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

• Register: ChiCTR
• Last refreshed on: 20 May 2019
• Main ID: ChiCTR1900023159
• Date of registration: 2019-05-14
• Prospective Registration: Yes
• Primary sponsor: Dongfang Hospital of Beijing University of Chinese Medicine
• Public title: Clinical evaluation of traditional Chinese medicine on moderate active ulcerative colitis: a multi-center, randomized, double-blind, controlled trial
• Scientific title: Clinical evaluation of traditional Chinese medicine on moderate active ulcerative colitis: a multi-center, randomized, double-blind, controlled trial
• Date of first enrolment: 2019-05-20
• Target sample size: ?????????+???????(???)???:90;Medical Group:90;Combined Group:90;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=38963
• Study type: Interventional study
• Study design: Parallel
• Phase: 0

Countries of recruitment

China

Contacts

• Name: Li Junxiang
• Affiliation: Gastroenterology Department, Dongfang Hospital, Beijing University of Chinese Medicine

• Name: Shi Lei
• 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 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.

Age minimum: 18
Age maximum: 65
Gender: Both

Health Condition(s) or Problem(s) studied

Ulcerative colitis

Intervention(s)

?????????+???????(???)???:Qingchang Wenzhong Granules+Mesalazine Enteric-coated Tablets(Salofalk)Simulator;Medical Group:Mesalazine Enteric-coated Tablets(Salofalk)+Qingchang Wenzhong Granules Simulator;Combined Group:Qingchang Wenzhong Granules+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: 22/04/2019
Contact:

Xia Yun