NCT00889694Unknown2 期
Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis: a 12-Week, Multiple Centers, Randomized Double-Blind, Positive Drug and Placebo Controlled Clinical Trial
Sun Yat-sen University0 个研究点目标入组 80 人开始时间: 2008年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 主要终点
- ASAS20
研究概览
简要总结
This study is a 12-week, randomized, placebo and positive drug controlled clinical trial to investigate whether tripterygium capsule is effective and safe in treating patients with ankylosing spondylitis. The investigators expect that the tripterygium capsule is more effective than placebo and has few adverse effects.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Fulfill the ESSG criteria for SpA and not fulfill any criteria for the subtype including ankylosing spondylitis, psoriatic arthritis, reactive arthritis and inflammatory bowel disease associated arthritis.
- •Disease is in active status defined by BASDAI>=40mm.
- •DMARDs administration must be suspended for at least 4 weeks before screening. NSAIDs dose must be stable for at least 4 weeks before screening.
排除标准
- •Intra-articular injection of glucocorticoid within 3 months.
- •Previous history of heart failure, multiple sclerosis, chronic obstructive pulmonary disease, recurrent infection, lymphoma or other tumors.
- •Accompanied by fibromyalgia syndrome or other rheumatic diseases.
- •Female of pregnancy or breast-feeding.
- •Poor compliance or with mental diseases.
结局指标
主要结局
ASAS20
时间窗: 12th week
次要结局
- BASDAI20/50/70(12th week)
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