One-arm, single-center clinical study for Huayu-Qiangshen-Tongbi Decoction in the treatment of preclinical rheumatoid arthritis

Guangdong Provincial Hospital of Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•(1) Patients with positive anti-CCP antibody or RF, no arthralgia or joint pain but no arthritis or synovitis, who did not meet the 2010 ACR/EULAR RA classification criteria;
•(2) No treatment with remission antirheumatic drugs (DMARDs) was received.
•(3) The age ranged from 18 to 65 years.
•(4) Written informed consent signed by the subject or his family member (guardian) to participate in the experiment.

•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.

发起方

Guangdong Provincial Hospital of Chinese Medicine