Prospective, Multicentre, Randomized, Double-blind, Placebo-controlled Clinical Trial of Luo-Fu-Shan Plaster in the Treatment of Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- The changes of Visual Analogue Scale(VAS) pain score
研究概览
简要总结
The aim of this study is to assess the efficacy and safety of Luo-Fu-Shan Plaster in patients with Rheumatoid Arthritis.
详细描述
The investigators are inspired by Chinese traditonal herb, an therapy for thousands of years, and take its advantage to make Luo-Fu-Shan Plaster in order to get an effective and safe treatment for active RA patients. The study is a multicenter, randomized, double-blind, placebo-controlled trial.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged 18 to 75 years (time of get informed consent)
- •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.
- •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 glucocorticoids,more than 10 mg daily.
- •Female patients who are pregnant, breast-feeding or planed to be pregnant;
研究组 & 干预措施
Luo-Fu-Shan Plaster 10g
10g，once daily，4 weeks
干预措施: Luo-Fu-Shan Plaster (Drug)
Placebo
10g，once daily，4 weeks
干预措施: The placebo 10g (Drug)
结局指标
主要结局
The changes of Visual Analogue Scale(VAS) pain score
时间窗: Day 1 to Week 4
The changes of Visual Analogue Scale(VAS) pain score of global health status, the patient's assessment of pain on a visual analogue scale. The score their pain intensity in the most affected joint on a 0-10 cm Visual Analogue Scale Score (VAS), ranging from no pain (0) to extremely pain (10).
次要结局
- The changes of the Disease Activiyu Score (DAS28)(Day 1 to Week 4)
研究者
Quan Jiang
Director,Devision of Rhenumatology
Guang'anmen Hospital of China Academy of Chinese Medical Sciences