Clinical study for the prevention and treatment of rheumatoid arthritis by Hua-Yu Qiang-Shen Tong-Bi Decoctio

Phase 1

• Conditions: Rheumatoid Arthritis

• Registration Number: ITMCTR1900002806
• Lead Sponsor: Guangdong Provincial Hospital of 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. diagnostic criteria:
(1) meet the ACR/EULAR 2010 revised criteria for RA;
(2) diagnostic criteria of TCM syndrome: the TCM syndrome diagnosis criteria refers to the Diagnostic Basis and Syndrome Classification of the Guidelines for the Combination of Diagnosis and Treatment of Rheumatoid Arthritis issued by the China Association of Chinese Medicine in 2019. The syndrome differentiation of TCM is cold-damp syndrome and/or wind-damp syndrome.
2. disease activity assessed by DAS28-CRP score. Patients with low disease activity (3.2 >DAS28-CRP>2.6) will be recruited;
3. between 18 to 65 years of age;
4. have not been treated with DMARDs or have been treated with DMARD but not take DMARDs for at least 1 week prior to screening;
5. agree to participate in the study and sign an informed consent form.

Exclusion Criteria

1. have a history of another autoimmune rheumatic disease such as Sjogrens syndrome or Systemic lupus erythematosus; with acute or chronic infection, including hepatitis B or hepatitis C infection; evidence of active, latent, or inadequately treated Mycobacterium tuberculosis infection; have a history of cancer;
2. patients with severe cardiovascular, brain, lung, liver, kidney, or hematopoietic diseases;
3. pregnant women or breastfeeding mothers or those with known psychiatric disorders;
4. a hemoglobin level of less than 90g/L, a white cell count of less than 3.0x10^9/L, or a platelet count of less than 100x10^9/L;
5. an estimated glomerular filtration rate of 40 ml per minute or less;
6. the aspartate aminotransferase or alanine aminotransferase level higher than 1.5 times the upper limit of the normal range;
7. patients with an active gastroduodenal ulcer or gastritis caused by the long-term use of NSAIDs;
8. patients that are found to be hypersensitive to the trial medication;
9. patients that have participated in other clinical trials within 4 weeks of screening.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
DAS28;rheumatoid factor;ESR;the Magnatic Resonance Imaging of joint;anti-cyclic citrullinated peptide antibody;ACR20;CRP;