A Randomized Controlled Study to Determine the Effects and Safety of Topical Compound Tripterygium Wilfordii Hook F in Patients With Active Rheumatoid Arthritis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 主要终点
- ACR20 criteria
研究概览
简要总结
Rheumatoid Arthritis (RA) is an autoimmune disease that results in a chronic inflammatory disorder that may affect many synovial joints, and may cause serious disability. It has been confirmed that Tripterygium wilfordii Hook F has effects of anti-inflammatory, immunosuppressive and cartilage protection. This is a prospective randomized controlled study to evaluated the efficacy and safety of external application with compound Tripterygium wilfordii Hook F in treating of patients with rheumatoid arthritis (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
- Double (Participant, 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
- •Documented diagnosis of rheumatoid arthritis, as defined by the American Rheumatism Association 1987 Revised Criteria or European League Against Rheumatism criteria (2009).
- •Patients must have moderately to severely active RA,and the DAS-28 score should be from 3.2 to 5.
- •If taking disease modifying antirheumatic drug (DMARDs)(e.g.Methotrexate), subject must have been on a stable dose for ≥ 3 months prior to randomization.
- •If taking non-steroidal anti-inflammatory drugs (NSAIDs), subject must have been on a stable dose for ≥ 4 weeks prior to randomization.
- •16 to 65 years old, having signed the informed consent.
排除标准
- •Patients who have skin burst or allergies.
- •Patients with sever diseases in Cardiovascular, brain, lung, liver, kidney and hematopoietic system.
- •Patients who have been treated by tripterygium, hormones or biological agents.
- •Patients who have not been treated by DMARDs before.
- •Patients who are unwilling to comply with all study procedures.
研究组 & 干预措施
Topical Tripterygium group
Patients were treated with topical compound tripterygium for 1 hour, twice per day. Area dosages were as followed that each 1st to 5th metacarpophalangeal joints (MCPJs), 1st to 5th proximal interphalangeal joints (PIPJs) and wrist was 3 ml, each elbow and ankle was 5 ml, each knee was 10 ml.
干预措施: Topical compound tripterygium (Drug)
Topical Placebo group
Patients were treated with topical placebo for 1 hour, twice per day. The dosage was the same as the topical tripterygium group.
干预措施: Placebo (Drug)
结局指标
主要结局
ACR20 criteria
时间窗: Week 4
To meet the criteria, a patient must have 20% or greater improvement in both tender and swollen joints (28 tender and 28 swollen joints were assessed) and 20% or greater improvement in 3 or more of the following: the physician's or patient's assessment of global health status, the patient's assessment of pain on a visual analogue scale, the patient's assessment of function using a modified version of the Health Assessment Questionnaire (HAQ), and the ESR or serum C-reactive protein (CRP) level.
次要结局
- 28-joint count Disease Activity Score (DAS28)(Baselin and week 4)
- ACR50 criteria(Week 4)
研究者
Quan Jiang
director
Guang'anmen Hospital of China Academy of Chinese Medical Sciences