TCTR20200827001进行中（未招募）3 期
Efficacy and Safety of Benjakul Remedy Extract Capsule in Primary Osteoarthritis versus Naproxen (Clinical Trial Phase III)
Faculty of Medicine, Thammasat University0 个研究点目标入组 350 人开始时间: 2020年8月27日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 350
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
- 50 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1. Diagnosis of idiopathic OA knee according to clinical criteria of American College of Rheumatology
- •Knee pain + at least 3 of 6:
- •o Age > 50 years
- •o morning stiffness< 30 minutes
- •o bony tenderness
- •o bony enlargement
- •o no palpable warmth
- •2. Pain score according to numerical rating scale (while standing) not less than 3
- •3. Willing to participate
排除标准
- •1 History of hypesensitivity herbal and naproxen
- •2 History of lower extremity surgery within 6 months prior to screening
- •3 Treatment with other drugs potentially affecting bone or cartilage metabolism such as
- •o Chronic systematic corticosteroids
- •o Glucosamine or chondroitin sulphate within 15 day prior to screening
- •o Hyaluronate injection into the index knee within 6 months prior to screening
- •o Diacerin treatment within 12 months prior to screening
- •4 Chronic kidney disease eGFR < 60 ml min 1 73 m2
- •5 History of drug or alcohol abuse
- •6 history of peptic ulcer disease, hepatic or renal impairment AST or ALT above normal range GFR below 30 ml min 1 73 m2
研究者
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