A prospective, randomized, comparative, parallel, 2-arm study to evaluate the efficacy and safety of a Myostaal liniment application as add on therapy for muscle strengthening in patients suffering from osteoarthritis of knee
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Improvement in knee muscle strength on basis of dynamometer readings
研究概览
简要总结
Osteoarthritis(OA) is the most prevalent form of arthritis in India and it is estimated toaffects over 15 million adults every year. Osteoarthritis continues to haveserious impact on the lives of elderly people but in the last few decades,Indians in the age-group of 30 to 50 years are falling prey to this disease. By2025, India is estimated to be the Chronic Disease Capital with 60 millionpeople suffering from arthritis.
Conventionaltreatments for OA include pain medication (nonsteroidal anti-inflammatory drugsand cyclooxygenase-2 inhibitors), exercises, hot and cold therapy,corticosteroid injections and eventually, surgery to repair the joint. Despiteconventional treatment, OA is often progressive and frequently leads to chronicpain and disability.3
Inosteoarthritis, NICE (National Institute of Health and Care Excellence)Guidelines, United Kingdom, recommends exercise as a core treatment,irrespective of age, comorbidity, pain severity or disability. Exercise shouldinclude local muscle strengthening and general aerobic fitness.
In AyurvedMassage is done with medicated oils like Mahanarayan Tel are widely used byAyurved practitioners to improve the tone of periarticular muscles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed case of Idiopathic knee osteoarthritis for minimum 1month and maximum 5 years according to clinical guidelines of American college of Rheumatology.
- •2.Patient having baseline knee joint pain more than 40 mm on Visual Analogue Scale (VAS) either at rest or on weight bearing activities (e.g. walking, standing, climbing staircase) during the preceding 24 hours.
- •Patients who have Grades 1 and 2 in radiological findings.
- •4.Patients willing to give written informed consent.
排除标准
- •Patient with secondary arthritis related to systemic inflammatory arthritis (including rheumatoid arthritis, psoriatic arthritis, post infectious arthritis and metabolic arthritis, traumatic arthritis or surgical joint replacement)
- •Patient on corticosteroid use: (a) oral corticosteroid within the previous 14 days.
- •(b) intramuscular corticosteroid within 30 days.
- •(c) intra-articular corticosteroid into the study knee within 90 days.
- •(d) intra-articular corticosteroid into any other joint within 30 days.
- •(e) topical corticosteroid at the site of application within 14 days; Or patient requiring systemic corticosteroids during the course of study.
- •Patient who has undergone or who is planning to undergo knee replacement surgery in next 3 months will be excluded from the study.
- •Patient who has underwent knee replacement surgery for the affected knee and who have undergone a knee arthroscopy within past 2 years.
- •Patient with intra-articular visco supplementation (e.g., SynviscR) in the affected knee joint in the preceding 6 months.
- •Patients with auto-immune disease, uncontrolled hypertension, Diabetes mellitus requiring insulin injections and chronic severe respiratory disease.
- •Patient with history of clinically-active renal, hepatic or peptic ulcer disease.
- •History of life threatening cardiovascular and /or neurological event in the past one year.
- •Patient with history of alcohol or drug abuse, bleeding disorder.
- •Patient having any severe active infectious disease requiring hospitalization.
- •Pregnancy or lactation.
- •Patient known to have allergy for any of ingredients of study medicine.
结局指标
主要结局
Improvement in knee muscle strength on basis of dynamometer readings
时间窗: at baseline and at the end of 90 days
次要结局
- Relief in symptoms of osteoarthritis of knee (pain, stiffness and physical function) on basis of WOMAC score(at baseline, 15 days, 30 days, 45 days, 60 days, 75 days, 90 days)
- Improvement in(1. 6 Minutes’ walk test,)