Efficacy and Safety of Xinfeng Capsule in the Treatment of Rheumatoid Arthritis (RA):A Randomized, Double-blind, Double-dummy, Multi-center Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 304
- 试验地点
- 3
- 主要终点
- ACR20 (American College of Rheumatology (ACR) criteria of 20% improvement in symptoms )
研究概览
简要总结
Bi Syndrome is one of Traditional Chinese Medicine（TCM）name, It means an obstruction in Chinese,and it refers the syndrome characterized by the obstruction of qi and blood in the meridians due to the invasion of external pathogenic wind,cold and dampness, manifested as soreness, pain, numb,etc. Bi Syndrome contains Rheumatoid arthritis(RA). RA is a chronic disease affecting more than 20 million people in the world.It is one of the most common forms of autoimmune disease. Xin'an Medicine is one of Traditional Chinese Medicine which originated from AnHui. Xinfeng Capsule developed according to the Xin'an medicine theory ,and it has long been adopted for treatment of rheumatoid arthritis (RA). The study is aimed to evaluate the effectiveness and safety of Xinfeng Capsule in the treatment of RA.
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, 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
- •Diagnosis of RA, classified by American Rheumatism Association 1987 revised criteria.
- •According with the Zheng diagnosis of Traditional Chinese Medicine.
- •age from 18 to 65 years.
- •For patients currently receiving non-steroidal anti-inflammatory drugs (NSAIDs): Treatment at a stable dose during last 4 weeks prior to screening，or Patients do not take NSAIDs at least 1 weeks prior to screening.
- •Patients not taking DMARDs at least 4 weeks prior to screening.
- •Patients taking corticosteroids (≤15mg prednisone or Equivalent) ≥4 weeks before entering the trial.
- •Patients agree to participate in this study and sign the informed consent form.
排除标准
- •Patients have received intra-articular or systemic corticosteroid injection within 4 weeks of screening.
- •Patients have high disease activity (DAS28-3 scores> 5.1).
- •Patients have diagnosed any other chronic inflammatory disease or connective tissue disease like sicca syndrome（SS）, systemic lupus erythematosus (SLE)etc;
- •Patients with sever diseases in Cardiovascular, brain, lung, liver, kidney and hematopoietic system ;
- •Patients who are pregnant or nursing mothers or Psychiatric patients.
- •Patients with active gastroduodenal ulcer or gastritis which caused by long-term use of NSAIDs;
- •The patient who has known hypersensitivity to trial medicine .
- •Patients have participated in other clinical trials within 4 weeks of screening.
研究组 & 干预措施
Xinfeng capsule & placebo
- Xinfeng capsule:Three each time, 3 times a day, Oral,for 3 months
- placebo(for leflunomide): 10 mg each time, 1 time a day, Oral,for3 months
干预措施: Xinfeng capsule (Drug)
leflunomide & placebo
- leflunomide :10mg each time, one time a day, by mouth,for 3 months
- placebo(for xinfeng capsule):Three each time, 3 times a day, Oral,for3 months
干预措施: leflunomide (Drug)
结局指标
主要结局
ACR20 (American College of Rheumatology (ACR) criteria of 20% improvement in symptoms )
时间窗: baseline,week4,week8,week12
ACR20 used for evaluating the efficacy of rheumatoid arthritis (RA).
次要结局
- Patterns based on Chinese medicine(CM)symptoms(baseline,week4,week8，week12)
- Life Quality Assessment(baseline,week12)
- ACR50 (American College of Rheumatology (ACR) criteria of 50% improvement in symptoms )(baseline,week4,week8，week12)
- ACR70 (American College of Rheumatology (ACR) criteria of 70% improvement in symptoms )(baseline,week4,week8，week12)
- Rheumatoid arthritis (RA) biomarkers(baseline, week12)
- x-rays of the hands and wrists(baseline,week12)
- Disease Activity Scale (DAS)28(baseline,week4,week8, week12)
研究者
Liu Jian
professor，Chief Physician
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine