Colorectal AdenomasPhase 2/3NCT03333265
Primary Chemoprevention of Familial Adenomatous Polyposis With Berberine Hydrochloride
A Phase 2/3 study testing 100mg Berberine hydrochloride and 300mg Berberine hydrochloride in people with Colorectal Adenomas, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
In recent years, Berberine hydrochloride has been reported to inhibit cancer cell proliferation and to be cytotoxic towards cancer cells. Patients with familial adenomatous polyposis have a nearly 100 percent risk of colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Colorectal Adenomas
- What is being tested?
- 100mg Berberine hydrochloride and 300mg Berberine hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 1 Jun 2021
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-65 years
- Patients with familial adenomatous polyposis, who had not had their entire colorectum removed, and who had five or more polyps 2 mm or more in diameter that could be assessed endoscopically
- All potential subjects received genetic counseling before undergoing genetic testing for APC gene mutations.
- Eligible subjects had a disease-causing mutation of the APC gene but had no endoscopically detectable colorectal adenomatous polyps and no history of colonic surgery
Who cannot join
- Patients who are hypersensitive or intolerant to the drugs
- Patients who had a history of colectomy or colectomy anticipated within 8 months after randomization
- Patients with abnormal results of serum laboratory tests (a white-cell count of less than 4000 per cubic millimeter, a platelet count of less than 100,000 per cubic millimeter, a blood urea nitrogen level of more than 25 mg per deciliter (8.9 mmol per liter), a serum creatinine level of more than 1.5 mg per deciliter (132.6 µmol per liter))
- Patients with diabetes mellitus, severe renal disease or cardiovascular disease (defined by a New York Heart Association functional classof III or IV)
- Patients with hypercalcemia or urolithiasis
- Patients with hemolytic anemia and glucose -6- phosphate dehydrogenase deficiency
Show all 14Show fewer
- Patients had clinically obvious narcotic or alcohol dependence during the previous 6 months
- Patients had used NSAIDs including aspirin at any dose on 3 or more days per month during each of the 3 months before enrollment or for a period of 36 days in the previous year; or had a history of stroke, transient ischemic attacks, angina, myocardial infarction, or atherosclerotic peripheral vascular disease
- Pregnant women, women during breast-feeding period, or women with expect pregnancy
- Patients with a history of subtotal gastrectomy or partial bowel resection
- Patients who are not able to cooperate
- Individual who are involved in designing, planning or performing this clinical trial
- Patients with medical conditions who are not appropriate to participate the study
- Patients with any condition that could be worsened by supplemental Berberine hydrochloride
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Berberine Hydrochloride in Familial Adenomatous Polyposis:a Prospective, Randomized, Double Blind, Placebo-controlled, Multicenter Clinical Trial
In recent years, Berberine hydrochloride has been reported to inhibit cancer cell proliferation and to be cytotoxic towards cancer cells. Patients with familial adenomatous polyposis have a nearly 100 percent risk of colorectal cancer. The aim of this study is to investigate the chemopreventive effects Berberine hydrochlorid on the regression of colorectal adenomas.
Read the detailed description
Familial adenomatous polyposis is an autosomal dominant syndrome caused by a germ-line mutation of the adenomatous polyposis coli (APC) gene located at chromosome 5q21. The disorder is characterized by the development of hundreds of colorectal adenomas during adolescence. Colorectal cancer will develop in nearly all affected persons by the sixth decade of life if prophylactic colectomy is not performed. Because the adenoma-to-carcinoma sequence in familial adenomatous polyposis resembles sporadic colon carcinogenesis, studies of familial adenomatous polyposis may contribute to the prevention of sporadic adenomas and colon cancer.
BBR, an isoquinoline alkaloid, is a natural compound in numerous Chinese herb plants such as Berberisaristata, Coptischinensis, Coptis rhizome, etc. In recent years, Berberine hydrochloride has been reported to inhibit cancer cell proliferation and to be cytotoxic towards cancer cells. The aim of this study is to investigate the regression effect of Berberine hydrochloride on the colorectal adenomas in patients with familial adenomatous polyposis.
