Clinical evaluation of traditional Chinese medicine on moderate active ulcerative colitis: a multi-center, randomized, double-blind, controlled trial

Phase 1

Recruiting

• Conditions: lcerative colitis

• Registration Number: ITMCTR1900002336
• Lead Sponsor: Dongfang Hospital of Beijing University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical effective rate;Clinical remission rate;

Secondary Outcome Measures

Name	Time	Method
Mucosal healing rate;TCM syndrome score;Single symptom score;Quality of life score;Endoscopic response rate;