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

Phase 1

Recruiting

• Conditions: Rheumatoid Arthritis

• Registration Number: ITMCTR2100004638
• Lead Sponsor: Yunnan Provincial Hospital of Traditional Chinese Medicine/The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TCM syndrome score;Number of joint swelling;Curative effect of Chinese medicine disease;Morning stiffness;DAS28 score;Number of joint tenderness;Pain degree VAS score;

Secondary Outcome Measures

Name	Time	Method
Anti-cyclic citrullinated peptide antibody;Semi-quantitative evaluation of wrist ultrasound;Joint function classification;VAS score for the overall condition of the disease assessed by the patient;Patient Outcome Clinical Report PRO Scale Score;Grip;Rheumatoid factor classification;ACR20 compliance ratio;Erythrocyte Sedimentation Rate ;VAS score for the overall condition of the disease as assessed by the investigator;C reactive protein;