- Conditions
- Colorectal Adenomas
- Being tested
- 100mg Berberine hydrochloride, 300mg Berberine hydrochloride, Placebo Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100mg Berberine hydrochlorideDrug
Also called 100mg Berberine hydrochloride tablet ("Sine Tianping")
patients take the Berberine hydrochloride 100mg tablet by mouth, 2 times a day with 6 months
300mg Berberine hydrochlorideDrug
Also called 300mg Berberine hydrochloride tablet ("Sine Tianping")
patients take the Berberine hydrochloride 300mg tablet by mouth, 2 times a day with 6 months
Placebo Oral TabletDrug
Also called Placebo (for Berberine hydrochloride)
patients take mmic Berberine hydrochloride tablet by mouth, 2 times a day with 6 months
| Study group | Role | What they receive |
|---|---|---|
| 100mg Berberine hydrochloride group | Experimental | Berberine hydrochloride 100mg tablet by mouth, two times per day for 6 months Receives: Drug: 100mg Berberine hydrochloride |
| 300mg Berberine hydrochloride group | Experimental | Berberine hydrochloride 300mg tablet by mouth, two times per day for 6 months Receives: Drug: 300mg Berberine hydrochloride |
| Placebo oral tablets | Placebo comparator | identical-appearing placebo tablets by mouth, two times per day for 6 months Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative the numbers and diameters of those colorectal adenomas during Berberine hydrochloride or placebo treatment in patients with familial adenomatous polyposis
The primary objective of this study is to investigate the number and diameters of colorectal polyps after Berberine hydrochloride or placebo intervention. To ascertain that the same area was scored at base line and at month 6, polyps were counted in pairs of photographs. One investigator, other than the endoscopist, who did not know the treatment, performed the scoring. Videotapes were used to resolve ambiguities and confirm polyp counts. The diameter of those colorectal adenomas was measured in millimeters with a graduated scale passed through the colonoscopy biopsy channel.
Measured: From baseline to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Sep 2017
- Primary completion31 Aug 2020
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenomasStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xiaohua li, Xijing Hospital of Digestive Diseases
- Investigators
- Weizhong Wang, MD,PH.D, Principal investigator, Xijing digestive surgery center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333265
- Sponsor's protocol ID
- XJLL 2016 017
- Status last verified
- Jul 2022
- First submitted
- 2 Nov 2017
- Last updated
- 27 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Berberine Hydrochloride in Familial Adenomatous Polyposis:a Prospective, Randomized, Double Blind, Placebo-controlled, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT03333265
- Acronym / sponsor ID
- XJLL 2016 017
- Conditions
- Colorectal Adenomas
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 6 Nov 2017 (actual)
- 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.
In recent years, Berberine hydrochloride has been reported to inhibit cancer cell proliferation and to be cytotoxic towards cancer cells. Patients with familial adenomatous polyposis have a nearly 100 percent risk of colorectal cancer. The aim of this study is to investigate the chemopreventive effects Berberine hydrochlorid on the regression of colorectal adenomas.
Detailed description
Familial adenomatous polyposis is an autosomal dominant syndrome caused by a germ-line mutation of the adenomatous polyposis coli (APC) gene located at chromosome 5q21. The disorder is characterized by the development of hundreds of colorectal adenomas during adolescence. Colorectal cancer will develop in nearly all affected persons by the sixth decade of life if prophylactic colectomy is not performed. Because the adenoma-to-carcinoma sequence in familial adenomatous polyposis resembles sporadic colon carcinogenesis, studies of familial adenomatous polyposis may contribute to the prevention of sporadic adenomas and colon cancer.
