Dyspepsia Clinical Trial
Official title:
Helicobacter Pylori Eradication With Berberine Hydrochloride,Esomeprazole,Amoxicillin and Clarithromycin Versus Bismuth,Esomeprazole,Amoxicillin,and Clarithromycin: a Randomized,Open-label, Non-inferiority, Phase Ⅳ Trail
This study aims at evaluating efficacy and safety of berberine-containing quadruple therapy(berberine, esomeprazole, clarithromycin and amoxicillin) versus bismuth-containing quadruple therapy (bismuth,esomeprazole,clarithromycin and amoxicillin) in H. pylori eradication. It is hypothesized that berberine-containing quadruple therapy is non-inferior to bismuth-containing quadruple therapy. Patients with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 2 and 6 follow-up visits, a urea breath test(UBT) will be performed to confirm eradication.
The study will include three phases: screening, treatment and follow-up. Screening: this
phase will last a maximum of 28 days and subjects eligibility will be evaluated after
informed consent signature. Endoscopy and Urea Breath test will be performed in addition to
the baseline routine evaluations.
Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A
randomization visit will take place on Day 0 and an end-of-treatment visit will take place
between day 12 and 14.
Follow-up: includes two visits. approximately 14 days of treatment and 28 days after the end
of treatment. Eradication of H. Pylori will be confirmed through urea breath test(UBT).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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