Ulcerative ColitisPhase 4NCT02962245
Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis
A Phase 4 study testing berberine and regular treatment in people with Ulcerative Colitis, run by Xijing Hospital of Digestive Diseases.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- berberine and regular treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Jan 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
About this study
Official title: Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis: An Open-label,Randomized,Phase IV Clinical Trial
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
- Ulcerative Colitis
- Being tested
- berberine, regular treatment
- Keywords
- Ulcerative Colitis, Berberine
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
berberineDrug
regular treatmentDrug
such as 5-ASA,immunomodulating/suppressive agents or Anti-TNF therapy
| Study group | Role | What they receive |
|---|---|---|
| berberine group | Active comparator | regular treatment and receive oral berberine 300mg three times daily untill recurrence in one year Receives: Drug: berberine; Drug: regular treatment |
| regular treatment group | Placebo comparator | regular treatment untill recurrence in one year Receives: Drug: regular treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual Recurrence Rate
Measured: a year
Secondary outcomes (2)
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.
Measured: a year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Measured: a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionJan 2018
- Study completionJan 2018
Why it stopped: Lack of funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongquan Shi, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962245
- Sponsor's protocol ID
- KY20162062-1
- Status last verified
- Jan 2023
- First submitted
- 14 Oct 2016
- Last updated
- 1 Feb 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis: An Open-label,Randomized,Phase IV Clinical Trial
- ClinicalTrials.gov ID
- NCT02962245
- Acronym / sponsor ID
- KY20162062-1
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative Colitis, Berberine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| berberine group | Active comparator | Drug: berberine, Drug: regular treatmentregular treatment and receive oral berberine 300mg three times daily untill recurrence in one year |
| regular treatment group | Placebo comparator | Drug: regular treatmentregular treatment untill recurrence in one year |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| berberine | Drug | berberine group |
| regular treatmentsuch as 5-ASA,immunomodulating/suppressive agents or Anti-TNF therapy | Drug | berberine group, regular treatment group |
Primary outcome
Annual Recurrence Rate
Time frame: a year
2 secondary outcomes
Disease exacerbation rate measured by Mayo Clinic disease activity index scores
Time frame: a year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Time frame: a year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing berberine and regular treatment in people with Ulcerative Colitis, run by Xijing Hospital of Digestive Diseases.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual Recurrence Rate (time frame: a year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.