Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis: An Open-label,Randomized,Phase IV Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02962245
• Other study ID #: KY20162062-1
• Status: Withdrawn
• Phase: Phase 4
• Start date: November 2016
• Est. completion date: January 2018

Study information

• Verified date: January 2023
• Source: Xijing Hospital of Digestive Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• berberine

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital of Digestive Diseases

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annual Recurrence Rate		a year
Secondary	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.	a year
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.03		a year