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Helicobacter Pylori Eradication With Berberine Plus Amoxicillin Triple Therapy Versus Bismuth-containing Quadruple Therapy

NCT04697186 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 524

Last updated 2023-01-31

No results posted yet for this study

Summary

This study aims at evaluating efficacy and safety of berberine hydrochloride, amoxicillin and rabeprazole triple therapy versus bismuth-containing quadruple therapy(amoxicillin, clarithromycin, rabeprazole and bismuth) in the first eradication treatment of H. pylori. It is hypothesized that berberinehydrochloride, amoxicillin and rabeprazole triple therapy is non-inferior to bismuth-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

  • Dyspepsia
  • Chronic Gastritis
  • Gastric Cancer
  • Helicobacter Pylori Infection

Interventions

DRUG

Berberine

berberine , amoxicillin and rabeprazole triple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ，rabeprazole 10 mg BID.

DRUG

Amoxicillin

berberine , amoxicillin and rabeprazole triple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ，rabeprazole 10 mg BID.

DRUG

Rabeprazole

berberine , amoxicillin and rabeprazole triple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ，rabeprazole 10 mg BID.

DRUG

Amoxicillin

Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ，clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID

DRUG

Clarithromycin

Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ，clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID

DRUG

Rabeprazole

Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ，clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID

DRUG

Bismuth

Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ，clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID

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
No

Timeline & Regulatory

Start
2021-01-07
Primary Completion
2021-12-20
Completion
2021-12-20

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT04697186 on ClinicalTrials.gov