Ulcerative colitis
Conditions
Interventions
UC large intestine dampness-heat syndrome group:NA
UC spleen deficiency and dampness obstruction group:NA
UC large intestine dampness-heat syndrome administration group:During the treatment period, the patients will be given the Qingchang Xiaopi Decoction. The formula is asked to decocted in purified wate
Sponsors
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Clinical cohort study (1) The inclusion criteria for the healthy controls are as follows: ? Age between 18 and 75 years old, both male or female; ? Individuals with a history of cardiovascular and cerebrovascular diseases, diabetes, hypertension, hyperlipidemia, or organic gastrointestinal diseases; ? Individuals who have signed the informed consent form. (2) The inclusion criteria for UC patients with spleen deficiency and dampness obstruction syndrome or large intestine dampness-heat syndrome are as follows: ? Age between 18 and 75 years old, both male or female; ? UC patients who meet the diagnostic criteria of the Consensus Opinion on the Diagnosis and Treatment of Inflammatory Bowel Disease issued by the Inflammatory Bowel Group of the Gastroenterology Branch of the Chinese Medical Association in 2018; ? UC patients who meet the criteria for differentiation of the large intestine dampness-heat syndrome or the spleen deficiency and dampness obstruction syndrome in the Expert Consensus on TCM Diagnosis and Treatment of Ulcerative Colitis issued by the Gastroenterology Branch of the Chinese Association of Traditional Chinese Medicine in 2017; ? Patients with mild to moderate active UC as defined by the modified Mayo score system; ? Patients who have signed the informed consent form. 2.Single arm clinical study The inclusion criteria for UC patients with large intestine damp-heat syndrome are as follows: ?Age between 18 and 75 years old, both male or female; ?UC patients who meet the diagnostic criteria of the Consensus Opinion on the Diagnosis and Treatment of Inflammatory Bowel Disease issued by the Inflammatory Bowel Group of the Gastroenterology Branch of the Chinese Medical Association in 2018; ?UC patients who meet the criteria for differentiation of large intestine damp-heat syndrome in the Expert Consensus Opinion on TCM Diagnosis and Treatment of Ulcerative Colitis issued by the Gastroenterology Branch of the Chinese Association of Traditional Chinese Medicine in 2017; ?Patients with mild to moderate active UC as defined by the modified Mayo score system; ?Patients who have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Clinical cohort study (1) The exclusion criteria for healthy people are as follows: ? Age less than 18 years old or more than 75 years old ? Patients with a history of cardiovascular and cerebrovascular diseases, diabetes, hypertension, hyperlipidemia, or organic intestinal lesions; ? Lactating women and pregnant women; ? Patients with serious primary diseases of heart, lung, liver, kidney and haematopoietic system or mental disorder; ? Persons with disabilities defined by law (dumb, deaf, blind, mentally handicapped, physically handicapped, mentally handicapped); ? Patients with cognitive and literacy impairments who were unable to actively cooperate with participants in the investigation. (2) The exclusion criteria for UC patients with spleen deficiency and dampness obstruction syndrome or large intestine dampness and heat syndrome were as follows: ? Age less than 18 years old or more than 75 years old; ? Patients with chronic schistosomiasis, bacillary dysentery, intestinal tuberculosis and other infectious colitis, colonic Crohn's disease, radiation enteritis, ischemic enteritis; ? Lactating women and pregnant women; ? Patients with serious primary diseases of the heart, lung, liver, kidney and hematopoietic system or mental disorders; ? Patients with severe complications such as local stenosis, toxic megacolon, intestinal obstruction, colon cancer, rectal cancer, intestinal perforation and anal disease; ? Patients who do not belong to large intestine dampness-heat syndrome or spleen deficiency and dampness obstruction syndrome after syndrome differentiation; ? Persons with disabilities defined by law (dumb, deaf, blind, mentally handicapped, physically handicapped, mentally handicapped); ? Patients with cognitive and literacy impairments who were unable to actively cooperate with participants in the investigation. 2.Single arm clinical study The exclusion criteria for patients with UC large intestine damp-heat syndrome are as follows: ?Age less than 18 years old or more than 75 years old; ?Patients with chronic schistosomiasis, bacillary dysentery, intestinal tuberculosis and other infectious colitis, colonic Crohn's disease, radiation enteritis, ischemic enteritis; ? Lactating women and pregnant women; ?Patients with serious primary diseases of the heart, lung, liver, kidney and hematopoietic system or mental disorders; ?Patients with severe complications such as local stenosis, toxic megacolon, intestinal obstruction, colon cancer, rectal cancer, intestinal perforation and anal disease; ?Patients who do not belong to large intestine damp-heat syndrome after syndrome differentiation; ?Persons with disabilities defined by law (dumb, deaf, blind, mentally handicapped, physically handicapped, mentally handicapped); ?Patients with cognitive and literacy impairments who were unable to actively cooperate with participants in the investigation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mayo score;Traditional Chinese Medicine Syndrome Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| inflammatory bowel disease questionnaire;Patient Health Questionnaire – 9;7-tiem Generalized Anxiety Disorder Scale,GAD-7;Dampness Syndrome Assessment Scale;routine blood test;Urine routine examination;Stool routine examination;Calprotectin;ESR;C reactive protein;hepatic and renal function tests;endoscopic examination and pathological examination;flow cytometric analysis;metabolomic analysis;transcriptomic analysis;metagenomic analysis;Single Cell Analysis; electrocardiogram;Cytokine tests; | — |
Countries
China
Contacts
Public ContactShaogang Huang
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Outcome results
None listed