Study of Berberine Hydrochloride in Prevention of Colorectal Adenomas Recurrence

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Placebo-controlled, Multicenter, Prospective Clinical Study of Berberine Hydrochloride in Preventing Recurrence and Carcinogenesis After Endoscopic Removal of Colorectal Adenomas

Conditions
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Colorectal Adenoma

Intervention / Treatment
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* Drug: Berberine hydrochloride
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Berberine hydrochloride<br>supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years | Drug: Berberine hydrochloride<br>* supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years<br>|
| Placebo Comparator: placebo<br>identical-appearing placebo supplements for 2-3 years | Drug: placebo<br>* supplement of placebo two times per day for 2-3 years<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rates of CRA | The primary objective of this study is to investigate recurrence rates of colorectal adenoma (CRA) after Berberine hydrochloride or placebo intervention. | until the last patient reached the 2 years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of all polypoid lesions or advanced colorectal adenoma or colorectal cancer | The incidence of all polypoid lesions or advanced colorectal adenoma or colorectal cancer after Berberine hydrochloride or placebo intervention | until the last patient reached the 2 years follow-up |