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IRCT20221207056738N1 IRCT 2022-12-28 National university of Medical Sciences Rawalpindi Role of Vonaprazan in H.Pylori eradication Comparison of efficacy and safety of 7-days vonoprazan versus 14-days esomeprazole based triple therapy for H- pylori infection 2022-12-20 anticipated 122 Complete https://irct.ir/trial/67382 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: there will be two groups of participants each group will contain 61 patients.one group will take 14-days triple therapy with esomeprazole 20mg BD,levofloxacin 500mg OD, amoxicillin 1000mg BD and the second group will take 7-days triple therapy with vonoprazan 20mg BD, levofloxacin 500mg OD, amoxicillin 1000mg BD. adverse effect of both therapies will be assessed at day -3 and day-14 through telephone. stool antigen test will be repeated after 28 days of the therapy, Randomization description: Patient fulfilling inclusion criteria and after giving informed consent will be included study Method of randomization will be blocks generated by computer generated software Unit of randomization will be individual there will be no stratification of data Tools used in randomization will be www.randomize.net/ Algorithms.HTML The random sequence of block will be built in 1:1 parallel number Allocation concealment will not be carried out. 3 Helicobacter pylori infection is a condition in which gram -ve bacteria called H- pylori reside in mucus lining of stomach lead to gastritis, ulcer manifest in the form of dyspepsia. Intervention 1: Intervention group: group 2 is the interventional group to which 7-days vonoprazan based triple therapy, new drug regimen, vonoprazn 20mg BD, amoxicillin 1000mg BD, levofloxacin 500mg OD for 7-days will be given. Intervention 2: Control group: Control group 1 in which 14-days esomeprazole based conventional triple therapy with esomeprazole 20mg BD, amoxicillin 1000mg BD, levofloxacin 500mg OD for 14-days will be given. Yes - There is a plan to make this available What will be shared: statistical analysis, results and conclusions of the study will be available online When: After completion of data collection. approximately by March 2023 To whom: Data will be kept safe with the principal investigator Conditions: Through data sheets Where to obtain: drfaru11@gmail.com How to obtain: Contact the principal Invetigator Comments: not applicable
public Farzana Waqar
House no 357 street 47A Phase 2 Margalla Town Islamabad
Islamabad Pakistan 44000 +92 51 4251022 drfaru11@gmail.com National University of Medical Sciences Rawalpindi scientific Farzana Waqar
House no 357 street 47A Phase 2 Margalla town Islamabad
Islamabad Pakistan 44000 +92 51 4251022 drfaru11@gmail.com NUMS Pakistan Positive stool antigen test for h-pylori,endoscopic histopathological evidence of h-pylori. Age 18 years and above Both male and female patients presented with symptoms of dyspeps 18 years 80 years Both Patient with history of drug allergy to either Pantoprazole, Vonoprazan Vonoprazan, penicillin’s or clarithromycin , Previous h-pylori eradication therapy, Pregnant and breast-feeding mothers, Patient with serious CVS, liver, renal, pulmonary disorders or acute malignancy, ,History of gastric malignancy or surgery, History of drug abuse. History of using anti-biotics that affect h-pylori with in 4 weeks B96.81 Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere Treatment - Drugs Treatment - Drugs Intervention group: group 2 is the interventional group to which 7-days vonoprazan based triple therapy, new drug regimen, vonoprazn 20mg BD, amoxicillin 1000mg BD, levofloxacin 500mg OD for 7-days will be given. Control group: Control group 1 in which 14-days esomeprazole based conventional triple therapy with esomeprazole 20mg BD, amoxicillin 1000mg BD, levofloxacin 500mg OD for 14-days will be given Conversion of stool antigen from positive to negative. Timepoint: After 4 weeks after the therapy. Method of measurement: Lab investigation. clinical assessment for symptoms improvement and side effects. Improvement of clinical symptoms, side effects ,drug compliance,tolerability. Timepoint: 2 and 4 weeks after intervention. Method of measurement: Through telephone and after 4 weeks at hospital OPD. National university of Medical Sciences Rawalpindi Approved 2022-11-22 Institutional review committee The mall parking lot,abid majeed road Rawalpindi Punjab Rawalpindi Punjab Pakistan