Efficacy and Safety of Qingre Huoxue Comprehensive Therapy in the Treatment of Rheumatoid Arthritis (RA): A Randomized, Double-blind, Double-dummy, Multi-center Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 468
- 试验地点
- 1
- 主要终点
- The change from Baseline to week 24 in Disease Activity Score (DAS28)
研究概览
简要总结
This is prospective randomized, controlled study to evaluate the efficacy and safety of Qingre Huoxue comprehensive therapy in treating of patients with early Rheumatoid Arthritis (RA). The major outcome index is the change from baseline to week 24 in Disease Activity Score (DAS28), and minor outcome indexes include American College of Rheumatology (ACR)20/50/70, PRO score, Sharp score and OMERACT RAMRIS score. The adverse events at any time were recorded to evaluate the safety.
详细描述
Three arms were included in this study, and treatment with MTX and HCQ is defined as active comparator. Treatment of TCM，including Qingre Huoxue granule, Qingre Huoxue external preparation, MTX placebo and HCQ placebo, is defined as one experimental arm. Treatment of integrative medicine，including Qingre Huoxue granule, Qingre Huoxue external preparation, MTX and HCQ, is defined as another experimental arm.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with rheumatoid arthritis as determined by the 1987 ACR classification criteria.
- •Diagnosed with TCM dampness heat and blood stasis syndrome
- •The course of RA is not more than 5 years.
- •Swollen joint (SJC)≥2 and tender joint count(TJC)≥
- •Erythrocyte Sedimentation Rate（ESR）≥20 mm/hr
- •Patients who take disease-modifying antirheumatic drugs for at least 3 months on a stable dose, and retain the same treatment during the study.
- •Age 18-65 years with informed consent
排除标准
- •Patients with skin burst or allergies.
- •Patients with cancer or other malignant disease such as cardiovascular, hematopoietic, liver and kidney disease, and psychopath
- •Active or chronic infection, including HIV, hepatitis C virus, hepatitis B virus, tuberculosis
- •Previous treated with tripterygii, glucocorticoid or biologic disease-modifying antirheumatic drug (DMARD) in 3 months.
- •Previous treated with MTX or HCQ
- •Patients with retinopathy.
研究组 & 干预措施
Treatment of MTX and HCQ
Patients were treated with methotrexate (MTX), hydroxychloroquine (HCQ), oral Qingre Huoxue granule placebo and Qingre Huoxue external preparation placebo.
干预措施: Treatment of MTX and HCQ (Drug)
Treatment of TCM
Patients were treated with oral Qingre Huoxue granule, Qingre Huoxue external preparation, methotrexate placebo and hydroxychloroquine placebo.
干预措施: Treatment of TCM (Drug)
Integrative Medicine
The patients were treated with methotrexate, hydroxychloroquine, oral Qingre Huoxue granule and Qingre Huoxue external preparation.
干预措施: Integrative Medicine (Drug)
结局指标
主要结局
The change from Baseline to week 24 in Disease Activity Score (DAS28)
时间窗: 0 weeks, 12 weeks, 24 weeks
Disease Activity Score for 28-joint counts was based on the erythrocyte sedimentation rate(ESR) (DAS28-4\[ESR\])
次要结局
- The proportion of patients achieving ACR20/50/70(0 week, 12 weeks, 24 weeks)
- The number of adverse events(24 weeks)
- The change from baseline to week 24 in the score on the patient report outcome (PRO)(0 week, 12 weeks, 24 weeks)
- The change in Sharp score(0 week, 52 weeks)
- The change in OMERACT RAMRIS score(0 week, 24 weeks)
研究者
Quan Jiang
Director，Devision of Rheumatology
Guang'anmen Hospital of China Academy of Chinese Medical Sciences