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临床试验/ITMCTR2100004638
ITMCTR2100004638招募中1 期

Observation on the clinical curative effect of external application of Rebi ointment in treating rheumatoid arthritis (damp-heat syndrome) joint pain

Yunnan Provincial Hospital of Traditional Chinese Medicine/The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症

试验速览

阶段
1 期
状态
招募中
发起方

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. Patients meeting the ACR / EULAR diagnostic criteria for RA in 2010;
  • 2. Patients who meet the diagnostic criteria of traditional Chinese medicine (TCM) syndromes of Bi dampness heat obstruction syndrome;
  • 3. Subjects aged between 18 and 70, regardless of gender;
  • 4. For the subjects whose X-ray staging of the joints of both hands belongs to stage I and II, the joint function classification belongs to grade I, II and III;
  • 5. 2.6 < DAS28 < 5.1;
  • 6. Patients with at least pain or swelling of both wrists;
  • 7. Patients who use hormones, hormone suspects or biological agents need to stop taking drugs for more than 3 months;
  • 8. Subjects who did not use NSAIDs or topical analgesics at least one week before enrollment.
  • 9. The volunteers signed the informed consent.

排除标准

  • 1. Patients with other rheumatic immune diseases, such as systemic lupus erythematosus, Sjogren's syndrome, severe osteoarthritis, etc;
  • 2. Patients with serious diseases such as cardiovascular, lung, liver, gastrointestinal tract, kidney, hematopoietic system or tumor, or complicated with various acute and chronic infections or other infectious diseases (hepatitis, tuberculosis, etc.);
  • 3. Subjects with local skin damage, infection or injury of the joints;
  • 4. No response to methotrexate and leflunomide;
  • 5. Subjects with contraindications (pulmonary fibrosis, etc.) and allergic history of experimental drugs;
  • 6. History of alcohol abuse, drug abuse or neuropsychiatric disorders (epilepsy, depression, etc.);
  • 7. Pregnant or lactating women have a family planning in the near future;
  • 8. Subjects who are participating in clinical research of other drugs.

研究者

发起方
Yunnan Provincial Hospital of Traditional Chinese Medicine/The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine

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