Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis

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

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 Overview

• Status: Unknown
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: berberine; Drug: regular treatment

• Study Type: Interventional
• Enrollment (Anticipated): 238
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Xijing Hospital of Digestive Diseases

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: October 14, 2016
• First Submitted That Met QC Criteria: November 10, 2016
• First Posted (Estimate): November 11, 2016

Study Record Updates

• Last Update Posted (Estimate): November 11, 2016
• Last Update Submitted That Met QC Criteria: November 10, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Berberine
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: KY20162062-1