A randomized controlled clinical trial of Qingdai(indigo naturalis) in the treatment of mild to moderate active ulcerative colitis
- Conditions
- ulcerative colitis
- Registration Number
- ITMCTR2000003772
- Lead Sponsor
- Shuguang Hospital affiliated to Shanghai University of traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(1) it accords with the diagnostic standard of western medicine for ulcerative colitis.
(2) the selected patients were mild to moderate ulcerative colitis (total Mayo score = 310).
(3) 18-65 years old; regardless of sex.
(4) agree to participate in this study and sign the informed letter at the same time.
(1) Patients with infectious colitis such as bacillary dysentery, amoebic dysentery, chronic schistosomiasis, intestinal tuberculosis, Crohn's disease, ischemic enteritis and radiation enteritis.
(2) Patients with serious complications such as local stenosis, intestinal obstruction, intestinal perforation, toxic colonic dilatation, massive hemorrhage, colon cancer, rectal cancer.
(3) Patients with other primary and secondary infectious diseases, such as cholecystitis, pneumonia, etc.
(4) Patients with serious diseases of cardiovascular, hepatobiliary, lung, kidney and blood system.
(5) Women during pregnancy and lactation.
(6) Patients with disabilities prescribed by law (blindness, deafness, mute, mental retardation, physical disability).
(7) Patients with severe ulcerative colitis (Mayo=11~12 score); or patients with complications.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total Mayo score;Mayo endoscopic score;
- Secondary Outcome Measures
Name Time Method TCM syndrome integral;ESR;Intestinal mucosal histopathology;Fecal calcitonin;C-reactive protein;