A randomized, double-blind, prospective, controlled trial for Yishen-Tongbi-Tang in the treatment of active rheumatoid arthritis

Not Applicable

• Conditions: Rheumatoid Arthritis

• Registration Number: ITMCTR1900002503
• Lead Sponsor: The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

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

Inclusion Criteria

1. Meet the 2010 European League Against Rheumatism and the American College of Rheumatology RA classification criteria and have a RA course of at least 6 weeks;
2. Aged 18-65 years old;
3. AT least three swollen joints (SJC) and five tender joints (TJC);
4. Erythrocyte sedimentation rate (ESR)>28mm/h or C-reactive protein (CRP)>20mg/L;
5. Sign the informed consent form.

Exclusion Criteria

1. pregnant or lactating women;
2. There are fertility requirements at present and in the future;
3. History of chronic severe infection, any current infection and any malignant tumor;
4. Patients with severe primary diseases and mental illnesses such as cardiovascular, cerebrovascular, hepatic, renal and hematopoietic systems;
5. Those with a history of drug allergy;
6. Using disease-modifying anti-rheumatic drugs (DMARDs) and biological disease-modifying anti-rheumatic drugs within the first 3 months of enrollment;
7. The investigator believes that it is not appropriate to participate in this clinical trial.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
SDAI;CDAI;

Secondary Outcome Measures

Name	Time	Method
DAS28;ACR20;ACR70;ACR50;