Topical Tripterygium Wilfordii Gel for Treatment in Patients With Moderate Activity Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Twenty percent improvement in the American College of Rheumatology criteria
研究概览
简要总结
Tripterygium wilfordii Hook F (TwHF), a traditional Chinese herb, is widely used in China for treating Rheumatoid Arthritis (RA), but limited only for elderly RA patients because of its reproductive system toxicity. The investigators are inspired by Chinese external therapy, an immemorial therapy for thousands of years, and take its advantage to make TwHF topically in order to get an effective and safe treatment for active RA patients.
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
- •Documented diagnosis of rheumatoid arthritis, as defined by the American Rheumatism Association 1987 Revised Criteria.
- •Documented diagnosis of damp-heat syndrome according to Traditional Chinese Medicine.
- •Patients, men and women, must age from 18 to 65 years old.
- •Patients must have moderately active RA based on the criteria of the DAS-28 score from 3.2 to 5.
- •If patients are receiving Disease-modifying anti-rheumatic drugs (DMARDs), then the doses should have been kept stable for at least 12 weeks.
- •If patients are receiving non-steroidal anti-inflammatory drugs (NSAIDs) or orally Chinese herbal medicine, then the doses should have been kept stable for at least 4 weeks.
排除标准
- •Skin allergies or broken skin;
- •Taking TwHF agents, glucocorticoids and biological agents;
- •Female patients who are pregnant, breast-feeding or planed to be pregnant;
- •Subjects suffering serious hyperlipidemia, hyperglycemia, diabetes mellitus, cardiovascular diseases, gastrointestinal problems or liver and renal failure.
研究组 & 干预措施
topical TwHF gel group
Topical TwHF gel recipe composes Tripterygium wilfordii Hook F, Mangxiao (Mirabilite), Chuanxiong (Rhizoma Ligustici), Ruxiang (Olibanum), Moyao (M yrrh) (prescription proportion is 4:4:2:2:1).Each gel is 20 gram(g). TwHF gel is applied for 1st to 5th metacarpophalangeal joints, 1st to 5th proximal interphalangeal joints, wrists, knees and ankles 20g for 1 hour, once per day from week 0 through week 4 and 10g for 1 hour, once per day from week 5 through week 8.
干预措施: Topical tripterygium gel (Drug)
placebo group
Placebo recipe composes viscous agent which matches by the sucrose. The usage and dosage of topical TwHF and placebo are the same.
干预措施: Placebo gel (Drug)
结局指标
主要结局
Twenty percent improvement in the American College of Rheumatology criteria
时间窗: Week 4.
次要结局
- The changes of the 28-joint count Disease Activity Score (DAS28)(Week 4 and week 8.)
- The changes of Visual Analogue Scale (VAS) pain score(Week 1, 2, 3, 4, 5, 6, 7, and 8.)
- The change of knee articular cavity effusion as assessed by MSUS(Week 2, 4, and 8.)
- The change of knee bone erosion classification as assessed by MSUS(Week 2, 4, and 8.)
- Fifty percent improvement in the American College of Rheumatology criteria(Week 4 and week 8.)
- The change of knee synovitis classification as assessed by musculoskeletal ultrasound (MSUS)(Week 2, 4, and 8.)
- The change of knee synovial hyperplasia classification as assessed by MSUS(Week 2, 4, and 8.)
研究者
Quan Jiang
Chief, Rheumatology Department
Guang'anmen Hospital of China Academy of Chinese Medical Sciences