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Study on The Efficacy and Safety of Berberine-containing Triple Therapy in Helicobacter Pylori First-Line Eradication

NCT05014334 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-01-31

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy and safety of berberine, amoxicillin and vonoprazan containing triple therapy in Helicobacter Pylori first-line eradication. It is hypothesized that berberine hydrochloride, amoxicillin and vonoprazan triple therapy is non-inferior to bismuth-containing quadruple therapy or vonoprazan -containing quadruple therapy. Patients diagnosed with H. pylori infection will be randomly divided into one of the above treatments. At week 6 follow-up visits, a urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.

Conditions

  • Helicobacter Pylori Infection
  • Chronic Gastritis

Interventions

DRUG

Berberine

berberine 500 mg, twice daily for 14 days

DRUG

Vonoprazan

Vonoprazan 20 mg, twice daily for 14 days

DRUG

Amoxicillin

amoxicillin 1000mg, twice daily for 14 days.

DRUG

Rabeprazole

Rabeprazole 10mg, twice daily for 14 days.

DRUG

Bismuth

Bismuth 220mg, twice daily for 14 days.

DRUG

Clarithromycin

clarithromy 500mg, twice daily for 14 days.

Sponsors & Collaborators

  • Xijing Hospital of Digestive Diseases

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-03-31
Completion
2022-06-30

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 NCT05014334 on ClinicalTrials.gov