BBR, an isoquinoline alkaloid, is a natural compound in numerous Chinese herb plants such as Berberisaristata, Coptischinensis, Coptis rhizome, etc. In recent years, Berberine hydrochloride has been reported to inhibit cancer cell proliferation and to be cytotoxic towards cancer cells. The aim of this study is to investigate the regression effect of Berberine hydrochloride on the colorectal adenomas in patients with familial adenomatous polyposis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 100mg Berberine hydrochloride group | Experimental | Drug: 100mg Berberine hydrochlorideBerberine hydrochloride 100mg tablet by mouth, two times per day for 6 months |
| 300mg Berberine hydrochloride group | Experimental | Drug: 300mg Berberine hydrochlorideBerberine hydrochloride 300mg tablet by mouth, two times per day for 6 months |
| Placebo oral tablets | Placebo comparator | Drug: Placebo Oral Tabletidentical-appearing placebo tablets by mouth, two times per day for 6 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18-65 years
- Patients with familial adenomatous polyposis, who had not had their entire colorectum removed, and who had five or more polyps 2 mm or more in diameter that could be assessed endoscopically
- All potential subjects received genetic counseling before undergoing genetic testing for APC gene mutations.
- Eligible subjects had a disease-causing mutation of the APC gene but had no endoscopically detectable colorectal adenomatous polyps and no history of colonic surgery
Key exclusion criteria (14 listed)
- Patients who are hypersensitive or intolerant to the drugs
- Patients who had a history of colectomy or colectomy anticipated within 8 months after randomization
- Patients with abnormal results of serum laboratory tests (a white-cell count of less than 4000 per cubic millimeter, a platelet count of less than 100,000 per cubic millimeter, a blood urea nitrogen level of more than 25 mg per deciliter (8.9 mmol per liter), a serum creatinine level of more than 1.5 mg per deciliter (132.6 µmol per liter))
- Patients with diabetes mellitus, severe renal disease or cardiovascular disease (defined by a New York Heart Association functional classof III or IV)
- Patients with hypercalcemia or urolithiasis
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 |
|---|---|---|
| 100mg Berberine hydrochlorideAlso: 100mg Berberine hydrochloride tablet ("Sine Tianping")patients take the Berberine hydrochloride 100mg tablet by mouth, 2 times a day with 6 months | Drug | 100mg Berberine hydrochloride group |
| 300mg Berberine hydrochlorideAlso: 300mg Berberine hydrochloride tablet ("Sine Tianping")patients take the Berberine hydrochloride 300mg tablet by mouth, 2 times a day with 6 months | Drug | 300mg Berberine hydrochloride group |
| Placebo Oral TabletAlso: Placebo (for Berberine hydrochloride)patients take mmic Berberine hydrochloride tablet by mouth, 2 times a day with 6 months | Drug | Placebo oral tablets |
Primary outcome
Cumulative the numbers and diameters of those colorectal adenomas during Berberine hydrochloride or placebo treatment in patients with familial adenomatous polyposis
Time frame: From baseline to 6 months.
The primary objective of this study is to investigate the number and diameters of colorectal polyps after Berberine hydrochloride or placebo intervention. To ascertain that the same area was scored at base line and at month 6, polyps were counted in pairs of photographs. One investigator, other than the endoscopist, who did not know the treatment, performed the scoring. Videotapes were used to resolve ambiguities and confirm polyp counts. The diameter of those colorectal adenomas was measured in millimeters with a graduated scale passed through the colonoscopy biopsy channel.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
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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.
Weizhong Wang, MD,PH.D principal investigator
Xijing digestive surgery center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 100mg Berberine hydrochloride and 300mg Berberine hydrochloride in people with Colorectal Adenomas, run by Xijing Hospital of Digestive Diseases at 1 site in China.
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 4 inclusion and 14 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: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cumulative the numbers and diameters of those colorectal adenomas during Berberine hydrochloride or placebo treatment in patients with familial adenomatous polyposis (time frame: From baseline to 6 months.). 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 27 Jul 2022.