A randomized controlled trial and promotion study of Tibetan medicine specialty therapy for the treatment of rheumatoid arthritis based on Zelen's desig

Not Applicable

Conditions: Rheumatoid arthritis

Registration Number: ITMCTR2024000072

Lead Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine(The Second Affiliated Hospital of Guangzhou University of Chinese Medicine)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Age between 18 and 75 years old (inclusive), male or female;
2. Those who meet the diagnostic criteria of rheumatoid arthritis of Western medicine at the time of screening;
3. Meet the Tibetan medicine Changzhong cold syndrome differentiation standards during screening;
4. Consistent with the diagnosis of rheumatoid arthritis (2.6= baseline DAS28 score =5.1) in the active stage of moderate and low disease at screening;
5. Voluntarily sign the informed consent form;
6. Use of traditional disease-modifying antirheumatic drugs (DMARDs) and tripterygium wilfordii preparations before enrollment, and the types are limited to 2 types;
7. Have not received DMARDs treatment other than leflunomide, methotrexate, tripterygium, etc. within 1 month before enrollment;
8. The use of non-steroidal anti-inflammatory drugs or other analgesics for the treatment of RA before enrollment must have been on a stable dose for at least 1 week before enrollment, and the dose of medication remains unchanged after enrollment;
9. Oral glucocorticoids before enrollment, the dose must be stabilized to a dose equivalent to ?10mg/d prednisone for at least 4 weeks before enrollment, and the dose must be maintained unchanged after enrollment.

Exclusion Criteria

1. Patients with other rheumatic immune diseases;
2. Patients with severe heart and cerebrovascular diseases, kidney lesions, and liver lesions;
3. Patients with serious infections, tumors, and infectious skin diseases;
4. Those with advanced deformity, disability, and loss of labor force in rheumatoid arthritis;
5. Patients with obvious skin lesions and ulcers at the site of joint lesions;
6. Those who are allergic to the test drug;
7. Those who are pregnant, or lactating women, or have the possibility of conception but fail to take effective contraceptive measures during the test;
8. Subjects with severe organic lesions, mental awareness disorders or other reasons that cannot cooperate with treatment;
9. Those who have used biological agents or small molecule targeted drugs in the past 3 months;
10. Those who have participated in other interventional clinical trials in the past 1 month or are participating in them;
11. Patients with interstitial lung lesions.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ACR20;

Secondary Outcome Measures

Name	Time	Method
VAS score of patient for overall condition;Tibetan Medicine Symptom Grading Scale Scores;Tender joint count (TJC);Swollen joint count (SJC);C-reactive protein(CRP);Erythrocyte sedimentation rate(ESR);DAS28-CRP score;Disability Index of the Health Assessment Questionnaire(HAQ-DI);Doctor's VAS score for overall condition;Rheumatoid factors(RF);Patient pain VAS score;