NCT01535417已完成3 期
A 12 Weeks, Randomized, Double-blind, Multi-centers, Phase III Study to Evaluate the Efficacy and Safety of Shinbaro Capsule Compared With Celebrex Capsule in Patients With Osteoarthritis of Knee
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
- 198
- 主要终点
- WOMAC change
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of 'Shinbaro Capsule', a new herbal anti-arthritic agent, in patients with osteoarthritis of the knee.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 35 and 80
- •diagnosed with Knee OA based on criteria of ACR and showed ont through I ~ III of Kellgren Stage on radiography
- •wuffered constantly with Knee OA for more than 6 months prior to begining the study
- •scored more than 30 on total WOMAC scale
排除标准
- •had other comorbid orthopedic disease
- •had OA of index knee from significant trauma or surgery
研究组 & 干预措施
GCSB
Experimental
干预措施: Shinbaro Capsule (Drug)
Celebrex
Active Comparator
干预措施: Celebrex (Drug)
结局指标
主要结局
WOMAC change
时间窗: Baseline, 12 weeks
WOMAC change
次要结局
- Adverse Events(12 weeks)
- 100mm Pain VAS on walking(Baseline, 12 weeks)
- PGART(12 weeks)
研究者
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