Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis: An Open-label,Randomized,Phase IV Clinical Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- Annual Recurrence Rate
Study Overview
Brief Summary
The research aim to find out whether berberine can reduce the annual recurrence rate of ulcerative colitis in remission.
A total of 238 patients with ulcerative colitis in remission will be randomly divided into two groups.One will receive regular treatment,and the other group will receive extra oral berberine 300 mg three times daily for a year.
The end of the study for every patient is disease recurrence(Mayo Clinic score of 3 points or more ).
The primary analysis is annual recurrence rate, and both endoscopy and Mayo Clinic disease activity index scores at the baseline and final assessments.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis with ulcerative colitis(according to the second European evidence-based consensus on the diagnosis and management of ulcerative colitis);
- •Disease remission of ulcerative colitis(a total Mayo Clinic score of 2 points or less and an endoscopic score of 1 point or less);
- •Diagnosis of moderate or severe ulcerative colitis within 3 months(a total Mayo Clinic score of 6-12 points)
Exclusion Criteria
- •Prior bowel resection surgery;
- •Women who are planning or actual pregnancy or lactation during study period;
- •Patients allergic to berberine;
- •History of disease that would interfere with their participation in the trial, including malignant diseases, bleeding disorders, active gastric or active duodenal ulcers, autoimmune diseases, and mental or emotional disorder;
- •Take the following treatment:
- •Unstable dose of 5-ASA drugs (oral and/or rectal route) within 14 days prior to screening;
- •Unstable dose of any immunomodulating/suppressive agents and any Anti-TNF therapy within 3 months prior to screening;
- •Traditional Chinese Medicine for the treatment of UC (any pharmaceutical form) within 7 days prior to screening.
Arms & Interventions
berberine group
regular treatment and receive oral berberine 300mg three times daily untill recurrence in one year
Intervention: berberine (Drug)
regular treatment group
regular treatment untill recurrence in one year
Intervention: regular treatment (Drug)
berberine group
regular treatment and receive oral berberine 300mg three times daily untill recurrence in one year
Intervention: regular treatment (Drug)
Outcomes
Primary Outcomes
Annual Recurrence Rate
Time Frame: a year
Secondary Outcomes
- Disease exacerbation rate measured by Mayo Clinic disease activity index scores(a year)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.03(a year)
Investigators
Yongquan Shi
professor
Xijing Hospital of Digestive Diseases