Ulcerative colitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years 2. Clinical diagnosis of ulcerative colitis 3. TCM syndrome conforming to spleen-kidney yang deficiency type 4.Signed informed consent, good compliance with researchers' observations and treatments, voluntary participation.
Exclusion criteria
Exclusion criteria: 1)Intestinal inflammatory diseases caused by other reasons: infectious colitis (bacillary dysentery, amoebic dysentery, chronic schistosomiasis, intestinal tuberculosis, etc.), Crohn's disease, ischemic colitis, radiation colitis, high-grade intraepithelial neoplasia rectal lesions, or patients with positive fecal viral/bacterial tests (Shigella, Salmonella, Campylobacter, Yersinia, E. coli, etc.); 2) Severe underlying diseases (cardiovascular, hepatic, renal, pulmonary, etc.) or other serious complications; 3) Severe gastrointestinal diseases: toxic megacolon, gastrointestinal tumors, perforation, massive bleeding, intestinal obstruction, etc.; 4) Severe mental disorders or communication barriers preventing cooperation; 5) Pregnant/lactating women, those planning pregnancy, or patients allergic to study medications; 6) Patients using medications incompatible with Asacol (thioguanine, mercaptopurine, ampicillin, probenecid, warfarin, methotrexate, folic acid, etc.) within 1 week, or those receiving varicella vaccine/steroid medications (prednisone, etc.); 7) Participation in other clinical trials within 1 month; 8) Biologic agent use within 1 month; 9) Severe allergy or hypersensitivity to Asacol/TCM components.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improved Mayo score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Baron endoscopic score;Effectiveness of Traditional Chinese Medicine Syndromes;IBDQ inflammatory bowel disease quality of life score;UC-SQ ulcerative colitis symptom score;Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score;Geboes score;Modified Truelove and Witts Disease Severity Classification;fecal calprotectin;cytokine;Erythrocyte Sedimentation Rate;C-reactive protein;Vitamin D;Coagulation Function; | — |
Countries
China
Contacts
Shuguang Hospital affiliated to Shanghai University of TCM