Rheumatoid arthritis
Conditions
Interventions
Test group:4 tablets each time, 3 times a day
control group:4 tablets each time, 3 times a day
Sponsors
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Male or female, aged 18~70 (both ends inclusive). 2.Diagnosed with Rheumatoid Arthritis.(1987 American College of Rheumatology classification criteria for Rheumatoid Arthritis). 3.Exhibiting Wind-cold-dampness symptoms. 4. Diagnosed with moderately or severely active Rheumatoid Arthritis (DAS28-ESR>3.2 or DAS28-CRP>3.2), while the C-reactive protein or erythrocyte sedimentation rate exceed the the upper limit of normal range.? 5. The function of joint is graded I ~ III, and the X-ray shows in grade I ~ III. 6. Treated with Methotrexate (MTX) for at least 12 weeks , and the dose stable (7.5 ~ 20mg / week) for 4 weeks before the trial. 7. Prednisone (Dragon) (=10mg / D) or equivalent dose of hormone is taken steady for at least 4 weeks before the trial, and the dosage will not increase in subsequent treatment. If hormone is not used, short acting and medium acting hormones have not been used for at least 1 weekor long-acting hormones have not been used for at least 2 weeks before the trial. 8. If Non-steroidal anti-inflammatory drugs (NSAIDs) are used in combination, the dose had been stable for at least 4 weeks. Or, NSAIDs had not been taken for at least 1 week. 9. Voluntarily sign informed consent form.
Exclusion criteria
Exclusion criteria: 1. Overlapping severe autoimmune diseases. 2. People with advanced deformity, disability and loss of labor force of Rheumatoid Arthritis. 3. Known allergic reactions to components of the study agent , including basis medicine or first-aid medicine; Allergic constitution. 4. X-ray indicates actively pulmonary infection. 5. Carried with HbsAg, anti-HCV, HIV antibody or AIDS. 6. Pregnancy or lactation , or those have fertility plans less than 6 months after the last administration. 7. Presence of unstable cardiovascular diseases, including NYHA cardiac function grade III or IV, Congestive heart failure, Unstable angina pectoris, history of myocardial infarction within one year; lived with the factors that can lead to QTc prolongation or arrhythmia, such as Congestive heart failure, Hypokalemia, Congenital long QT syndrome, family history of long QT syndrome, or other known combined drugs that can prolong QT interval. 8. Carried with severely, progressively and uncontrolled cerebrovascular diseases, Hematopoiesis problem, Endocrine ?disease (Diabetes), Respiratory disease (Interstitial pneumonia and Pulmonary fibrosis) and other serious primary diseases or mental diseases. The investigator considers that background?disease will put human subjects at unacceptable risk. 9. Have a history of malignant tumor. 10. The result of laboratory examination within 7 days before taking the trial medication: (1) Blood routine examination: white blood cells 1.5 × ULN (3) Renal function: serum creatinine (SCR) > ULN; (4) Myocardial enzyme: creatine kinase, lactate dehydrogenase or creatine kinase isoenzyme > 1.5 × ULN 11. Treatment with disease-modifying anti-rheumatic drugs(DMARDs) within 2 weeks before the trial, such as Sulfasalazine, Hydroxychloroquine, D-penicillamine, Azathioprine, Cyclosporin, Cyclophosphamide and Tripterygium wilfordii preparation, excluded MTX. 12. Treatment with Ella moder within 1 week before the trial. 13. Received the traditional Chinese medicines or therapy for Rheumatoid Arthritis within 2 weeks before the trial. 14. Treatment with Leflunomide within 12 weeks; Under condition of the patient can be recruited that withdrawing medications for at least 4 weeks before the trial, and meanwhile receive Standard cholestyramine elution therapy (cholestyramine 8g orally, 3 times / day, for 11 consecutive days). 15. Treatment with biological agents within 24 weeks before participating the trial : tumor necrosis factor (TNF), Adrenergic alpha-antagonists(Etanercept, Infliximab, Adalimumab), Interleukin (IL) - L and IL-6 antagonists, etc. 16. Abuser of alcohol and drug. 17. The investigator suggests that other reasons are not suitable for participating in this trial. 18. Participate in other clinical researcher within 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects meeting ACR20; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change value and rate of TCM syndrome score compared with baseline;;The change value and rate of pain VAS score compared with baseline;;Change value and change rate of HAQ-DI compared with baseline;;The change value and rate of morning stiffness time compared with baseline;;Proportion of subjects meeting acr50 and acr70;;Proportion and total amount of analgesic drugs (g);TCM syndrome curative effect;;The improvement rate of joint function grade compared with baseline;;Curative effect of single symptom of traditional Chinese Medicine;Change value and change rate of ESR, RF and CRP compared with baseline;; | — |
Countries
China
Contacts
Public ContactWei Liu
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed