Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis

Phase 4

Withdrawn

• Conditions: Ulcerative Colitis
• Interventions: Drug: berberine; Drug: regular treatment

• Registration Number: NCT02962245
• Lead Sponsor: Xijing Hospital of Digestive Diseases

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-14
• Study Start: 2016-11
• Study First Submitted QC: 2016-11-10
• Study First Posted: 2016-11-11
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-02-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Diagnosis with ulcerative colitis(according to the second European evidence-based consensus on the diagnosis and management of ulcerative colitis);
2. Disease remission of ulcerative colitis(a total Mayo Clinic score of 2 points or less and an endoscopic score of 1 point or less);
3. Diagnosis of moderate or severe ulcerative colitis within 3 months(a total Mayo Clinic score of 6-12 points)

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Exclusion Criteria

1. Prior bowel resection surgery;

2. Women who are planning or actual pregnancy or lactation during study period;

3. Patients allergic to berberine;

4. 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;

5. 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
berberine group	regular treatment	regular treatment and receive oral berberine 300mg three times daily untill recurrence in one year
regular treatment group	regular treatment	regular treatment untill recurrence in one year
berberine group	berberine	regular treatment and receive oral berberine 300mg three times daily untill recurrence in one year

Primary Outcome Measures

Name	Time	Method
Annual Recurrence Rate	a year

Secondary Outcome Measures

Name	Time	Method
Disease exacerbation rate measured by Mayo Clinic disease activity index scores	a year	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.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03	a year