Clinical Observation on Treating Moderate and Severe Ulcerative Colitis with Bupiwei Xieyinhuo Shengyang supplemented decoctio
- Conditions
- lcerative Colitis
- Registration Number
- ITMCTR2100005224
- Lead Sponsor
- Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) 18 years of age to 65 years of age, regardless of gender;
(2) In line with the modern medical diagnosis of ulcerative colitis, patients with moderate to severe active ulcerative colitis. The modified Mayo score is 6-12 points.
(3) Chronic recurrence type or persistent type, with a medical history of more than 6 months.
(4) Those who voluntarily participate in this clinical trial, have informed consent and signed an informed consent form.
(1) Pregnant or lactating women, patients with recent birth plans;
(2) Confirmed or suspected bacterial dysentery, amoebic dysentery, intestinal schistosomiasis, intestinal tuberculosis, fungal colitis, antibiotic-related colitis, eosinophilic colitis, Behcet's disease, Crohn Diseases, ischemic enteritis, radiation enteritis, indeterminate colitis, colonic diverticulitis, colorectal cancer;
(3) The subject has diseases such as the heart, lung, liver, kidney, cardiovascular, endocrine system, immune system, hematopoietic system, and nervous system, and the researcher believes that it will interfere with the research results or endanger the safety of the subject;
(4) Gastrointestinal diseases and surgery that affect drug absorption, and colon surgery is expected to be performed within 12 weeks after enrollment;
(5) Those who suspect or do have a history of alcohol or drug abuse;
(6) Participated in other drug clinical trials within the past one month;
(7) Those who are in critical condition and are difficult to make an accurate assessment of the effectiveness and safety of the drug;
(8) ALT, AST=1.5 times the upper limit of normal, Scr>1.5 times the upper limit of normal;
(9) Complications, such as intestinal obstruction, intestinal perforation, toxic colon dilation, and lower gastrointestinal bleeding;
(10) Those who have contraindications to colonoscopy;
(11) According to the researcher's judgment, those who are likely to be lost to follow-up or other reasons that are not suitable for selection.
Study & Design
- Study Type
- Observational study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Modified Mayo Score;
- Secondary Outcome Measures
Name Time Method TCM syndrome score;IBDQ Inflammatory Bowel Disease Quality of Life Questionnaire;Geboes Index;BARON score;Individual symptom score;