ITMCTR2100005366Not yet recruitingPhase 1
Randomized controlled trial of powder in the treatment of rheumatoid arthritis with dampness resistance syndrome of spleen deficiency
Guangdong Provincial Hospital of Chinese Medicine0 sitesStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional study
Eligibility Criteria
- Sex
- Male
Inclusion Criteria
- •(1) Subjects should meet the following diagnostic criteria: ? Western diagnostic criteria: the 2010 ACR/EULAR RA classification criteria were used for comprehensive judgment; ? The standard of TCM syndrome diagnosis should refer to the Standard of RHEUMAToid Arthritis syndrome Diagnosis of spleen deficiency and Dampness resistance issued by China Association of Traditional Chinese Medicine in 2021 (T/CACM1347-2021);
- •(2) Patients with low disease activity according to DAS28-CRP score (2.6=DAS28-CRP=3.2);
- •(3) Aged between 18 and 70;
- •(4) Have not been treated with palliative antirheumatic drugs (DMARDs), or have been treated with DMARD drugs in the past, but have not used such drugs for at least one month;
- •(5) Written informed consent signed by the subject or his/her family (guardian) agreeing to participate in the study.
Exclusion Criteria
- •(1) history of other autoimmune diseases, such as sjogren's syndrome, systemic lupus erythematosus, etc.; Having an acute or chronic infectious disease, including hepatitis B or C infection; A previous history of cancer; Evidence of active, latent or inadequately treated Mycobacterium tuberculosis infection;
- •(2) patients with serious cardiovascular, brain, lung, liver, kidney and hematopoietic diseases;
- •(3) pregnant or lactating women or patients with known mental disorders;
- •(4) Patients with hemoglobin level less than 90 g/L, white blood cell count less than 3.0×109 /L, or platelet count less than 100×109 /L;
- •(5) patients with glomerular filtration rate below 40ml/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 the test drug;
- •(9) Screening of patients participating in other clinical trials within 4 weeks.
Investigators
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