Clinical evaluation for traditional Chinese medicine in the treatment of severe active ulcerative colitis

• Register: ChiCTR
• Last refreshed on: 22 July 2019
• Main ID: ChiCTR1900024591
• Date of registration: 2019-07-18
• Prospective Registration: Yes
• Primary sponsor: Peking University First Hospital
• Public title: Clinical evaluation for traditional Chinese medicine in the treatment of severe active ulcerative colitis
• Scientific title: Clinical evaluation for traditional Chinese medicine in the treatment of severe active ulcerative colitis
• Date of first enrolment: 2019-07-22
• Target sample size: TCM Group:40;Convenience medicine Group:40;Combined Group:40;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=41168
• Study type: Interventional study
• Study design: Parallel
• Phase: 0

Countries of recruitment

China

Contacts

• Name: Shi Lei
• Affiliation: Dongfang Hospital of Beijing University of Chinese Medicine

• Name: Wang Huahong
• Affiliation: Dongfang Hospital of Beijing University of Chinese Medicine

Key inclusion & exclusion 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: 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.

Age minimum: 18
Age maximum: 65
Gender: Both

Health Condition(s) or Problem(s) studied

Ulcerative colitis

Intervention(s)

TCM Group:Prednisone+New Wumeiwan Formula;Convenience medicine Group:Prednisone+Mesalazine Enteric-coated tablets (Salofalk);Combined Group:Prednisone+New Wumeiwan Formula+Mesalazine Enteric-coated tablets(Salofalk);

Primary Outcome(s)

Clinical effective rate;Clinical remission rate;

Secondary Outcome(s)

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

Source(s) of Monetary Support

National Key R&D Program of China (2018YFC1705400)

Ethics review

Status: Approved
Approval date: 26/06/2019
Contact:

Liang Yan