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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035099
Enrollment
Unknown
Registered
2020-07-31
Start date
2020-08-01
Completion date
Unknown
Last updated
2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uicerative colitis

Interventions

Sponsors

Jiangsu Province Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
clinical efficacy rate;

Secondary

MeasureTime frame
clinical remission rate;endoscopic response rate;mucosal healing rate;TCM syndrome efficacy;indicators of intestinal flora, metagenome and metabolome;laboratory index;quality of life;

Countries

China

Contacts

Public ContactHong Shen

Jiangsu Province Hospital of Chinese Medicine

shenhong999@163.com+86 13851872859

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026