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NCT Number: NCT02226185

Study of Berberine Hydrochloride in Prevention of Colorectal Adenomas Recurrence

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.

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Key information

Conditions

Colorectal Adenoma

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Gastroenterology, the Seventh Medical Center of PLA General Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Berberine Hydrochloride

Drug

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

Placebo

Drug

supplement of placebo two times per day for 2-3 years

Primary outcomes

  1. Recurrence rates of CRA

    Time frame: until the last patient reached the 2 years follow-up

    The primary objective of this study is to investigate recurrence rates of colorectal adenoma (CRA) after Berberine hydrochloride or placebo intervention.

Secondary outcomes

  1. The incidence of all polypoid lesions or advanced colorectal adenoma or colorectal cancer

    Time frame: until the last patient reached the 2 years follow-up

    The incidence of all polypoid lesions or advanced colorectal adenoma or colorectal cancer after Berberine hydrochloride or placebo intervention

Other outcomes

  1. Changes in fecal microflora

    Time frame: baseline, the 1st year and the 2nd year

    Fecal microflora tests

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Aug 27, 2014
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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