Status:
COMPLETED
Primary Chemoprevention of Familial Adenomatous Polyposis With Berberine Hydrochloride
Lead Sponsor:
Xijing Hospital of Digestive Diseases
Conditions:
Colorectal Adenomas
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief 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...
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 b...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03333265
Start Date
September 1 2017
End Date
June 1 2021
Last Update
July 27 2022
Active Locations (1)
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1
Li
Xi'an, Shaanxi, China, 710000