RA(rheumatoid arthritis)
Conditions
Interventions
The test drug group:Qiwei tongbi Oral Liquid, for oral use. Take 1 capsule each time, 3 times a day. It is recommended to take it after meals. Sulfosalicylic Acid Hydroxychloroquine Tablets, as a simu
Positive drug group:Sulfosalicylic Acid Chloroquine Tablets, for oral use. Take 0.2 g each time, twice a day
Qiwei tongbi Oral Liquid Simulant, for oral use. Take 1 vial each time, three times a day.
placebo group:Qiwei tongbi Oral Liquid Simulant, for oral use. Take 1 capsule each time, 3 times a day
Sulfosalicylic Acid Hydroxychloroquine Tablets Simulant, for oral use. Take 0.2 g each time, twice a day.
Sponsors
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Age: 18 to 70 years old, gender not restricted; (2) Meets the Western medical diagnostic criteria for rheumatoid arthritis; (3) Meets the diagnostic criteria for the syndrome of liver-kidney deficiency in traditional Chinese medicine and the syndrome of rheumatism blocking the meridians; (4) Meets the criteria for low/moderate disease activity, that is, 2.6 < DAS 28 (CRP or ESR) = 5.1; (5) If currently receiving prednisone (prednisolone) (= 10 mg/d) or equivalent hormone treatment, the dose before entering the study must be stable for at least 30 days and the dose and usage during the study must remain unchanged; if not using, then at least 1 week has passed without using medium or short-acting hormones or 2 weeks without using long-acting hormones; (6) If before enrollment, is receiving traditional synthetic disease-modifying antirheumatic drugs (csDMARDs) (such as methotrexate tablets, sulfasalazine, leflunomide, penicillamine, azathioprine, cyclosporine, cyclophosphamide, elavermod, rhubarb total glycosides, etc.) treatment, the medication duration must be at least 12 weeks and the dosage must be stable; (7) Before enrollment, discontinued 5 half-lives of biologic DMARDs, such as tumor necrosis factor (TNF)-a inhibitors (etanercept, infliximab, adalimumab, golimumab, pezetilizumab, recombinant human type II tumor necrosis factor receptor-antibody fusion protein, etc.), interleukin (IL)-1 antagonists (anakinra), IL-6 antagonists (tocilizumab), T cell inhibitors (abatacept), targeting synthetic DMARDs, JAK inhibitors (tofacitinib, baricitinib, upadacitinib), etc.; discontinued 5 half-lives of hydroxychloroquine (see Appendix 5); (8) Can understand the procedures and methods of this clinical study, voluntarily participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Those with other inflammatory joint diseases or autoimmune disorders, such as knee osteoarthritis, gouty arthritis, psoriatic arthritis, reactive arthritis, and other joint diseases caused by connective tissue disorders, systemic lupus erythematosus, Sjogren's syndrome, myositis or dermatomyositis, etc.; (2) Those with severe diseases in the cardiovascular, brain, liver, lung, kidney, hematopoietic system, endocrine system, etc., patients with malignant tumors, patients with mental disorders; (3) Those with a history of suicidal behavior and mental disorders, a history of psoriasis, a history of hypoglycemia, a history of macular eye disease or retinal lesion, patients with porphyria, patients with glucose-6-phosphate dehydrogenase deficiency, rare genetic disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption; (4) Those whose chest CT examination indicates active pulmonary infection, interstitial lung disease, or suspected pulmonary malignancy; (5) White blood cell 1.5 times the upper limit of normal; serum creatinine (Scr) > upper limit of normal; (6) The results of 12-lead electrocardiogram examination, as determined by the investigator, are judged as abnormal and have clinical significance, and are judged to affect the safety of the subjects or are not suitable for using hydroxychloroquine; (7) Those with joint function grade IV; (8) Those with X-ray stage IV; (9) Those who have used traditional Chinese medicine, herbal powder formulas, or Chinese herbal decoctions for the treatment of rheumatoid arthritis within 2 weeks before enrollment; (10) Those suspected or confirmed to have a history of alcohol or drug abuse; (11) Those who are allergic to the components of the study drug or to 4-aminocyclohexyl compounds or have an allergic constitution (such as allergy to two or more drugs or foods); (12) Male subjects and female subjects with reproductive capacity who do not want or cannot adopt effective contraceptive measures during the study period; pregnant women, lactating women, or those who have a fertility requirement within 6 months after the last medication; (13) Those who have participated in other drug clinical trials within 30 days before screening; (14) Other situations that the investigator deems inappropriate for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects who achieved an ACR (American College of Rheumatology) 20 response; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients achieving ACR (American College of Rheumatology) 50 and ACR (American College of Rheumatology) 70 criteria;The proportion of patients achieving ACR (American College of Rheumatology) 20, ACR 50, and ACR 70;;The proportion of patients with low/moderate disease activity who achieved disease remission, that is, patients with DAS ( ?Disease Activity Score )28 (C-reactive protein,CRP) = 2.6 or DAS( ?Disease Activity Score ) 28 (Erythrocyte Sedimentation Rate, ESR) = 2.6;The proportion of patients with moderate disease activity who achieved low disease activity, that is, 2.6 < DAS ( ?Disease Activity Score ) 28(C-reactive protein,CRP) = 3.2 or 2.6 < DAS( ?Disease Activity Score ) 28 (Erythrocyte Sedimentation Rate, ESR) = 3.2;;The change in the number of joint tenderness compared to the baseline;The change in the number of swollen joints compared to the baseline;The change in the subjects' pain assessment (on a Visual Analogue Scale from 0 to 100 mm) compared to the baseline;;The overall assessment of disease activity by the subjects (on a Visual Analogue Scale of 0 to 100 mm) compared to the baseline;;The overall assessment of disease activity by the researchers ( Visual Analogue Scale, ranging from 0 to 100 mm) compared with the baseline changes;The change in the HAQ-DI score (a health assessment questionnaire for patients with disabilities) compared to the baseline;;The changes in joint function compared to the baseline;Changes in Erythrocyte Sedimentation Rate and C-reactive protein compared to the baseline;Changes from the baseline in Rheumatoid Factor and Anti-Citrullinated Peptide Antibody;The change in traditional Chinese medicine syndrome scores compared to the baseline; | — |
Countries
China
Contacts
Public ContactLin Changsong
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Outcome results
None listed