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IRCT20231227060546N1 IRCT 2024-01-30 Mashhad University of Medical Sciences patients with Functional Dyspepsia Comparative Study of the Efficacy of Helicobacter pylori Eradication Therapy and Helicobcide in patients with Functional Dyspepsia: A Randomized Clinical Trial 2024-02-20 anticipated 112 Complete https://irct.ir/trial/74972 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is block-based and the randomization unit is a block of four. The randomization tool and random sequence construction is done using the random number table and through the website www.randomization.com. In this study, we have two groups (indicated by the letters A and B), Blinding description: Considering that this study will be designed in a double-blind manner, the patients, caregivers, and clinical evaluators are unaware of the contents of packages A and B. The drug and placebo will be produced in the faculty of pharmacology, and for proper blinding, the drug and the placebo will be completely similar in terms of color, size, and smell, and apart from the pharmacist, none of the participants and researchers will have access to them until the end of the study. They will not be aware. 3 Dyspepsia (without ulcers) with positive Helicobacter pylori infection. Intervention 1: Intervention group: Taking Holcobside medicine (capsules containing 400 mg of ginger) once a day after lunch for one month. Intervention 2: Control group: Treatment with four drugs including metronidazole, tetracycline, bismuth, a proton pump inhibitor such as pantoprazole, each once a day after lunch for a month. 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 There is no further information
public Maryam Anvary
Internal Medicine Ward, Emam Reza Hospital, Emam Reza Sq.
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3854 3031 maryamanvary299@gmail.com Mashhad University of Medical Sciences scientific Maryam Anvary
Internal Medicine Ward, Emam Reza Hospital, Emam Reza Sq.
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3854 3031 maryamanvary299@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 45 years Consent to enter the study and take the prescribed drugs Patients with functional dyspepsia (without ulcers) The patient with Helicobacter pylori infection was Ag based on stool exam Not receiving four-drug treatment and not receiving antibiotics from the last two months until entering this study 18 years 45 years Male Uncompensated heart failure Uncompensated liver failure Dialysis patients Patients with hematologic Malignancies Patients treated with anticonvulsants History of allergy to ginger pregnancy History of allergic disorders K30 Functional dyspepsia Treatment - Drugs Placebo Intervention group: Taking Holcobside medicine (capsules containing 400 mg of ginger) once a day after lunch for one month Control group: Treatment with four drugs including metronidazole, tetracycline, bismuth, a proton pump inhibitor such as pantoprazole, each once a day after lunch for a month Eradication of Helicobacter pylori by antigen examination. Timepoint: A month afte3r completion of treatment. Method of measurement: Detection of Helicobacter pylori antigen in stool samples. Mashhad University of Medical Sciences Approved 2023-05-30 Ethics Committee of Mashhad University of Medical Sciences Daneshgah Ave. Mashhad Razavi Khorasan Iran (Islamic Republic of)