CTRI/2025/01/079189RecruitingPhase 3 4
Myostaal Liniment Application as Add-on Therapy for Muscle Strengthening in Participants Suffering from Knee Osteoarthritis: An open-label, Randomized Clinical Study
Solumiks Herbaceuticals Limited2 sites in 1 country120 target enrollmentStarted: February 1, 2025Last updated:
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Recruiting
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Improvement in knee muscle strength by Push-pull Dynamometer
Study Overview
Brief Summary
Knee Osteoarthritis (OA) contributes to nearly 80 % of Global OA burden. Knee OA is estimated to affect 3.9% of rural Indians and 5.5% of urban Indians. The initiation , progression and severity of Knee OA have been associated with decreased muscular strength and alteration in joint biomechanics. excercises to strengthen the knee are a crucial part of the treatment to avoid surgery and maintain joint mobility. This present study is designed to evaluate the muscle stengthening effect of Myostaal Liniment application as an add on physiotherapy as compared to physiotherapy alone in patients suffering from Knee Osteoarthritis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 38.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
- •Patient with a previous history of no treatment or only conservative treatment.
- •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.
- •Patient who have Grades 1 and 2 in radiological findings based on Kellgren and Lawrence system for classification of osteoarthritis.
- •Patient willing to give written informed consent and willing to come for follow-up visits.
Exclusion Criteria
- •Participant with secondary arthritis or systemic inflammatory arthritis (rheumatoid arthritis, psoriatic arthritis, postinfection arthritis, metabolic arthritis, traumatic arthritis, or surgical joint replacement)
- •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.
- •Participant with a history of surgery or planning for surgery in the next 3 months.
- •Participant with intra-articular viscosupplementation (e.g., SynviscR) in affected knee joint in the past 6 months.
- •The participant with ongoing use of oral muscle relaxant or low-dose antidepressant medication for chronic pain management.
- •Participants with auto-immune disease, uncontrolled hypertension, uncontrolled diabetes mellitus (requiring a change in antidiabetic therapy or insulin injections), and chronic severe respiratory disease.
- •The participant with a history of clinically active renal, hepatic, and peptic ulcer disease.
- •Participant with a history of life-threatening cardiovascular and/or neurological events in the past 1 year.
- •The participant with a history of alcohol or drug abuse, or bleeding disorder.
Outcomes
Primary Outcomes
Improvement in knee muscle strength by Push-pull Dynamometer
Time Frame: at baseline and at the end of 60 days
Secondary Outcomes
- 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))
Investigators
Dr Asmita Wele
Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune
Study Sites (2)
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