CTRI/2025/01/079189招募中Phase 3 4
Myostaal Liniment Application as Add-on Therapy for Muscle Strengthening in Participants Suffering from Knee Osteoarthritis: An open-label, Randomized Clinical Study
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Improvement in knee muscle strength by Push-pull Dynamometer
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 38.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Improvement in knee muscle strength by Push-pull Dynamometer
时间窗: at baseline and at the end of 60 days
次要结局
- 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))
研究者
Dr Asmita Wele
Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Effect of herbal supplement in improving Knee Osteoarthritis.CTRI/2025/03/082495CLS Pvt Ltd100
尚未招募
3 期
To Study Effectiveness Of Homoeopathic Medicines in 50 Millesimal Potency in treatment of Knee Osteoarthritis among adultsCTRI/2025/11/096859Dr Ganesh Jagdale32
已完成
不适用
Effects of Mulligan's Pain Release Phenomenon and Kaltenborn Mobilizations on Knee OsteoarthritisKnee OsteoarthritisNCT07402291Riphah International University44
尚未招募
不适用
Efficacy of LN21194 in improving Knee OsteoarthritisCTRI/2026/01/101526Laila Nutra Private imited80
尚未招募
2 期
Etodolac Nanogel as an Adjunct to Physiotherapy for Knee OsteoarthritisKnee OsteoarthritisNCT07308470Pharos University in Alexandria30