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IRCT20240622062210N1 IRCT 2024-08-01 Oroumia University of Medical Sciences propolis supplementation for the eradication of Helicobacter pylori Investigating the effectiveness of propolis as an adjuvant treatment for the eradication of Helicobacter pylori: Double-blind randomized controlled clinical trial 2024-07-22 anticipated 66 Complete https://irct.ir/trial/77579 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Allocation of subjects in each study groups (supplement and placebo) will be done by "Random Allocation Software" using the block random allocation method (blocks of 4), Blinding description: Allocation concealment will be used to reduce the selection bias error. All investigators, study participants, and the person responsible for data analysis will be blinded to the allocated groups. After obtaining the inclusion criteria, sealed envelopes with unique codes generated by Random Allocation Software will be allocated to the subjects. The codes along with groups A and B (supplement group and placebo indicators) will be generated at the beginning of the study by one of the collaborators of the project, who is not involved in clinical phases of the intervention and sampling. The investigators will remain unaware of the concept of codes and groups until the end of the study. Only A and B codes are inserted on the envelopes to identify two separate groups. After allocating patients in group A or B, the envelope is opened and the code inside the envelope that contains 4 numbers (for example 5372) with no concept and completely random will be labeled on the supplement box. Patients are not classified based on the A or B code and the numbers inside the envelope are the criteria for classification, and these codes are only used for labeling medicine and placebo boxes. 3 Patients with Helicobacter pylori infection. Intervention 1: Intervention group: Propolis/ Propolis group will receive 300 mg propolis capsules (containing 50 mg propolis extract) 2 times a day for 14 days. Intervention 2: Control group: placebo/ Placebo group will receive 300 mg capsules containing maltodextrin supplement twice a day for 14 days. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mohammadreza Pashaei
Clinical Research Institute, Imam Khomeini Educational and Medical Center, Modarres Blvd, Ershad St.
Urmia Iran (Islamic Republic of) 571478334 +98 44 3234 3477 dr.pashaei@yahoo.com Oroumia University of Medical Sciences scientific Mohammadreza Pashaei
Clinical Research Institute, Imam Khomeini Educational and Medical Center, Modarres Blvd, Ershad St.
Urmia Iran (Islamic Republic of) 571478334 +98 44 3234 3477 dr.pashaei@yahoo.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Patients aged 18-60 years old Helicobacter pylori infected patients 18 years 60 years Both Chronic diseases such as diabetes, CKD, Malignancy, gallbladder disorders, peptic ulcer and upper gastrointestinal surgery Consumption of propolis or other antioxidant supplements or herbal drugs over the past 3 months allergy to propolis K31.89 Other diseases of stomach and duodenum Treatment - Other Placebo Intervention group: Propolis/ Propolis group will receive 300 mg propolis capsules (containing 50 mg propolis extract) 2 times a day for 14 days. Control group: placebo/ Placebo group will receive 300 mg capsules containing maltodextrin supplement twice a day for 14 days. Fecal anti-Helicobacter pylori antigen. Timepoint: 14 days. Method of measurement: Measuring fecal anti-Helicobacter pylori antigen using PCR method. Helicobacter pylori caused gastrointestinal complaints. Timepoint: 14 days. Method of measurement: Helicobacter pylori caused gastrointestinal complaints questionnaire scale. Oroumia University of Medical Sciences Approved 2024-01-31 Ethics Committee in research of Imam Khomeini Medical Education Center, Urmia University of Medical Emam Khomeini hospital, Ershad ave, Urmia Urmia West Azarbaijan Iran (Islamic Republic of)