ulcerative colitis.
Conditions
Interventions
experimental group:Ursodeoxycholic Acid
control group:placebo
Sponsors
The First Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age: >=18 years old, gender is not limited; 2. Meet the diagnostic criteria for mild-moderate UC: meet the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023-Xi'an), with a disease duration of >=3 months; and a Modified Mayo Score of 4 to 7 (with endoscopic items >=2 and blood in stool items >=1, as detailed in Exhibit 1); 3. The patient is receiving a stable 5-ASA preparation that meets the recommendations of the clinical practice guidelines, as follows: a) For patients receiving oral 5-ASA preparation (with or without combination of topical treatments), the type, dose, and usage of the oral preparation must have remained stable for at least 4 weeks prior to the screening visit, and, in the case of combination treatments, the topical preparation must also have remained stable for at least 2 weeks. b) For patients receiving only topical 5-ASA agents, the type, dose and administration of the topical agent must have been stable for at least 2 weeks prior to screening; 4. voluntarily sign the informed consent form and be able to co-operate in completing all follow-up visits and examinations.
Exclusion criteria
Exclusion criteria: 1. Concurrent intestinal disorders (e.g., Crohn's disease, intestinal tuberculosis, intestinal tumours, infectious colitis), prior history of colectomy, or severe dysfunction of vital organs including heart, liver, or kidneys; 2. Allergy to UDCA or placebo components, or contraindications to UDCA use (e.g., acute cholecystitis and cholangitis, biliary obstruction, recurrent biliary colic); 3. Recent use of antibiotics within the past 2 weeks, systemic or rectal steroids within the past 4 weeks, or immunosuppressants/biological agents within the past 12 weeks; current or planned use of bile acid sequestrants (e.g., cholestyramine) or aluminium-containing antacids during the study period; Individuals who have initiated, discontinued, or adjusted any regular antidepressant/anxiolytic medication or psychotherapy within 12 weeks prior to screening or during the study period; 4. History of severe psychiatric disorders such as epilepsy, schizophrenia, or bipolar disorder; 5. Pregnant or breastfeeding women, or those planning pregnancy; 6. Other circumstances deemed unsuitable for inclusion by the investigator (e.g., communication difficulties).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| UC Clinical Remission Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence rate and severity of adverse events.;The incidence rate and severity of abnormal vital signs.;The incidence rate and severity of abnormalities in standard laboratory test results.;clinical remission rate of anxiety;UC Histological Improvement Rate;degree of improvement in depression;clinical remission rate of depression;UC Histological-Endoscopic Mucosal Improvement Rate;The incidence rate and severity of serious adverse events.;UC Endoscopic Improvement Rate;The incidence rate and severity of adverse events of special interest.;UC Endoscopic Remission Rate;Degree of improvement in quality of life;Degree of change in inflammatory markers;The incidence rate and severity of adverse events leading to drug discontinuation.;degree of improvement in anxiety;UC Clinical Response Rate;UC Symptom Remission Rate; | — |
Countries
China
Contacts
Public ContactChai Jin
The First Affiliated Hospital of Army Medical University
Outcome results
None listed