NCT00503828已完成3 期
The Efficacy and Safety of Derris Scandens Benth Extract and Naproxen for Therapy of Patients With Knee Osteoarthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- WOMAC score
研究概览
简要总结
Derris Scandens Benth (family : Leguminosae) is a woody vine growing throughout Southeast Asia, including Thailand. The stem of D.Scandens has been widely use in Thai traditional medicine, foe example of myalgia. Previous study shown that D.Scandens Benth extract has the anti-inflammatory activity. Although NSAIDs are efficaciously in the treatment of osteoarthritis,but the GI side effect is still concerned. In this study we aim to investigate the efficacy and safety of D. Scandens Benth extract compared with Naproxen for therapy of patients with knee osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >=50 yr
- •Known case of primary knee osteoarthritis
- •WOMAC pain subscale (item1) >= 5
- •signed informed consent
排除标准
- •hypersensitive to NSAIDs
- •history of peptic ulcer or melena
- •unable to walk , i.e. patient with severe spinal stenosis, myocardial infarction
- •history of intra-articular injection of knee within 3 months
- •status post knee replacement
研究组 & 干预措施
naproxen
Active Comparator
Naproxen 500 mg/day for 4 weeks
干预措施: naproxen (Drug)
Derris Scandens Benth
Experimental
Derris Scandens Benth
干预措施: Derris scandens Benth extracts (Drug)
结局指标
主要结局
WOMAC score
时间窗: 2, 4 weeks
次要结局
- 6-minute walk, Quality of Life, adverse event(2, 4 weeks)
研究者
研究点 (1)
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