Multicentric, Open label, Randomized, Parallel-group, Active-controlled Clinical trial of the Fixed Dose Combination of Glucosamine 750 mg , Diacerein 50 mg and Aceclofenac100 mg In patients with osteoarthritis of knee joint.

M/S Jenburkt Pharmaceuticals Ltd.Nirmala Apartments,93, Jayprakash Road, Andheri (West),Mumbai - 400 058. India.4 个研究点分布在 1 个国家目标入组 200 人开始时间: 2010年7月15日最近更新: 2013年5月2日

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 200
试验地点: 4
主要终点: Primary parameters:1) Pain relief by Visual Analogue scale of 100 millimeters ( VAS)2. Macgill Questionaire for Pain.3. Clinical examination for joint pain, stiffness,tenderness and swellings.4. The range of movement extension by Long-arm Goniometer.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a randomised, open label, multicentric trial to compare the efficacy, tolerability and safety of fixed dose combination of " Glucosamine 750 mg, Diacerine 50mg, Aceclofenac 100 mg Vs Diacerine 50 mg and Aceclofenac 100 mg in patients with Osteoarthritis of knee joint that will be conducted in four centres in India.

研究设计

分配方式: Computer generated randomization
盲法: Open Label

入排标准

入选标准

•All the patients with dully filled Informed Consent Forms ( ICF).Age : 35 to 40 years.Sex : Both male and female.The patients with radiologically defined symptoms of osetoarthritis established diagnosis of osteoarthritis already on analgesic treatment with NSAID ( diclofenac sodium, , Aceclofenac, nimesulide, Naproxen ) not having significant pain relief in terms of pain and disability.

排除标准

•Patients with advance disease such as :* Patients with secondary arthritis such as infective, tubercular or psoriatic arthritis.* Patients who had arthroplasty.* Patients having undergone arthroscopic washout of knee joint.* Patients with concomittant diseases such as malignancy, HIV.* Pregnancy nd lactation.

结局指标

主要结局

Primary parameters:1) Pain relief by Visual Analogue scale of 100 millimeters ( VAS)2. Macgill Questionaire for Pain.3. Clinical examination for joint pain, stiffness,tenderness and swellings.4. The range of movement extension by Long-arm Goniometer.

时间窗: 30 days.

次要结局

secondery parameters :1. Quality of Life ( European Q5D)2. Physician's Global Assessment - 1 to 5 ( Very poor, Poor, Fair, Good and excellent.)(30 days.)

研究者

发起方

M/S Jenburkt Pharmaceuticals Ltd.Nirmala Apartments,93, Jayprakash Road, Andheri (West),Mumbai - 400 058. India.

研究点 (4)

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