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IRCT20230503058065N1 IRCT 2024-01-22 Hamedan University of Medical Sciences Effect of propolis as an adjuvant treatment of Helicobacter pylori Evaluation of cyclodextrin and propolis complex as adjuvant treatment in patients with Helicobacter pylori 2024-02-04 anticipated 100 Complete https://irct.ir/trial/70184 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients will be divided into two treatment and control groups by block randomization. The randomization sequence will be in the form of 25 blocks of 4 in which the number of treatments is equal in each block. Blocks will be numbered from one to 25. In a simple random method, using a table of random numbers of blocks, the selection and sequence of treatments in the block will be the basis for assigning patients to treatments. The block randomization sequence is extracted from the following website. https://www.sealedenvelope.com/simple-randomiser/v1/lists, Blinding description: The patient, physician and research student who are responsible for collecting information will not know about the allocation of patients to treatment groups. 3 Helicobacter Pylori infection. Intervention group:. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the privacy of participants' data
public Aisa Mehri
No. 14, Yas Alley., Shokouh Street., Zamani Blvd
Hamedan Iran (Islamic Republic of) ۶۵۱۷۷۶۸۹۹۳ +98 81 3832 5546 Aisaamehrii@gmail.com Hamedan University of Medical Sciences scientific Shabnam Pourmoslemi
Pharmacy school, Hamadan medical University., Shahid Fahmide Blvd., Pazhohesh Square
Hamedan Iran (Islamic Republic of) 6517838678 +98 81 3252 0182 spourmoslemi@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with symptoms of dyspepsia Helicobacter pylori patients with a positive biopsy test 18 years 80 years Both People with duodenal gastrointestinal bleeding Pregnant women Breastfeeding women Patients with liver disorders Patients with renal failure Patients with heart failure Patients with a history of drug sensitivity to any of the studied drugs Patients who have previously been treated with Helicobacter pylori therapy Patients taking NSAIDs Patients who are taking corticosteroids Patients with a history of alcohol consumption Treatment - Drugs Intervention group: Improvement of digestive symptoms. Timepoint: 60 days after the start of the intervention. Method of measurement: Questionnaire and fecal antigen test. Helicobacter pylori eradication. Timepoint: 60 days after the start of the intervention. Method of measurement: Fecal antigen test. Hamedan University of Medical Sciences Approved 2023-04-29 Ethics committee of Hamedan University of Medical Sciences Hamedan University of Medical Sciences., Shahid Fahmide Blvd., Pazhohesh Square Hamedan Hamadan Iran (Islamic Republic of)