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

Authors
Category Primary study
Registry of TrialsITMCTR
Year 2024
INTERVENTION: Western medicine routine group:A: Methotrexate 10‐15mg qw PO B: Leflunomide 10‐20 mg qd po C: Tripterygium wilfordii polyglycoside tablets 10‐20 mg tid po New patients: choose one of the A, B, and C options 1 immunosuppressant was maintained before enrollment, and A+B, A+C, or B+C regimens could be selected after enrollment Two immunosuppressants were maintained before enrollment, and A+B+C regimens were selected after enrollment. Remarks: Non‐menopausal women are not treated.;Tibetan Medicine Characteristic Therapy Group:In addition to the conventional group of Western medicine, the following drugs are added: 1.Hour medication (1) Morning: Sezhu Tangnai Powders 2g qd po×12w;(2) Noon: Puga Kua Pills 2g qd po×12w;(3) Evening: Zhencai Nia Pills 2g qd po×12w;(4) Interval: Liechi Atang Powders 5g qd po×5d. 2. Women with postmenopausal syndrome, Weise Nia pills 2g qd po,up to 5 days. 3. Qingpeng ointment is applied externally, bid×3 weeks.; CONDITION: Rheumatoid arthritis PRIMARY OUTCOME: ACR20; SECONDARY OUTCOME: 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 Inde Xof the Health Assessment Questionnaire(HAQ‐DI);Doctor's VAS score for overall condition;Rheumatoid factors(RF);Patient pain VAS score; 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 enrollmen
Epistemonikos ID: 6b39de5ab61297bc74f3dc394a9d98c93514e7f5
First added on: Aug 28, 2024