Health Condition 1: K279- Peptic ulcer, site unspecified, unspecified as acute or chronic, without hemorrhage or perforation
Conditions
Interventions
Intervention1: Vonoprazan based triple therapy: Vonoprazan fumarate 20 mg twice daily + Amoxicillin 1000 mg twice daily + Clarithromycin 500 mg twice daily orally for 14 days
Control Intervention1: Pa
Sponsors
Dr Sahil Hudda
Eligibility
Inclusion criteria
Inclusion criteria: Confirmed H pylori infection by Rapid Urease Test and or histopathology on endoscopic biopsy Has at least 1 of the following clinical conditions dyspepsia a recent or new diagnosis of nonbleeding peptic ulcer history of peptic ulcer not previously treated for H pylori infection Treatment naive patients for H pylori Willing to give written informed consent Able to comply with study protocol and follow-up
Exclusion criteria
Exclusion criteria: Prior H pylori eradication therapy Use of antibiotics within 4 weeks prior to enrollment Known allergy or hypersensitivity to Vonoprazan pantoprazole amoxicillin or clarithromycin Pregnancy and lactation Severe hepatic impairment Severe renal impairment Patients on drugs with significant interactions warfarin clopidogrel methotrexate History of previous gastric surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether Vonoprazan based triple drug therapy provides significant Helicobacter pylori eradication results compared to pantoprazole-based triple drug therapy as assessed by eradication rate confirmed on stool antigen test in patients with confirmed Helicobacter pylori infection attending a tertiary care hospital in eastern tribal GujaratTimepoint: At 3rd follow-up week 6 the following will be assessed Confirmation of eradication stool antigen test | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the adverse drug reaction profile between the two treatment groups To evaluate symptomatic relief using Glasgow Dyspepsia Severity Score and To compare the direct drug cost of both regimens as a pharmacoeconomic analysisTimepoint: At 1st and 2nd followup Day7 and 14 the following will be assessed Clinical evaluation symptom relief Assessment of drug compliance Monitoring of adverse events At 3rd follow-up week 6 the following will be assessed Clinical evaluation symptom relief Assessment of drug compliance Monitoring of adverse events | — |
Countries
India
Contacts
Public ContactDr Sahil Hudda
Zydus Medical College and Hospital
Outcome results
None listed