Rheumatoid arthritis
Conditions
Interventions
Experimental group:Qiwei Tongbi oral liquid + XuanQitongbi capsule simulator + Methotrexate tablets
Positive drug group:Xuanqi Tongbi capsule + Qiwei Tongbi oral liquid simulator + Methotrexate tablets
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) 18= age =70 years old gender is not limited; (2) Meet the Western diagnostic criteria for rheumatoid arthritis; (3) In line with TCM liver and kidney deficiency syndrome rheumatism blocking collaterals syndrome differentiation standards; (4) Meet the criteria for low/medium disease activity i.e. 2.6 < DAS 28 (CRP or ESR) =5.1; (5) For those receiving prednisone (=10 mg/d) or equivalent hormone therapy the dose should be stable for at least 30 days before entering the study and the dose and usage should remain unchanged during the study period; If not used medium or short-acting hormones have not been used for at least 1 week or long-acting hormones have not been used for 2 weeks; (6) Patients who were receiving traditional synthetic anti-rheumatic drugs (csDMARDs) (such as methotrexate tablets salazopyridine leflunomide hydroxychloroquine penicillamine azathioprine cyclosporine cyclophosphamide Eramade tripterygium preparation total glucoside of Paeoniae etc.) before entering the group were treated for at least 12 weeks and the dose was kept stable; (7) 5 half-life biological agents DMARDs were discontinued before enrollment. Such as tumor necrosis factor (TNF) -a inhibitors (Etanercept infliximab Adalimumab glilizumab Becselizumab and recombinant human TNF receptor type II antibody fusion protein etc.) interleukin (IL) -1 antagonists (anabalucin) IL-6 antagonists (tolizumab) T cell inhibitors (abacipl ); Targeted synthesis of DMARDs JAK inhibitors (Tofacitib Bariatinib upatinib) etc.; (8) Be able to understand the procedures and methods of this clinical study voluntarily participate in and sign the informed consent.
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 cardiovascular brain liver lung kidney hematopoietic system endocrine system and other serious diseases patients with malignant tumors patients with mental diseases; (3) Chest CT examination indicated active lung infection interstitial lung disease suspected lung malignancy; (4) White blood cells 1.5 times the upper limit of normal; Serum creatinine (Scr) > the upper limit of normal; (5) Patients with joint function grade IV; (6) X-ray stage IV; (7) The treatment of rheumatoid arthritis with proprietary Chinese medicine Chinese medicine powder Chinese medicine decoction and other prescriptions within 2 weeks before enrollment (8) Suspected or clear history of alcohol and drug abuse; (9) people who are allergic or allergic to the components of the investigational drug (such as allergic to two or more drugs or foods); (10) Male subjects and fertile female subjects are unwilling or unable to use effective contraception during the study period; Pregnant or lactating women or those who have fertility requirements within 6 months after the last medication; (11) Participants who had participated in other drug clinical trials within 30 days before screening; (12) Other conditions that the investigator considers inappropriate to participate in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving ACR 20 after medication; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serological markers;Changes in joint swelling from baseline after medication;Changes in the investigator's overall assessment of disease activity (VAS) from baseline ;Stool routine + occult blood;Liver function;Blood pregnancy;Blood routine examination;After treatment, the proportion of patients with ACR 50 and ACR 70 was reached;Hepatitis B and hepatitis C screening;Acute phase reactants;Urine routine + sediment examination;Changes of ESR and CRP from baseline after medication;Changes of RF and ACPA from baseline after treatment;X-ray examination of both hands wrists and other affected joints;Chest CT examination;Changes of TCM syndrome score from baseline after medication;Change from baseline in subjects' overall assessment of disease activity (VAS) after medication;12-lead electrocardiogram;Changes in joint function grade from baseline after medication;Changes from baseline in the Participant Health Assessment Questionnaire Disability Index (HAQ-DI) score after medication;renal function;Proportion of patients with low/moderate disease activity who achieved disease remission after medication;Change in pain assessment (VAS) from baseline after medication;Changes in the number of joint tenderness from baseline after medication; | — |
Countries
China
Contacts
Public ContactLin Changsong
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Outcome results
None listed