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ID06629051

A Multicenter, Placebo-controlled Clinical Study of Berberine Hydrochloride in Preventing Recurrence and Carcinogenesis After Endoscopic Removal of Colorectal Adenomas: 6-year Retrospective Follow-up Data

Led by Shanghai Jiao Tong University School of Medicine · Updated on 2024-10-08

891

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

S

Shanghai Jiao Tong University School of Medicine

Lead Sponsor

S

Seventh Medical Center of PLA Army General Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Colorectal cancer is a common and serious disease that often develops from precursor growths called adenomatous polyps. This study evaluates the long-term effects of berberine hydrochloride, a drug previously shown to reduce recurrence of these polyps after removal. Researchers aim to see if the protective effects of berberine continue for up to six years after patients stop taking the medication. The study observes patients who were part of an earlier trial where they received either berberine or a placebo. It compares the recurrence rates of colorectal adenomas and other types of polyps at multiple intervals: within the first year, between one and three years, and between three and six years after stopping the drug. This retrospective follow-up helps assess berberine's long-term preventive effects. Participants will be monitored through medical records to track the recurrence of colorectal adenomas and other polyps over six years. Researchers will analyze outcomes such as the rate of traditional adenoma recurrence and the incidence of hyperplastic and serrated polyps. This study provides important information about the lasting impact of berberine on colorectal polyp recurrence after endoscopic removal.

CONDITIONS

Brief Title

6-year Follow-up Data After the Berberine Intervention Trial

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants who completed the previous berberine intervention study (NCT02226185)
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Long-term Monitoring

Duration - 6 years

Participants are observed for recurrence and incidence of colorectal adenomas and other polyps after prior intervention with berberine or placebo.

Trial Site Locations

Total: 1 location

1

Renji Hospital, Shanghai Jiao-Tong University School of Medicine

Shanghai, China, 200127

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Research Team

J

Jing-Yuan Fang, Professor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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