Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis
NCT02962245 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL
Last updated 2023-02-01
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
Interventions
- DRUG
-
berberine
- DRUG
-
regular treatment
such as 5-ASA,immunomodulating/suppressive agents or Anti-TNF therapy
Sponsors & Collaborators
-
Xijing Hospital of Digestive Diseases
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-11-30
- Primary Completion
- 2018-01-31
- Completion
- 2018-01-31
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