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Primary Chemoprevention of Familial Adenomatous Polyposis With Berberine Hydrochloride

NCT03333265 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-07-27

No results posted yet for this study

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. The aim of this study is to investigate the chemopreventive effects Berberine hydrochlorid on the regression of colorectal adenomas.

Conditions

  • Colorectal Adenomas

Interventions

DRUG

100mg Berberine hydrochloride

patients take the Berberine hydrochloride 100mg tablet by mouth, 2 times a day with 6 months

DRUG

300mg Berberine hydrochloride

patients take the Berberine hydrochloride 300mg tablet by mouth, 2 times a day with 6 months

DRUG

Placebo Oral Tablet

patients take mmic Berberine hydrochloride tablet by mouth, 2 times a day with 6 months

Sponsors & Collaborators

  • Xijing Hospital of Digestive Diseases

    lead OTHER

Principal Investigators

  • Weizhong Wang, MD,PH.D · Xijing digestive surgery center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2020-08-31
Completion
2021-06-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03333265 on ClinicalTrials.gov