Exploratory study for the treatment of rheumatoid arthritis by eliminating dampness
- Conditions
- Rheumatoid Arthritis
- Registration Number
- ITMCTR2000003354
- Lead Sponsor
- Guangdong Provincial Hospital of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(1) Research subjects should meet the following diagnostic criteria: ? Western medicine diagnostic criteria: comprehensive judgment using the 2010 ACR / EULAR RA classification standard; ? TCM syndrome types meet the diagnostic criteria of wet syndrome recognized by experts
(2) According to the DAS28-CRP score, patients whose disease is in a low activity period (2.6 (3) The age is 18 ~ 70 years old;
(4) Have not been treated with disease-modifying antirheumatic drugs (DMARDs), or have previously received DMARDs, but have not used such drugs for at least one month;
(5) A written informed consent form signed by a family member (guardian) with hypertension who agreed to participate in this trial.
Patients who meet or expect to meet any of the following criteria will not be allowed to participate in this study:
(1) history of other autoimmune diseases, such as Sjogren's syndrome and systemic lupus erythematosus; acute or chronic infectious diseases, including hepatitis B or hepatitis C infection; past history of cancer; evidence of active, latent or improperly treated Mycobacterium tuberculosis infection;
(2) Patients with severe cardiovascular, brain, lung, liver, kidney and hematopoietic diseases;
(3) Pregnant women, lactating women or patients with known mental disorders;
(4) Patients with hemoglobin level less than 90 g/L, white blood cell count less than 3.0 *10^9/L, or platelet count less than 100 *10^9/L;
(5) Patients whose glomerular filtration rate is lower than 40 ml/min;
(6) The level of aspartate aminotransferase or alanine aminotransferase was 1.5 times higher than the upper limit of normal range.
(7) Patients with active gastroduodenal ulcer or gastritis caused by long-term use of NSAIDs;
(8) Patients allergic to experimental drugs;
(9) Screening patients who participated in other clinical trials within 4 weeks.
(10) Patients with damp-heat syndrome.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CCP;DAS28;ACR20 remission rate;RF;
- Secondary Outcome Measures
Name Time Method ESR;medication safety;CRP;General symptoms and signs;Joint symptoms and signs;MRI evaluation of the involved joint;