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IRCT20250529065965N1 IRCT 2025-08-10 Kashan University of Medical Sciences The Efficacy of Bismuth in Helicobacter pylori Eradication The Efficacy of standard Sequential therapy with Bismuth in Helicobacter pylori Eradication 2024-04-08 anticipated 124 Complete https://irct.ir/trial/84098 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, the intervention group was coded with the letter A and the control group with the letter B, and then using the website www. sealedenvelope.com/simple-randomiser/v1/lists randomization list was prepared by selecting a sample size of 124 (two groups of 62) and permuted block randomization method (block size=4). Then, through the obtained randomization list, the subjects included in the study will be assigned to one of the two groups A or B. For example, suppose that in the first four blocks, the permutation method is ABBA, so the first and fourth samples will be assigned to group A and the second and third samples to group B and the same will continue until the last sample (124th person), Blinding description: The laboratory (Infection Eradication Evaluator) will be blinded to the study group. 3 Helicobacter pylori. Intervention 1: Intervention group: Standard treatment (omeprazole capsules produced by Iran Darou Company (20 mg every 12 hours), amoxicillin capsules 500 ml produced by Al-Hawi Pharmaceutical Company (1000 mg every 12 hours) in the first half of the treatment and omeprazole capsules produced by Iran Darou Company (20 mg every 12 hours) along with clarithromycin tablets produced by Tehran Shimi Company (500 mg every 12 hours) and tinidazole produced by Pars Darou Company (500 mg twice a day) for two weeks) + bismuth subcitrate 120 mg produced by Iran Darou Company, which is given to patients 2 tablets every 12 hours for 14 days. Intervention 2: Control group: Standard treatment includes omeprazole capsules produced by Iran Darou Company (20 mg every 12 hours), amoxicillin capsules 500 ml produced by Al-Hawi Pharmaceutical Company (1000 mg every 12 hours) in the first half of the treatment and omeprazole capsules produced by Iran Darou Company (20 mg every 12 hours) along with clarithromycin tablets produced by Tehran Shimi Company (500 mg every 12 hours) and tinidazole produced by Pars Darou Company (500 mg twice a day) for two weeks. 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 No more information available
public Fatemeh Sadeghi
Internal Medicine Department, Shahid Beheshti Hospital, Qotb-e Ravandi Boulevard, Kashan, Isfahan Province, Iran
Kashan Iran (Islamic Republic of) 8715973447 +98 31 5500 9999 Sadeghi.98.1f@gmail.com Kashan University of Medical Sciences scientific Abbas Arj
Internal Medicine Department, Shahid Beheshti Hospital, Qotb-e Ravandi Boulevard, Kashan, Isfahan Province, Iran
Kashan Iran (Islamic Republic of) 8715973447 +98 31 5500 9999 dr_arj@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Patients with functional dyspepsia or gastroduodenal ulcer who have an indication for eradicating Helicobacter pylori infection Confirmation of Helicobacter pylori infection through pathology results obtained from endoscopy or positive stool antigen test for Helicobacter pylori Minimum age 18 years 18 years no limit Both Previous eradication of Helicobacter pylori Use of antibiotics, PPIs, or chemotherapeutic agents within the 4 weeks prior to the study Patients with a history of gastrectomy or complicated peptic ulcer Pregnant and nursing women established.Patients with recompensated kidney and heart failure B98.0 Helicobacter pylori [H.pylori] Treatment - Drugs Treatment - Drugs Intervention group: Standard treatment (omeprazole capsules produced by Iran Darou Company (20 mg every 12 hours), amoxicillin capsules 500 ml produced by Al-Hawi Pharmaceutical Company (1000 mg every 12 hours) in the first half of the treatment and omeprazole capsules produced by Iran Darou Company (20 mg every 12 hours) along with clarithromycin tablets produced by Tehran Shimi Company (500 mg every 12 hours) and tinidazole produced by Pars Darou Company (500 mg twice a day) for two weeks) + bismuth subcitrate 120 mg produced by Iran Darou Company, which is given to patients 2 tablets every 12 hours for 14 days Control group: Standard treatment includes omeprazole capsules produced by Iran Darou Company (20 mg every 12 hours), amoxicillin capsules 500 ml produced by Al-Hawi Pharmaceutical Company (1000 mg every 12 hours) in the first half of the treatment and omeprazole capsules produced by Iran Darou Company (20 mg every 12 hours) along with clarithromycin tablets produced by Tehran Shimi Company (500 mg every 12 hours) and tinidazole produced by Pars Darou Company (500 mg twice a day) for two weeks. Eradication of Helicobacter pylori infection. Timepoint: After the end of the antibiotic treatment period, omeprazole treatment was continued for 4 weeks, and eradication of the infection was measured two weeks after omeprazole was discontinued. Method of measurement: Fecal antigen test. Side effects of treatment (bitter taste in the mouth, black stool, diarrhea, nausea, vomiting). Timepoint: After the treatment period. Method of measurement: Patient self-expression. Kashan University of Medical Sciences Approved 2023-10-01 Research Ethics Working Group/Committee, Faculty of Medicine and Dentistry, Kashan University of Med Ethics Committee, Vice-Chancellor for Research and Technology, Kashan University of Medical Sciences, Qotb-e Ravandi Boulevard, Kashan, Isfahan Province, Iran Kashan Isfehan Iran (Islamic Republic of)