Rheumatoid arthritis
Conditions
Interventions
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 o
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×12
(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.
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine(The Second Affiliated Hospital of Guangzhou University of Chinese Medicine)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR20; | — |
Secondary
| Measure | Time frame |
|---|---|
| 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; | — |
Countries
China
Contacts
Public ContactHe Xiaohong
Guangdong Provincial Hospital of Traditional Chinese Medicine(The Second Affiliated Hospital of Guangzhou University of Chinese Medicine)
Outcome results
None listed