in last 30 days); or participant requiring systemic corticosteroid during the study course. 3. Participant with a history of surgery or planning for surgery in the next 3 months. 4. Participant with knee replacement surgery and knee arthroscopy in the past 2 years. 5. Participant with intra-articular viscosupplementation (e.g., SynviscR) in affected knee joint in the past 6 months. 6. The participant with ongoing use of oral muscle relaxant or low-dose antidepressant medication for chronic pain management. 7. Participants with auto-immune disease, uncontrolled hypertension, uncontrolled diabetes mellitus (requiring a change in antidiabetic therapy or insulin injections), and chronic severe respiratory disease. 8. The participant with a history of clinically active renal, hepatic, and peptic ulcer disease. 9. Participant with a history of life-threatening cardiovascular and/or neurological events in the past 1 year. 10. The participant with a history of alcohol or drug abuse, or bleeding disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in knee muscle strength by Push-pull DynamometerTimepoint: at baseline and at the end of 60 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate the change in WOMAC Index on WOMAC (Modified-CRD Pune version) from baseline to Day 60 with Myostaal Liniment application as an add-on to physiotherapy as compared to physiotherapy alone in participants suffering from Knee Osteoarthritis. 2. To evaluate the change in distance covered in Six-Minute Walk Test (6MWT) 3. To evaluate the change in Single Leg Stance Test 4. To compare the number of participants showing adverse events if any. Timepoint: at baseline and at the end of 60 days | — |
Countries
India
Contacts
Public ContactDr Sanjivani Kamble
Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune
Outcome results
None listed