NCT02962245

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Xijing Hospital of Digestive Diseases · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	berberine
DRUG	regular treatment	such as 5-ASA,immunomodulating/suppressive agents or Anti-TNF therapy

Timeline

• Start date: 2016-11-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2016-11-11
• Last updated: 2023-02-01