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.

Merck Limited0 个研究点目标入组 210 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

•-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

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