Rheumatoid arthritis
Conditions
Interventions
Test team:Kunduan Yimu Decoction and MTX
Control group:Kunduan Yimu decoction simulant and MTX
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: Those who meet all the following conditions can be included: 1. Between 18 and 70 years old (including both ends) male and female. 2. Meet the diagnostic criteria for rheumatoid arthritis in Western medicine at the time of screening (ACR/EULAR 2009 RA classification criteria and scoring system). 3. Diagnosis of moderately or severely active rheumatoid arthritis (DAS28-ESR>3.2 or DAS28-CRP>3.2) with C-reactive protein or erythrocyte sedimentation rate above the upper limit of normal at the time of screening. 4. Joint function grade I-III and radiographic stage I-III at the time of screening. 5. The patient has been treated with methotrexate (MTX) for at least 12 weeks at the time of screening and has maintained a stable dose (7.5-20mg/week) for 4 weeks. 6. Patients treated with prednisone (Dragon) (=10mg/d) or equivalent hormone therapy at screening have had a stable dose for at least 4 weeks prior to study entry and have not had their dose increased in subsequent treatments. If no hormones have been used short- and intermediate-acting hormones have not been used for at least 1 week and long-acting hormones have not been used for at least 2 weeks prior to treatment initiation. 7. If non-steroidal anti-inflammatory drugs (NSAIDs) were used in combination at the time of screening the dose had been stable for at least 4 weeks or if not used had not been used for at least 1 week.
Exclusion criteria
Exclusion criteria: One of the following will be excluded: 1. overlapping severe autoimmune diseases. 2. advanced rheumatoid arthritis deformity disability or loss of labor. 3. Hypersensitivity or allergy to the drugs used in the trial (both basic and emergency drugs). 4. Chest X-ray examination suggests active lung infection. 5. Positive test for hepatitis B surface antigen hepatitis C antibody positive HIV antibody or history of acquired immunodeficiency syndrome (AIDS). 6. Pregnant and lactating women or women of childbearing age who have had a positive pregnancy test or who have had a request for childbearing during the study period and within 6 months of the last dose. 7. Presence of any unstable cardiovascular disease (including New York Heart Association NYHA Cardiac Class IV or higher congestive heart failure unstable angina pectoris history of myocardial infarction within one year) factors that may contribute to QTc prolongation or arrhythmia such as congestive heart failure hypokalemia congenital long QT syndrome family history of long QT syndrome other coadministrations that are known to prolong the QT interval. Combination of medications known to prolong the QT interval. 8. Patients with evidence of severe progressive uncontrolled cerebrovascular disease hematopoietic endocrine (including diabetes mellitus) respiratory (including interstitial pneumonitis and pulmonary fibrosis) and other serious primary diseases and psychiatric disorders. Participation in this study would in the opinion of the investigator place the subject at unacceptable risk. 9. Persons with a history of malignant tumors. 10. Laboratory tests within 7 days prior to the start of trial dosing: (1) blood routine: blood leukocytes 1.5 × ULN; (3) Renal function: blood creatinine (Scr) > ULN; (4) Cardiac enzymes: creatine kinase lactate dehydrogenase or creatine kinase isoenzyme >1.5×ULN. 11. Received disease-modifying anti-rheumatic drugs (DMARDs) other than MTX (e.g. salicylazosulfapyridine hydroxychloroquine D-penicillamine azathioprine cyclosporine cyclophosphamide tretinoin) in the 4 weeks prior to enrollment. 12. Received elamectin treatment within 1 week prior to enrollment. 13. Have used other herbal medicines for rheumatoid arthritis within 2 weeks prior to enrollment. 14. Received leflunomide within 12 weeks prior to enrollment (if receiving standard cholestyramine-eluting therapy (cholestyramine 8g orally 3 times/day for 11 days) the drug must have been discontinued for at least 4 weeks prior to enrollment for inclusion). 15. Patients who have used biologics (including tumor necrosis factor (TNF) a-antagonists (e.g. etanercept infliximab and adalimumab) interleukin (IL)-l and IL-6 antagonists etc.) within 24 weeks prior to enrollment. 16. Patients with a history of alcohol and drug abuse. 17. Patients who in the opinion of the investigator should not participate in the trial for other reasons. 18. Participation in other clinical studies within 3 months prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in the Proportion of Subjects Meeting ACR20 at 12 Weeks of Treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in TCM single symptom efficacy after 12 weeks of treatment;Change from baseline in ESR, RF and CRP after 12 weeks of treatment and rate of change;Change from baseline in pain VAS score after 12 weeks of treatment;Changes in TCM evidence points from baseline after 12 weeks of treatment and rates of change;Improvement in joint function grading from baseline after 12 weeks of treatment;Change in time to morning stiffness from baseline after 12 weeks of treatment;Change from baseline in the proportion of subjects meeting the ACR50 after 12 weeks of treatment;Change from baseline in HAQ-DI after 12 weeks of treatment and rate of change;Total analgesic drug use (g) and proportion of use;Change from baseline in the proportion of subjects meeting ACR70 after 12 weeks of treatment;Changes in the efficacy of Chinese medicine symptoms from baseline after 12 weeks of treatment; | — |
Countries
China
Contacts
Public ContactQiang Xu
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Outcome results
None listed