NCT02286453已完成2 期
Clinical Efficacy and Safety of Benjakul Recipe in Treating Primary Osteoarthritis of Knee Compared With Diclofenac (Clinical Trial Phase II)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
Efficacy and adverse effects of Benjakul recipe in Treating Primary Osteoarthritis of Knee Compared with Diclofenac. This study was designed as double blind, randomized controlled trial. Approval from the ethical committee of Human Research Ethics Committee of Thammasat University (No: 1 Faculty of Medicine)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary osteoarthritis of knee with grade I-III of Kellgren & Lawrence criteria
- •Not during breast feeding
- •Not during pregnancy with a good contraception
- •Volunteer have a normal Complete Blood Count laboratory, lipid profiles,liver function tests and renal funtion tests
- •Do not abuse drugs
- •Good cooperation
排除标准
- •History of peptic ulcer, Gastroesophageal reflux disease (GERD), heart disease, liver disease or kidney disease
- •History of allergy diclofenac or allergy herbal medicine
研究组 & 干预措施
1
Experimental
Benjakul
干预措施: Benjakul recipe (Drug)
2
Active Comparator
diclofenac
干预措施: diclofenac (Drug)
结局指标
主要结局
Pain score
时间窗: 28 days
Pain score from Visual analog scale
次要结局
- Pain score(28 days)
研究者
Patamaporn Rachawat
Piya Pinsornsak
Thammasat University
研究点 (1)
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