Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis

NCT ID: NCT02962245

Last Updated: 2023-02-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2018-01-31

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.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

berberine group

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

Group Type: ACTIVE_COMPARATOR

berberine

Intervention Type: DRUG

regular treatment

Intervention Type: DRUG

such as 5-ASA,immunomodulating/suppressive agents or Anti-TNF therapy

regular treatment group

regular treatment untill recurrence in one year

Group Type: PLACEBO_COMPARATOR

regular treatment

Intervention Type: DRUG

such as 5-ASA,immunomodulating/suppressive agents or Anti-TNF therapy

Interventions

berberine

Intervention Type: DRUG

regular treatment

such as 5-ASA,immunomodulating/suppressive agents or Anti-TNF therapy

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital of Digestive Diseases

OTHER

Sponsor Role: lead

Responsible Party

Yongquan Shi

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

KY20162062-1

Identifier Type: -

Identifier Source: org_study_id