Efficacy of Herbal enema prescriptionII(DHEP II) in the treatment of mild or moderate active symptoms of ulcerative colitis:A multicenter prospective randomized control clinical trial.
- Conditions
- lcerative colitis
- Registration Number
- ITMCTR1900002594
- Lead Sponsor
- anjing Hospital of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) Patients meeting the Western diagnostic criteria for ulcerative colitis(See the research proposal for details);
(2) Comply with the diagnostic criteria for TCM syndromes of ulcerative colitis(See the research proposal for details);
(3) The condition is mild to moderate active patients aged 18-75 years;
(4) No history of diarrheal disease or other gastrointestinal diseases in the past 4 weeks;
(5) Antibiotics and microecological preparations were not taken within the past 1 month;
(6) Signed into the study informed consent form.
(1) There are serious complications, such as local stenosis, intestinal obstruction, intestinal perforation, rectal insufficiency, toxic colon expansion, colon cancer, rectal cancer and anal diseases;
(2) Women who are pregnant or are preparing for pregnancy, lactating women;
(3) Allergies and those who are allergic to multiple drugs;
(4) Patients with serious diseases such as liver, kidney, hematopoietic system and endocrine system and mental patients;
(5) The condition is critical and it is difficult to make a definitive evaluation of the effectiveness and safety of the new drug.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method relapse Intervals;
- Secondary Outcome Measures
Name Time Method albumin;Evaluation criteria for mucosal lesions;Truelove-Witts;ESR;Mayo index;Comprehensive efficacy criteria;Calprotectin;IL6;HB;Safety evaluation standard;TNF-a;Intestinal flora;TCM symptom evaluation criteria;CRP;