Modified Chinese Medicine Granule in the Treatment of Ulcerative Colitis in the Remission Phase: Study Protocol for a Series of N-of-1 Randomized, Double-Blind, Controlled Trials

The First Affiliated Hospital of Guangzhou University 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 UC in the remission phase (determined by a UC Disease Activity Index score of 0–2 and bloody stool score of 0); the extent of UC is limited to left sided colitis and extensive colitis (Montreal classificati on E2, E3); the TCM syndrome was dampness stagnancy due to spleen deficiency syndrome;
•2. men or women aged between 18 and 75 years;
•3. participants voluntarily participated in this study, signed informed consent, and had good compliance.

•1. patients with active UC, severe UC, or acute fulminating type UC;
•2. patients undergoing treatment with corticosteroids (oral, enemas, suppository, injectable solution);
•3. patients treated with blood cell apheresis;
•4. patients who were administered anti-tumor necrosis factor-a antibody within 90 days before starting the study drug;
•5. patients with history of hypersensitivity to mesalazine and salicylic acid;
•6. patients with serious cardiovascular disease, hemodyscrasia, or lung disease or with a history of these conditions;
•7. patients with liver disease or kidney disease;
•8. patients with malignant tumor as a complication;
•9. pregnant women or those who were breastfeeding;
•10. other conditions that the researcher don't consider it was suitable.

发起方

The First Affiliated Hospital of Guangzhou University of Chinese Medicine