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Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT02962245
Recruitment Status : Unknown
Verified November 2016 by Yongquan Shi, Xijing Hospital of Digestive Diseases.
Recruitment status was:  Not yet recruiting
First Posted : November 11, 2016
Last Update Posted : November 11, 2016
Sponsor:
Information provided by (Responsible Party):
Yongquan Shi, Xijing Hospital of Digestive Diseases

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.


Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: berberine Drug: regular treatment Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis: An Open-label,Randomized,Phase IV Clinical Trial
Study Start Date : November 2016
Estimated Primary Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: berberine group
regular treatment and receive oral berberine 300mg three times daily untill recurrence in one year
Drug: berberine
Drug: regular treatment
such as 5-ASA,immunomodulating/suppressive agents or Anti-TNF therapy

Placebo Comparator: regular treatment group
regular treatment untill recurrence in one year
Drug: regular treatment
such as 5-ASA,immunomodulating/suppressive agents or Anti-TNF therapy




Primary Outcome Measures :
  1. Annual Recurrence Rate [ Time Frame: a year ]

Secondary Outcome Measures :
  1. Disease exacerbation rate measured by Mayo Clinic disease activity index scores [ Time Frame: a year ]
    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.

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: a year ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Yongquan Shi, professor, Xijing Hospital of Digestive Diseases
ClinicalTrials.gov Identifier: NCT02962245     History of Changes
Other Study ID Numbers: KY20162062-1
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: November 11, 2016
Last Verified: November 2016
Keywords provided by Yongquan Shi, Xijing Hospital of Digestive Diseases:
Ulcerative Colitis
Berberine
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Benzocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents