Randomized controlled trial of powder in the treatment of rheumatoid arthritis with dampness resistance syndrome of spleen deficiency

Phase 1

Not yet recruiting

• Conditions: Rheumatoid Arthritis

• Registration Number: ITMCTR2100005366
• Lead Sponsor: Guangdong Provincial Hospital of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DAS28-CRP;

Secondary Outcome Measures

Name	Time	Method
quality of life score;medication safety;RF;ESR;Joint symptoms and signs;CCP;ACR20;9/5000 X-ray examination of the involved joint;CRP;