ulceractive colitis
Conditions
Interventions
Gold Standard:According to the Consensus on the Diagnosis and Treatment of Inflammatory Bowel Disease released by the the Inflammatory Bowel Disease Group of the Division of Gastroenterology, Chinese
Index test:Traditional Chinese Medicine Syndrome Score
Assessment scales such as Inflammatory Bowel Disease Quality of Life Rating Scale
Clinical physicochemical indicators such as routine blood analysis
endoscopic examination and pathological examination
metagenomic analysis
single-cell analysis, etc.
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: a. Age greater than or equal to 18 years old. b. Patients comply with the diagnostic criteria of the Dampness-Related Syndrome of Chinese Medicine and the diagnosis of ulcerative colitis, which was formulated according to the Consensus Opinions on the Diagnosis and Treatment of Inflammatory Bowel Diseases issued by the Inflammatory Bowel Disease Group of the Division of Digestive Diseases of the Chinese Medical Association in 2012. c. Patients with ulcerative colitis diagnosed as having dampness-related syndrome according to the diagnostic criteria for dampness-related syndrome established in the previous phase of this study.
Exclusion criteria
Exclusion criteria: a. Patients with chronic schistosomiasis, bacillary dysentery, intestinal tuberculosis colonic-type Crohn's disease, radiation enteritis, or ischemic enteritis. b. Pregnant or lactating women, or those who plan to get pregnant within 1 year. c. Patients with severe primary diseases of respiratory system, circulatory system, endocrine system and urinary system, which cannot be controlled by conventional medication. d.Patients with severe infections, hepatitis, tuberculosis, lymphocytosis, hematopoietic system abnormality or tumors. e. Patients with severe disorders of water, electrolyte and acid-base balance; patients with primary or secondary immunodeficiency and hypersensitivity. f. Patients who are participating in clinical trials of other drugs or who have participated in other clinical trials within 1 month. g. Patients who are not suitable for inclusion in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sensitivity;specificity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine Syndrome Score;inflammatory bowel disease questionnaire;7-tiem Generalized Anxiety Disorder Scale,GAD-7;Patient Health Questionnaire – 9;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
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed