ITMCTR2100004334招募中1 期
Clinical Study on the Treatment of Ankylosing Spondylitis with Integrated Traditional Chinese and Western Medicine
Guangdong Provincial Hospital of Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 70（—）
- 性别
- All
入选标准
- •(1) The study subjects should meet the following diagnostic criteria: ? Western medical diagnostic criteria: New York criteria revised by the American College of Rheumatology in 1984;(2) TCM syndrome diagnosis criteria: according to Professor Jiao Shude's Big Stoop (Ankylosing Spondylitis) Etiology, Pathogenesis and Syndrome Differentiation Discussion revised.
- •(2) Active patients with ankylosing spondylitis (Basdai >4);
- •(3) Aged 18-70 years(inclusive)
- •(4) The use of NSAIDs has been stopped for 2 weeks;
- •(5) The use of remission anti-rheumatic drugs (DMARDs) has been stopped for 1 month;
- •(6) The use of biological agents has been stopped for 3 months;
- •(7) Signed the informed consent.
排除标准
- •Potential subjects meeting the inclusion criteria will be excluded if they meet any of the following criteria:
- •(1) Peripheral articular AS (classification standard of AS according to 2009ACR);
- •(2) Patients with advanced disease, complete spine rigidity and severe joint deformity indicated by clinical or imaging;
- •(3) The baseline examination showed abnormal platelet, white blood cell and hemoglobin in the following laboratory indicators, which had clinical significance;Serum creatinine, AST, ALT, ALP, GGT, TBIL were 1.25 times higher than normal.The urine routine was abnormal, and the erythrocyte > / HP and occult blood were positive in stool routine, which had clinical significance.
- •(4) Pregnant women, lactating women, or women who intend to become pregnant within one year;
- •(5) Participating in other clinical trials;
- •(6) Those who have received treatment under this plan but have no effect;
- •(7) Patients with severe primary heart, liver, kidney and other organ function impairment or other possible interference with follow-up evaluation;
- •(8) The researchers believe that they cannot enter the clinical researchers.
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