Clinical evaluation for traditional Chinese medicine in the treatment of severe active ulcerative colitis

Peking University First Hospital0 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) Diagnosis is in line with the active period of ulcerative colitis;
•(2) According to the improved Mayo score standard, the condition is severe (score 11-12 points);
•(3) Glucocorticoid treatmet should be effective: According to the modified Mayo score, the falling extent should be more than 30% relative to the baseline value and the score should decreased more than 3 points, and the score of bloody should reduced more than 1 point or the score is 0 or 1;
•(4) Differentiation of TCM syndrome is heat-dampness and stasis-detoxification accompanied with defeciency of spleen and kidney yang;
•(5) aged 18 to 65 years old;
•(6) Those who participate in this clinical study voluntarily, and have signed informed consent already.

•1. Patients during remission period, mild and moderate active periods;
•2. Pregnancy, lactation, or birth planning recent;
•3. Severe allergy tendency and those who allergies to the known ingredients of mesalazine or Qingchang Wenzhong Formula;
•4. Combined with severe cardiovascular and cerebrovascular diseases (chronic heart failure, cardiac function is level III or above according to New York grading standard, severe arrhythmia, severe stroke sequelae). Liver, kidney and hematopoietic system has serious primary diseases, including blood ALT, AST and Cr over the normal upper limit;
•5. Ulcerative colitis companied with serious complications, such as local stenosis, intestinal obstruction, intestinal perforation, multiple polyps in the intestine, toxic megacolon, rectal cancer, etc.
•6. Patients with mental disorders and mental disorders;
•7. Patients who have participated in other meidical clinical studies in the past 3 months;
•8. In addition to mesalazine, patients are receiving other treatments for ulcerative colitis;
•9. Seriously conditions which need to be carried on urgent treatments;
•10. Researchers believe that who is not appropriate to participate in clinical research.

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