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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
such as 5-ASA,immunomodulating/suppressive agents or Anti-TNF therapy
Annual Recurrence Rate
Time frame: a year
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.
Time frame: a year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Time frame: a year
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