A Clinical Trial About the Efficacy and Safety of Kunxian Capsule in Treatment Patients With Early Ankylosing Spondylitis: a 12-week, Multi-center, Randomized, Double-blind, Active Drug and Placebo Compared Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- proportion of patients achieving ASAS20 response
研究概览
简要总结
This is a prospective randomized controlled study to evaluated the efficacy and safety of kunxian capsule in treating of patients with early ankylosing spondylitis (AS). The major outcome index is proportion of patients achieving ASAS20 response at week12, and minor outcome indexes include ASAS50 and ASAS70, BASDAI20,BASDAI50 and BASDAI70. The adverse events at any time were recorded to evaluate the safety.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •16 to 65 years old, having signed the informed consent;
- •fulfill the ESSG criteria for diagnosis of SpA; not fulfill the 1984 modified NewYork criteria for AS;
- •BASDAI score more than 4;
- •stop taking DMARDs for at least 4 weeks;
- •NSAIDs dosage has been stable for at least 4 weeks;
排除标准
- •Intra-articular injection of cortisone within 3 months.
- •History of heart failure, multiple sclerosis, COPD, lymphoma or other tumors;
- •Accompanied by fibromyalgia or other rheumatic diseases;
- •Female of pregnancy or breast feeding;
- •History of mental disease and poor compliance.
- •History of drug abuse or alcoholism.
研究组 & 干预措施
Sulfasalazine
Sulfasalazine is a drug in treatment RA, AS and ulcerative colonitis. In this study, Sulfasalazine is used to act as an active comparator to access the efficacy of kunxian capsule.
干预措施: kunxian capsule (Drug)
placebo
The placebo capsule was used to be a comparator of kunxian capsule
干预措施: kunxian capsule (Drug)
结局指标
主要结局
proportion of patients achieving ASAS20 response
时间窗: 12th week
次要结局
- proportion of patients achieving BASDAI20/50/70 response(12th week)
研究者
Gu Jieruo
Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University
Sun Yat-sen University