Evaluation of efficacy and tolerability of a fixed dose combination of Glucosamine sulphate and Omega 3 Fatty Acid For treatment of Painful Osteoarthritis of knee: An open, prospective, randomized three arm study.
试验速览
- 阶段
- 3 期
- 入组人数
- 210
- 试验地点
- 3
- 主要终点
- -Improvement in the WOMAC 21 (Western Ontario and McMaster Universities) Score (Sum total of subscale scores for Pain, Stiffness and Function deficit)
研究概览
简要总结
It a trial to evaluate efficacy and tolerability of a fixed dose combination of Glucosamine sulphate and Omega 3 Fatty Acid For treatment of Painful Osteoarthritis of knee. Its an open, prospective, randomized three arm study.The estimated sample size for three arm study is 180 anticipating a dropout rate of 15%, a total of 210 patients would be enrolled (70 in each arm).210 patients would be enrolled (70 in each arm).All medications to be administered by oral route. The study will be conducted at 3 centres all across the country. There are three arms in the study. Study arm is a combination Glucosamine and Omega three fatty acids versus plain Glucosamine versus plain Omega three fatty acids
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
入选标准
- •Patients of either sex above 25 years of age-Clinical diagnosis of primary Osteoarthritis (OA) of the knee (tibiofemoral joint) based on clinical and radiographic criteria.
- •i.e. patients at the time of enrollment in this study having mild to moderate unilateral or bilateral knee pain with or without morning stiffness of <30 minutes duration, and radiographic osteophytes with one or more of the following:?Marginal lipping?Narrowing of joint space?Sharpened articular margin?sclerosis i.e. damaged thickened or eburnated subchondral bone cysts-ARA Functional Class I, II, or III -Clinical symptoms of OA for at least 6 months prior to study entry-Patient ready to give informed consent.
排除标准
- •Patients having overt joint deformity -Traumatic joint pain.
- •Patients who require surgical intervention -History of Ischemic Heart Disease -Pregnant and lactating females -Those receiving corticosteroid treatment -Patients with H/O gastritis, peptic ulcer, bleeding ulcers.
- •Patients with known hepatic or renal impairment -Intra-articular injection of corticosteroids, hyaluronic acid or congeners into study joint with 12 months -Implementation of any other medical therapy for arthritis within 1 week prior to enrollment.
- •Patients with known hypersensitivity to any component of study drug.
- •Pregnant and lactating females -Patients with H/O drug/alcoholic abuse -Any other condition that, in the opinion of the investigator, does not justify the inclusion of the subject in the study.
结局指标
主要结局
-Improvement in the WOMAC 21 (Western Ontario and McMaster Universities) Score (Sum total of subscale scores for Pain, Stiffness and Function deficit)
时间窗: At the end of study period
次要结局
- -Reduction of concurrent use of rescue analgesic-Global Efficacy Assessment evaluated on a 5-point scale of Excellent, Good, Fair, Poor, & Worse(At the end of study period)