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IRCT20131124015510N6 IRCT 2025-01-24 Mazandaran University of Medical Sciences Comparison of the efficacy quadreple therapy and triple therapy regimens on Helicobacter pylori eradication Comparison of the efficacy of 14- day high dose triple therapy regimen with 12-day concomitant quadreple therapy regimen on Helicobacter pylori eradication 2025-01-20 anticipated 240 Complete https://irct.ir/trial/81209 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, we use a Random Number Generator to extract 240 random numbers from one to 240. These 240 extracted numbers include 1 and 2, which are arranged randomly and then the first number of patients are included in the study Number 1 receives the standard regimen and number 2 receives the study regimen, Blinding description: Patients who include the the study would be blind. This means that the patient does not know whether she is receiving the 4-drug regimen or the high-dose 3-drug regimen. 3 Helicobacter Pylori Infection. Intervention 1: Intervention group: Patients receiving 14 days high-dose triple therapy of esomeprazole and amoxicillin & bismuth regimen for Helicobacter pylori eradication. Intervention 2: Control group: Patients receiving a 12-day four-drug regimen for Helicobacter pylori eradication. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is This decision will be made in consultation with project partners.
public Seyed Mohammad Valizadeh Toosi
Amir mazandarani
shvd Iran (Islamic Republic of) 4815658681 +98 11 3336 1341 seyedmohammadv@yahoo.com Mazandaran University of Medical Sciences scientific seyed mohammad valizadeh toosi
amir mazandarani
Sari Iran (Islamic Republic of) 4815658681 +98 11 3336 1341 seyedmohammadv@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria : ages between 18 and 80 years who have H. pylori positive and have endoscopic findings of gastric ulcer duodenal ulcer gastritis duodenitis histologic evidence of intestinal metaplasia. 18 years 80 years Both Pregnant or nursing women, those with a history of upper GI surgery major cardiac diseases major lung diseases major liver diseases history of previous H. pylori eradication regimen history of known side effects to the protocol drugs major renal diseases B96.81 Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere Treatment - Drugs Treatment - Drugs Intervention group: Patients receiving 14 days high-dose triple therapy of esomeprazole and amoxicillin & bismuth regimen for Helicobacter pylori eradication Control group: Patients receiving a 12-day four-drug regimen for Helicobacter pylori eradication Helicobacter pylori infection. Timepoint: Before the start of the Helicobacter pylori eradication regimen. Method of measurement: Through pathology before starting of Helicobacter pylori treatment regimen. Helicobacter pylori eradication. Timepoint: 8 weeks after end of HP eradication treatment. Method of measurement: Helicobacter pylori stool antigen test. Mazandaran University of Medical Sciences Approved 2025-01-06 Ethics Committee of Imam Khomeini Hospital Educational and Medical Center Amir mazandarani Sari Mazandaran Iran (Islamic Republic of)