Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis

NCT02962245 | Withdrawn Phase 4

• 1 other identifier: KY20162062-1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

Ulcerative Colitis; Berberine

Outcome Measures

Primary Outcomes (1)

• Annual Recurrence Rate

  a year

Secondary Outcomes (2)

• 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

Study Arms (2)

berberine group

ACTIVE COMPARATOR

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

Drug: berberine; Drug: regular treatment

regular treatment group

PLACEBO COMPARATOR

regular treatment untill recurrence in one year

Drug: regular treatment

Interventions

berberine DRUG

berberine group

regular treatment DRUG

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

berberine group; regular treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Berberine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 14, 2016
• First Posted: November 11, 2016
• Study Start: November 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: February 1, 2023

Record last verified: 2023-01