Study of Berberine Hydrochloride in Prevention of Colorectal Adenomas Recurrence

Shanghai Jiao Tong University School of Medicine

Status and phase: Completed; Phase 3; Phase 2

Conditions: Colorectal Adenoma

Treatments: Drug: placebo; Drug: Berberine hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT02226185

RJ2014BH

Details and patient eligibility

About

Berberine hydrochloride is a conventional component in Chinese medicine. In recent years, anticancer activity of berberine hydrochloride have been explored. The aim of this study is to investigate the effect of berberine hydrochloride on the recurrence of colorectal adenomas.

Full description

Colorectal adenomas are well-known to be precancerous lesions that develop into colorectal cancers on the basis of the adenoma-carcinoma sequence. The effects of screening for colorectal adenomas and removing precancerous lesions on the prevention of colorectal cancer have been established. Because of the high recurrence rates of colorectal adenomas in patients who have undergone polypectomy, the potential chemopreventive agents that may reduce the risk of colorectal adenoma recurrence need to be investigated.

Berberine hydrochloride is a conventional component in Chinese medicine. In recent years, anticancer activity of berberine hydrochloride have been explored. The aim of this study is to investigate the effect of berberine hydrochloride on the recurrence of colorectal adenomas by conducting a randomized, placebo-controlled, prospective clinical.

Enrollment: 1,108 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Individuals aged 18-75 years
• Individuals who had at least one and no more than 6 histologically confirmed CRAs removed within 6 months before recruitment
• Individuals who are able to swallow pills
• Individuals who voluntarily sign the consent form after being fully informed and understanding the purpose and procedure of this study, characters of the disease, effect of medication, methods of related examinations, and potential risk/benefits of the study 4.2 Exclusion criteria
• Individuals whose adenoma was not completely removed during previous colonoscopy
• Individuals with a history of familial adenomatous polyposis (FAP) or hereditary non-polyposis colorectal cancer (HNPCC, Lynch syndrome)
• Individuals who are taking regularly aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), cyclo-oxygenase 2 (COX2) inhibitors, calcium or vitamin D
• Individuals with a history of subtotal/total gastrectomy or partial bowel resection
• Individuals who are intolerant to another colonoscopy examination
• Individuals who are hypersensitive or intolerant to the drugs
• Individuals with severe heart, liver or kidney disease, or any cancer history
• Individuals presenting severe constipation
• Pregnant women, women during breast-feeding period, or women with expect pregnancy
• Individuals with mental diseases who are not able to cooperate
• Individuals who are involved in designing, planning or performing this trial

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,108 participants in 2 patient groups, including a placebo group

Berberine hydrochloride

Experimental group

Description:

supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years

Treatment:

Drug: Berberine hydrochloride

placebo

Placebo Comparator group

Description:

identical-appearing placebo supplements for 2-3 years

Treatment:

Drug: placebo