Helicobacter Pylori Eradication With Berberine Plus Amoxicillin Triple Therapy Versus Bismuth-containing Quadruple Therapy
Condition: Dyspepsia; Chronic Gastritis; Gastric Cancer; Helicobacter Pylori Infection
MeSH terms: Gastritis; Dyspepsia
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Detailed Description:

      The study will include three phases: screening, treatment and follow-up. Screening: this
      phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing
      informed consent. One of urea breath test，rapid urease test or helicobacter pylori stool
      antigen 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 13 and 17.

      Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication
      of H. Pylori will be confirmed by one of urea breath test，rapid urease test or helicobacter
      pylori stool antigen test.
    

Intervention name(s): Berberine; Amoxicillin; Rabeprazole; Amoxicillin; Clarithromycin; Rabeprazole; Bismuth
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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.; 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.; 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.; 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; 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; 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; 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
Other intervention name(s): Amoxy; Pariet; Amoxy; Krashen; Pariet
Intervention MeSH terms: Amoxicillin; Clarithromycin; Rabeprazole; Bismuth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Helicobacter pylori; Berberine