Study on TCM accurate syndrome differentiation and treatment scheme of ulcerative colitis based on intestinal microecology and multi-omics technology

Phase 1

Recruiting

• Conditions: icerative colitis

• Registration Number: ITMCTR2000003530
• Lead Sponsor: Jiangsu Province Hospital of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-02-20

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified