Back to resultsEfficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis
Primary Purpose
Ulcerative Colitis
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
berberine
regular treatment
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis, Berberine
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
berberine group
regular treatment group
Arm Description
regular treatment and receive oral berberine 300mg three times daily untill recurrence in one year
regular treatment untill recurrence in one year
Outcomes
Primary Outcome Measures
Annual Recurrence Rate
Secondary Outcome Measures
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.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Full Information
NCT ID
NCT02962245
First Posted
October 14, 2016
Last Updated
January 30, 2023
Sponsor
Xijing Hospital of Digestive Diseases
1. Study Identification
Unique Protocol Identification Number
NCT02962245
Brief Title
Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis
Official Title
Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis: An Open-label,Randomized,Phase IV Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funds
Study Start Date
November 2016 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital of Digestive Diseases
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative Colitis, Berberine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
berberine group
Arm Type
Active Comparator
Arm Description
regular treatment and receive oral berberine 300mg three times daily untill recurrence in one year
Arm Title
regular treatment group
Arm Type
Placebo Comparator
Arm Description
regular treatment untill recurrence in one year
Intervention Type
Drug
Intervention Name(s)
berberine
Intervention Type
Drug
Intervention Name(s)
regular treatment
Intervention Description
such as 5-ASA,immunomodulating/suppressive agents or Anti-TNF therapy
Primary Outcome Measure Information:
Title
Annual Recurrence Rate
Time Frame
a year
Secondary Outcome Measure Information:
Title
Disease exacerbation rate measured by Mayo Clinic disease activity index scores
Description
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.
Time Frame
a year
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Time Frame
a year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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.
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis
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