Investigating the effectiveness of propolis as an adjuvant treatment for the eradication of Helicobacter pylori: Double-blind randomized controlled clinical trial

The effect of propolis on fecal Helicobacter pylori antigen and gastrointestinal symptoms in people with Helicobacter pylori infection.

Randomized clinical trial

This study will be conducted on patients with Helicobacter pylori infection referred to gastroenterology clinics of Urmia University of Medical Sciences. The study participants will be assigned to one of the two propolis or placebo groups using simple randomization. The intervention period will be 14 days. The subjects in the first group will receive 300 mg capsules containing propolis supplement (containing 50 mg propolis extract) 2 times a day, and the subjects in the second group will also receive the same amount of placebo capsules. Only the person responsible for packing the capsules containing propolis and placebo will know the relevant codes, and none of the researchers or patients will know the type of capsule that each person receives. All patients will receive standard Helicobacter pylori treatment which includes antibiotics. Participants will record their daily symptoms in a standardized questionnaire at baseline and at the second and fourth week after treatment. Helicobacter pylori antigen test will be used to evaluate the eradication of Helicobacter pylori in 2 weeks after completion of treatment.

Inclusion criteria: Patients aged 18-60 years old Helicobacter pylori infected patients Exclusion criteria: 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

Propolis and placebo

Anti-Helicobacter pylori antigen; Helicobacter pylori caused gastrointestinal complaints

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).

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.

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