World Health Organization site
Skip Navigation Links

Please fill this short user satisfaction survey


Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ITMCTR
Last refreshed on: 20 February 2023
Main ID:  ITMCTR2000003530
Date of registration: 2020-07-31
Prospective Registration: Yes
Primary sponsor: Jiangsu Province Hospital of Chinese Medicine
Public title: Study on TCM accurate syndrome differentiation and treatment scheme of ulcerative colitis based on intestinal microecology and multi-omics technology
Scientific title: Study on TCM accurate syndrome differentiation and treatment scheme of ulcerative colitis based on intestinal microecology and multi-omics technology
Date of first enrolment: 2020-08-01
Target sample size: qi deficiency syndrome control group:30;damp-heat syndrome control group:30;healthy control group:30;qi deficiency syndrome treatment group:60;ulcerative colitis damp-heat syndrome group:30;damp-heat syndrome treatment group:60;ulcerative colitis qi defi
Recruitment status: Recruiting
URL:  http://itmctr.ccebtcm.org.cn/en-US/Home/ProjectView?pid=af97d0c9-c2f4-4771-8305-60c7f7361504
Study type:  Interventional study
Study design:  Parallel  
Phase:  0
Countries of recruitment
China
Contacts
Name: Lu Zhang   
Address:  155 Hanzhong Road, Nanjing, Jiangsu, China
Telephone: +86 15380833946
Email: zhanglu0321@126.com
Affiliation:  Jiangsu Province Hospital of Chinese Medicine
Name: Hong Shen   
Address:  155 Hanzhong Road, Nanjing, Jiangsu, China
Telephone: +86 13851872859
Email: shenhong999@163.com
Affiliation:  Jiangsu Province Hospital of Chinese Medicine
Key inclusion & exclusion criteria
Inclusion criteria: Research content 1
1. Inclusion criteria for subjects with ulcerative colitis were as follows:
(1) It was in accordance with the diagnostic standard of Western medicine for ulcerative colitis;
(2) TCM syndrome differentiation belongs to damp heat syndrome or qi deficiency syndrome;
(3) The age ranged from 18 to 65 years old;
(4) Patients who are informed and sign informed consent.
2. The inclusion criteria of healthy subjects were as follows:
(1) Healthy volunteers who had physical examination in our hospital;
(2) The age ranged from 18 to 65 years old;
(3) Patients who are informed and sign informed consent.
Research content 2
(1) It was in accordance with the diagnostic standard of Western medicine for ulcerative colitis;
(2) TCM syndrome differentiation belongs to damp heat syndrome or qi deficiency syndrome;
(3) The age ranged from 18 to 65 years old;
(4) Patients who are informed and sign informed consent.

Exclusion criteria: Research content 1
1. Exclusion criteria for subjects with ulcerative colitis:
(1) Patients with infectious colitis such as bacillary dysentery, amebic dysentery, chronic schistosomiasis, intestinal tuberculosis, Crohn's disease, ischemic enteritis and radiation enteritis;
(2) Patients with severe complications such as local stenosis, intestinal obstruction, intestinal perforation, toxic megacolon, massive hemorrhage, colon cancer and rectal cancer;
(3) Patients with other primary and secondary infectious diseases, such as cholecystitis, pneumonia, etc;
(4) Patients with serious cardiovascular, hepatobiliary, pulmonary, renal and hematological diseases;
(5) Pregnant and lactating women;
(6) People with disabilities prescribed by law (blindness, deafness, muteness, mental retardation, physical disability).
2. The exclusion criteria of healthy subjects were as follows:
(1) Patients with other primary and secondary infectious diseases, such as cholecystitis, pneumonia, etc;
(2) Patients with serious cardiovascular, hepatobiliary, pulmonary, renal and hematological diseases;
(3) Pregnant and lactating women;
(4) People with disabilities prescribed by law (blindness, deafness, muteness, mental retardation, physical disability).

Research content 2
(1) Patients with infectious colitis such as bacillary dysentery, amebic dysentery, chronic schistosomiasis, intestinal tuberculosis, Crohn's disease, ischemic enteritis and radiation enteritis;
(2) Patients with severe complications such as local stenosis, intestinal obstruction, intestinal perforation, toxic megacolon, massive hemorrhage, colon cancer and rectal cancer;
(3) Patients with other primary and secondary infectious diseases, such as cholecystitis, pneumonia, etc;
(4) Patients with serious cardiovascular, hepatobiliary, pulmonary, renal and hematological diseases;
(5) Pregnant and lactating women;
(6) People with disabilities prescribed by law (blindness, deafness, muteness, mental retardation, physical disability). (7) Suspected or confirmed history of alcohol and drug abuse.
(8) According to the researcher's judgment, other situations that reduce the possibility of enrollment or complicate the enrollment, such as frequent changes in the working environment, are likely to cause loss of follow-up.
(9) Allergic constitution, such as allergic history to two or more drugs or food; or known to be allergic to the ingredients of the drug.
(10) Patients who are participating in other clinical studies.


Age minimum: 18
Age maximum: 65
Gender: Both
Health Condition(s) or Problem(s) studied
Uicerative colitis
Intervention(s)
qi deficiency syndrome control group:Mesalazine;damp-heat syndrome control group:Mesalazine;healthy control group:nil;qi deficiency syndrome treatment group:Modified Shenling Baizhu Powder and Mesalazine;ulcerative colitis damp-heat syndrome group:nil;damp-heat syndrome treatment group:Modified Gegenqinlian Decoction and Mesalazine;ulcerative colitis qi deficiency syndrome group:nil;
Primary Outcome(s)
clinical efficacy rate;
Secondary Outcome(s)
laboratory index;mucosal healing rate;TCM syndrome efficacy;indicators of intestinal flora, metagenome and metabolome;endoscopic response rate;clinical remission rate;quality of life;
Secondary ID(s)
ChiCTR2000035099
ChiMCTR2000003530
Source(s) of Monetary Support
Science and Technology Department of Jiangsu Province; Jiangsu Province Hospital of Chinese Medicine
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 03/03/2020
Contact:
Xi Zou
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history Please fill this short user satisfaction survey