Ulcerative colitis
Conditions
Interventions
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical effective rate;Clinical remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mucosal healing rate;TCM syndrome score;Quality of life score;Single symptom score;Endoscopic response rate; | — |
Countries
CHINA
Contacts
Public ContactWang Huahong
Dongfang Hospital of Beijing University of Chinese Medicine
Outcome results
None listed