Rheumatoid arthritis
Conditions
Interventions
experimental group:The patients received Huayu Qiangshen Tongbi optimization C decoction granules (3 bags each time 2 times a day oral) and Shenlingbaizhu powder capsules (3 capsules each time 3 times
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Patients with disease at low to moderate disease activity by DAS28-CRP score (2.6 < DAS28-CRP = 5.1); 2) Age between 18 and 70 years old; 3) Meet the indications for the biologic agent adalimumab; 4) If subjects are taking oral MTX their dose must be stabilized at a dose of 12.5 mg qw for at least 4 weeks prior to enrollment; if subjects are taking oral glucocorticosteroids their dose must be stabilized at a dose equivalent to =10 mg/day of prednisone for at least 4 weeks prior to enrollment; if discontinued oral glucocorticosteroids should be discontinued at least 2 weeks prior to enrollment; 5) Those who sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating women or those who plan to become pregnant during the study cycle; 2) Combined history of systemic immune diseases other than dry syndrome such as systemic lupus erythematosus and vasculitis; 3) Patients with combined serious primary diseases of the respiratory system circulatory system etc. which cannot be controlled by conventional medication; patients with combined history of serious infections infectious diseases such as tuberculosis and hepatitis lymphocyte hyperplasia hematopoietic abnormalities and neoplasms; patients with combined serious disorders of water electrolyte and acid-base balance; patients with combined primary or secondary immune deficiencies and hypersensitivity; and patients with combined serious psychiatric disorders. Patients with the following clinical indicators: Increase in alanine aminotransferase or glutamine aminotransferase > 3 times the upper limit of normal value; Increase in creatinine > 1.5 times the upper limit of normal value; Positive HIV serology; Any one of the major indicators of routine blood tests is below the lower limit of normal value; or other laboratory tests are abnormal in the investigator's judgment not suitable for participation in the trial; 4) Patients with known allergy to the drugs used in this study and to the components containing the drugs in question; 5) Patients who are participating in clinical trials of other drugs or who have participated in other clinical trials within 4 weeks; (vi) Those who are treated with herbal or proprietary Chinese medicines topical therapies (topical hormonal agents etc.) within 2 weeks; those who are treated with oral analogs of systemic therapies other than methotrexate and leflunomide (salazosulfapyridine azathioprine hydroxychloroquine exemplar cyclosporine merti-mecrolide tacrolimus etc.) within 4 weeks; and those who are treated with leflunomide within 12 weeks (except that if standard anticholinergic washout therapy is received for 11 days leflunomide will be required at the start of study treatment). mide will need to be discontinued at least 4 weeks prior to initiation of study treatment); those treated within 5 biologic half-lives (e.g. etanercept 17.5 days infliximab 50 days adalimumab 70 days etc.); 7) Those who have received interferon therapy within 4 weeks prior to enrollment or who are expected to require interferon therapy during the study period; those who have been immunized with a live vaccine within 2 weeks prior to enrollment or who will require immunization with a live vaccine during the trial period; 8) Patients with active gastroduodenal ulcers or gastritis due to long-term use of NSAIDs; 9) Patients deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| RF;Anti-ccp TEST;Health Assessment Questionnaire HAQ;X-ray examination of the affected joint;DAS28-CRP;ESR;CRP;Incidence of adverse reactions;Ultrasound examination of the affected joints was performed;DFR;The interval between the first recurrence; | — |
Countries
China
Contacts
Public ContactHuang Runyue
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed