Main
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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:
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ITMCTR |
Last refreshed on:
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20 February 2023 |
Main ID: |
ITMCTR2000003530 |
Date of registration:
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2020-07-31 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study on TCM accurate syndrome differentiation and treatment scheme of ulcerative colitis based on intestinal microecology and multi-omics technology
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Scientific title:
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Study on TCM accurate syndrome differentiation and treatment scheme of ulcerative colitis based on intestinal microecology and multi-omics technology |
Date of first enrolment:
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2020-08-01 |
Target sample size:
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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:
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http://itmctr.ccebtcm.org.cn/en-US/Home/ProjectView?pid=af97d0c9-c2f4-4771-8305-60c7f7361504 |
Study type:
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Interventional study |
Study design:
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Parallel
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Phase:
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0
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Countries of recruitment
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China
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Contacts
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Name:
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Lu Zhang
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Address:
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155 Hanzhong Road, Nanjing, Jiangsu, China
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Telephone:
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+86 15380833946 |
Email:
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zhanglu0321@126.com |
Affiliation:
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Jiangsu Province Hospital of Chinese Medicine |
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Name:
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Hong Shen
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Address:
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155 Hanzhong Road, Nanjing, Jiangsu, China
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Telephone:
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+86 13851872859 |
Email:
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shenhong999@163.com |
Affiliation:
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Jiangsu Province Hospital of Chinese Medicine |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Uicerative colitis
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Intervention(s)
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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;
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Primary Outcome(s)
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clinical efficacy rate;
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Secondary Outcome(s)
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laboratory index;mucosal healing rate;TCM syndrome efficacy;indicators of intestinal flora, metagenome and metabolome;endoscopic response rate;clinical remission rate;quality of life;
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Secondary ID(s)
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ChiCTR2000035099
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ChiMCTR2000003530
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Source(s) of Monetary Support
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Science and Technology Department of Jiangsu Province; Jiangsu Province Hospital of Chinese Medicine
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Ethics review
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Status: Approved
Approval date: 03/03/2020
Contact:
Xi Zou
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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