Ulcerative colitis
Conditions
Interventions
TCM Group:Qingchang Wenzhong Granules+Mesalazine Enteric-coated Tablets(Salofalk)Simulator
020301
Sponsors
Dongfang Hospital of Beijing University of Chinese Medicine
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 moderate (score 6-10 points); 3. Differentiation of TCM syndrome is heat-dampness and stasis blocked accompanied with defeciency of spleen yang; 4. 18 to 65 years old; 5. 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 severe 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical effective rate;Clinical remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mucosal healing rate;TCM syndrome score;Single symptom score;Quality of life score;Endoscopic response rate; | — |
Countries
China
Contacts
Public ContactLi Junxiang
Gastroenterology Department, Dongfang Hospital, Beijing University of Chinese Medicine
Outcome results
None listed