active stage of rheumatoid arthritis
Conditions
Interventions
test group:Jiawei Qingluo granules, 1bag, 2 times a day
placebo group:Jiawei Qingluo granules simulator, 1 bag, 2 times a day.
Sponsors
Yijishan Hospital, Wannan Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for ACR/EULAR(2010); (2)meets the standard of TCM dampness-heat obstruction syndrome differentiation; (3)DAS28(ESR)>3.2 or DAS28(CRP)>3.2; (4) The age ranges from 18 to 65 years old, regardless gender; (5)Have not used NSAIDs for at least 1 week; Or if used, the dose has been stable for at least 4 weeks; (6)Have been treated with methotrexate (MTX) for at least 12 weeks and keep the dose stable (7.5-20 mg/ week) for 4 weeks; (7)Have not used medium or short-acting hormones for at least 1 week or long-acting hormones for at least 2 weeks; Or if you have received prednisone (=10mg/ day) or equivalent hormone therapy, the dose should be stable for at least 30 days before entering the study and maintained during subsequent therapy; (8).Signed an informed consent form.
Exclusion criteria
Exclusion criteria: (1)Patients with other inflammatory joint diseases or autoimmune diseases, such as knee osteoarthritis, gouty arthritis, psoriatic arthritis, reactive arthritis and other connective tissue diseases caused by arthritis, systemic lupus erythematosus, Sjogren's syndrome, myositis or dermatomyositis; (2)Patients with a history of hematological diseases; (3)Patients complicated with other malignant tumors, cardiovascular, cerebrovascular, liver, kidney, endocrine system and other serious diseases; (4)Use of anti-rheumatic drugs or biologic agents other than methotrexate (MTX) to improve the condition: use salazopyridine, hydroxychloroquine, penicillamine, cyclosporin, azathioprine, cyclophosphamide, eramodine, etc., within 4 weeks or not more than 5 half-lives; Use of herbal preparations (including tripterygium wilfordis preparations, total glucosides of paeony, sinomenine and other proprietary Chinese medicines and/or Chinese herbal medicines, etc.) within 4 weeks; Use flunomide within 8 weeks; Biologics, such as TNF-a inhibitors (including etanercept, infliximab, Adalimumab, Gorimumab, Becselizumab, TNF- receptor antibody fusion protein, etc.), IL-1 antagonists, IL-6 antagonists, abacil, etc., were used within 24 weeks; (5)Joint function grade 1 (6)X-ray stage ?; (7)Cr exceeding the upper limit of normal value or any item of ALT or AST exceeds 1.5 times the upper limit of normal value; (8)WBC < 3.0×109/L or Platelet < 90×109/L; (9)Women who plan to become pregnant during pregnancy or within half a year, breastfeeding women (10)Persons with mental illness or cognitive impairment; (11)Allergic to or allergic to the known ingredients of the experimental drug; (12)Suspected or confirmed to have a history of alcohol addiction or drug abuse; (13)Participants who participated in other clinical trials within 30 days prior to screening; (14)Participants considered inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects with ACR 20, ACR 50, ACR 70 after 12 weeks of treatment;; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects who reached ACR 20, ACR 50 and ACR 70 after 4 and 8 weeks of medication;;DAS28 (CRP) =2.6, DAS28 (ESR) after 4, 8 and 12 weeks of medication Proportion of subjects =2.6, DAS28 (CRP) > 2.6 and =3.2, DAS28 (ESR) > 2.6 and =3.2;;The disappearance rate of single symptom or sign after medication;; Therapeutic effect of TCM syndromes for 4, 8 and 12 weeks of medication;;Changes in HAQ-DI scores from baseline after 4, 8, and 12 weeks of treatment;;Changes in joint function grade from baseline at 4, 8, and 12 weeks of medication;;Changes of ESR, CRP, RF and anti-CCP antibody compared with baseline after 4, 8 and 12 weeks of administration;;Use of acetaminophen tablets.;Changes of pain VAS scores from baseline after 4, 8, and 12 weeks of treatment; | — |
Countries
China
Contacts
Public ContactLi Yan
Department of Traditional Chinese Medicine,Yijishan Hospital, Wannan Medical College
Outcome results
None listed