Rheumatoid Arthritis
Conditions
Interventions
the Controled Group:Methotrexate and decoction simulant of Huayu Tongbi Formula: oral, 150ml/pack,1 pack at a time,2 times a day
the Treated Group:Methotrexate and decoction of Huayu Tongbi Formula: oral, 150ml/pack,1 pack at a time,2 times a day
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Voluntarily sign the informed consent form before the start of activities related to this study, and understand the procedures and methods of the study, and be willing to strictly abide by the clinical study protocol to complete this study; (2) The age at the time of signing the informed consent form is 18~70 years old (including both ends), and the gender is not limited; (3) Diagnosis of RA according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 Rheumatoid Arthritis (RA) classification criteria, ACR functional classification grade I~III at screening; (4) Active disease will be assessed by Disease Activity Score (DAS) 28, with DAS28-CRP =2.6, = 5.1; (5) Have not used DMARDs in the past, if received DMARDs before,shoud stop in the past month, such as the previous use of LEF ,needs to be discontinued for 3 months, and the previous use of biological agents needs to be discontinued for 3 months; (6) If subjects are treated with nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesics for RA, they must have been on a stable dose for at least 1 week prior to enrollment.
Exclusion criteria
Exclusion criteria: (1) Within 4 weeks prior to randomization, the following conditions appeared in laboratory tests and 12-lead ECG: 1) White blood cell count 1.5 times the upper limit of normal; 6) the upper limit of normal creatinine or the estimated glomerular filtration rate (eGFR) calculated by the Diet Modification for Simplified Kidney Disease (MDRD) formula 500ms); (2) overlapping other autoimmune diseases such as primary/secondary Sjögren's syndrome, psoriatic arthritis, inflammatory bowel disease, ankylosing spondylitis, systemic lupus erythematosus, scleroderma or polymyositis, multiple sclerosis, fibromyalgia syndrome, etc.; (3) Serious diseases of important organs such as cardiovascular, brain, liver, lung, kidney, and hematopoietic system, and their therapeutic drugs affect the judgment of the efficacy of this study; (4) History of infection (viral, bacterial, fungal, parasitic infection) within 3 months before randomization, and history of infection using systemic antimicrobial therapy within 2 weeks before randomization; (5) Have severe gastrointestinal diseases (such as active or recurrent peptic ulcers), or have received treatment that may affect drug absorption (such as gastrointestinal surgery) (6) Combined with malignant tumors or previous history of malignant tumors; (7) Patients with mental illness; (8) Those who are allergic to the drug or any ingredient in the drug; (9) Those who are considered by the investigator to be inappropriate for this clinical trial; (10) Use of proprietary Chinese medicines involving RA treatment in the past 4 weeks; (11) Use of glucocorticoids orally or intra-articular injection in the past 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DAS28; | — |
Secondary
| Measure | Time frame |
|---|---|
| Metabolomics studies;Joint ultrasound;Proteomics research;SDAI;Symptom grading scale of Guiding Principles for Clinical Research of New Drugs of Traditional Chinese Medicine (Guiding Principles for Clinical Research of New Drugs of Traditional Chinese Medicine for the Treatment of Rheumatoid Arthritis);N-MID,ß-CTx,PINP;C-reactive protein;anti-cyclic citrullinated peptide antibody;rheumatoid factor;patient report outcome;CDAI;ACR20/50/70;health assessment qutionnaire;ESR; | — |
Countries
China
Contacts
Public ContactQingchun Huang
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed