ITMCTR2100004644招募中1 期
Clinical observation on the treatment of joint swelling and pain due to the Fengtabuzu syndrome of RA by Dai medicine Longmengshahousan
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 70(—)
- 性别
- All
入选标准
- •(1) Meet the 2010 ACR/EULAR DIAGNOSTIC criteria for RA;
- •(2) It conforms to the diagnostic criteria of Fengtabuzu syndrome;
- •(3) Between the ages of 18 and 70, regardless of gender;
- •(4) the hands joint X-ray stage I and II, joint function class I and II, III;
- •(5) 2.6 < DAS28 < 5.1;
- •(6) Pain or swelling of at least two wrists;
- •(7) Patients who use hormones, hormone-suspected substances or biological agents need to stop taking drugs for more than 3 months;
- •(8) No non-steroidal anti-inflammatory drugs or topical analgesics were used at least 1 week before enrollment.
- •(9) Voluntary subjects signed informed consent.
排除标准
- •(1) Patients with other rheumatic immune diseases, such as systemic lupus erythematosus, Sjogren's syndrome, and severe osteoarthritis;
- •(2) Complicated with cardiovascular, pulmonary, liver, gastrointestinal, kidney, hematopoietic system or tumor, or complicated with various acute or chronic infections or other infectious diseases (hepatitis, tuberculosis, etc.);
- •(3) Local skin damage, infection or trauma of the tested joint is not healed;
- •(4) Those who did not respond to the treatment of methotrexate or leflunomide;
- •(5) A history of contraindications to experimental drugs (pulmonary interstitial fibrosis, etc.) and allergies;
- •(6) A history of alcoholism, drug addiction or neuropsychiatric disorders (epilepsy, depression, etc.);
- •(7) Pregnant or lactating women who have recently had family planning;
- •(8) Participating in other drug clinical studies.
研究者
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