Prospective cohort study of Qing Chang Wen Zhong decoction in the treatment of patients with mild and moderate ulcerative colitis.

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-OCH-14004615
• Date of registration: 2014-05-07
• Prospective Registration: Yes
• Primary sponsor: Dongfang Hospital Affiliated to Beijing University of Traditional Chinese Medicine
• Public title: Prospective cohort study of Qing Chang Wen Zhong decoction in the treatment of patients with mild and moderate ulcerative colitis.
• Scientific title: Prospective cohort study of qingchangwenzhong decoction in the treatment of patients with mild and moderate ulcerative colitis.
• Date of first enrolment: 2014-05-12
• Target sample size: clinical group:60;control:60;
• Recruitment status: Completed
• URL: http://www.chictr.org.cn/showproj.aspx?proj=4958
• Study type: Observational study
• Study design: Cohort study
• Phase: Other

Countries of recruitment

China

Contacts

• Name: Xiaowei Chen
• Affiliation: Department of Digestion internal, Dong Fang Hospital Affiliated to Beijing University of Traditional Chinese Medicine

• Name: Xiaowei Chen
• Affiliation: Department of Digestion internal, Dong Fang Hospital Affiliated to Beijing University of Traditional Chinese Medicine

Key inclusion & exclusion criteria

Inclusion criteria: 1. In accordance with the diagnosis criteria of ulcerative colitis in Western medicine and
(1) severity mild or moderate;
(2) active stage.
2. TCM syndrome differentiation: intermingled heat and cold,and stagnant dampness-heat;
3. Aged between 18 and 65 years old, male and female;
4. Voluntary and signed informed consent;
5. Willing to participant.
Exclusion criteria: (1)Patients with severe complications: local stenosis, intestinal obstruction, intestinal perforation, toxic dilation of the colon, colon cancer, rectal cancer and diseases of anus; (2)Pregnancy or are preparing to pregnant women, breast-feeding women; (3)Patients of allergic constitution and multi-drug allergies; (4)Combined liver, kidney, hematopoietic system, endocrine system and other serious diseases and mental illness,or combined serious mental illness; (5) Patients with other treatment options for ulcerative colitis, besides the treatment options of the study.

Age minimum: 18
Age maximum: 65
Gender: Both

Health Condition(s) or Problem(s) studied

ulcerative colitis

Intervention(s)

clinical group:Qing Chang Wen Zhong decoction;control:Mesalazine Enteric-coated Tablets or Medichemie Ettingen;

Primary Outcome(s)

Improvement of colonic mucosa lesions;disease activity index;Truelove index;IBQD;

Source(s) of Monetary Support

The 2014 independent subject of Beijing University of Chinese Medicine