TCTR20171123002已完成2 期
Clinical Efficacy and Safety of Innovated Cream from Thai Medicinal Plants (Garcinia/Arthrinox/Bim A) Versus Diclofenac Gel in Symptomatic Treatment of Osteoarthritis of Knee
Department of Pharmacology, Faculty of Medicine, Chiang Mai University0 个研究点目标入组 200 人开始时间: 2017年11月23日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 45 Years 至 0 N/A (No limit)（—）
- 性别
- All
入选标准
- •a) An out-patient, aged ≥ 45 years;
- •b) Unilateral or bilateral knee OA according to the criteria of ACR: knee pain, radiographic osteophytes, and at least 1 of the following 3 items: age > 50 years, morning stiffness not more than 30 minutes in duration, or crepitus on motion. The symptoms must be present for at least 3 months;
- •c) VAS of knee pain between 35-75 point (out of 100) after stopping using their usual analgesic or NSAIDs for, at least, 7 days;
- •d) Able to walk; and
- •e) must sign the written consent forms to participate in the study.
排除标准
- •a)Underlying inflammatory arthropathy, such as rheumatoid arthritis and gout;
- •b)Hyperuricemia (uric acid > 9 mg/dL);
- •c)Plan to undergo surgery in near future;
- •d)Recent injury in the knee affected by OA;
- •e)History of intra-articular corticosteroid injection within the last 3 months;
- •f)Hypersensitivity to NSAIDs or herbs used in this study;
- •g)Use of other NSAIDs or analgesic drugs;
- •h)Acute OA attack (inflammation, edema, redness, warmth);
- •i)Knee joint effusion;
- •j)Continuing use of symptomatic slow-acting drugs for OA (SYSDOA) [e.g., glucosamine sulphate, chondroitin sulphate, diacerein, and hyaluronan] for less than 4 months or stop using these drugs for less than 6 months;
- •k)Concomitant skin disease at the application site;
- •l)Use of another topical product at the application site;
- •m)Pregnancy or lactation;
- •n)Malignant tumor; or
- •o)Clinically significant abnormalities in blood chemistry and hematology:
- •ï‚§Hemoglobin < 9 g/dL
- •ï‚§White blood cells < 4,000 per cu. mm.
- •ï‚§Platelets < 100,000 per cu. mm.
- •ï‚§Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase more than 2 times of the upper limit of normal
- •ï‚§Estimated glomerular filtration rate < 45 mL/min per 1.73 m2 as of the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
研究者
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