Observation on the clinical effect of external application of Yi medicine SISE ointment in the treatment of rheumatoid arthritis (wind cold dampness syndrome) joint swelling and pai
- Conditions
- Rheumatoid arthritis
- Registration Number
- ITMCTR2100004658
- Lead Sponsor
- Yunnan Hospital of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(1) According to the diagnostic criteria of ACR / EULAR in 2010;
(2) According to the diagnostic criteria of traditional Chinese medicine (TCM) syndrome type of Bi - wind cold dampness syndrome;
(3) The age range is 18-70 years old, regardless of gender;
(4) The X-ray staging of the joints of both hands belongs to stage I and II, and the joint function classification belongs to grade I, II and III;
(5) 6 < DAS28 < 5. 1;
(6) At least there was pain or swelling in both wrists;
(7) Patients who use hormones, hormone suspects or biological agents need to stop taking drugs for more than 3 months;
(8) Non steroidal anti-inflammatory drugs or topical analgesics were not used at least one week before enrollment.
(9) The volunteers signed the informed consent.
(1) Patients with other rheumatic immune diseases, such as systemic lupus erythematosus, Sjogren's syndrome, severe osteoarthritis, etc;
(2) Severe diseases such as cardiovascular diseases, lung diseases, liver diseases, gastrointestinal diseases, kidney diseases, hematopoietic system diseases or tumors, or acute and chronic infections or other infectious diseases (hepatitis, tuberculosis, etc.);
(3) The patients with local skin damage, infection or trauma of the joints were not cured;
(4) No response to methotrexate and leflunomide;
(5) Contraindications of experimental drugs (pulmonary fibrosis, etc.) and allergic history were found;
(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) We are participating in clinical research of other drugs.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain degree VAS score;Morning stiffness;TCM syndrome score;Number of joint swelling;DAS28 score;Number of joint tenderness;
- Secondary Outcome Measures
Name Time Method Erythrocyte Sedimentation Rate (ESR);Rheumatoid factor classification;Grip;Joint function classification;Semi-quantitative evaluation of wrist ultrasound;C reactive protein;Patient Outcome Clinical Report PRO Scale Score;Anti-cyclic citrullinated peptide antibody;