Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis

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.

Official Title
-----------------
Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis: An Open-label,Randomized,Phase IV Clinical Trial

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: berberine
* Drug: regular treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: berberine group<br>regular treatment and receive oral berberine 300mg three times daily untill recurrence in one year | Drug: berberine<br> <br> Drug: regular treatment<br>* such as 5-ASA,immunomodulating/suppressive agents or Anti-TNF therapy<br>|
| Placebo Comparator: regular treatment group<br>regular treatment untill recurrence in one year | Drug: regular treatment<br>* such as 5-ASA,immunomodulating/suppressive agents or Anti-TNF therapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annual Recurrence Rate |  | a year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease exacerbation rate measured by Mayo Clinic disease activity index scores | The primary analysis is disease exacerbation through day 14 among patients who underwent randomization, had Mayo Clinic disease activity index scores at the baseline and final assessments. Disease exacerbation is defined as a total Mayo Clinic score of 5 points or more and an increase in the endoscopic score of 1 point or more. | a year | 
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 |  | a year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ulcerative Colitis, Berberine