Uicerative colitis
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| clinical efficacy rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| laboratory index;mucosal healing rate;TCM syndrome efficacy;indicators of intestinal flora, metagenome and metabolome;endoscopic response rate;clinical remission rate;quality of life; | — |
Countries
China
Contacts
Jiangsu Province Hospital of Chinese Medicine