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IRCT20121021011192N22 IRCT 2026-01-15 Shahid Beheshti University of Medical Sciences Wild Pistachio in Helicobacter pylori Eradication Efficacy and Safety of Pistacia atlantica Gum Essential Oil in Helicobacter pylori Eradication in Peptic Ulcer Disease: A Randomized Controlled Trial 2026-01-20 anticipated 80 Recruiting https://irct.ir/trial/86526 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, randomization will be performed using simple randomization with an allocation ratio of 1:1. The unit of randomization will be the individual, and each eligible patient will be considered as an independent unit in the randomization process. The random sequence will be generated using a random number table obtained from the website www.stattrek.com. Accordingly, a random, non-duplicate sequence of numbers 1 to 80 (based on the sample size) will be generated, considering the first 40 random numbers as group A and the second 40 random numbers as group B. Each patient will be assigned a number according to the order of entry and based on whether that number is in group A or B of the random sequence, will receive a medication labeled as such. Of note, the patients and investigators will not be informed of the assigned group to the patients (the intervention or control group) and labelling the medications as A or B will be carried out by an independent individual who is not involved in the study. To prevent allocation bias, allocation concealment will be ensured by keeping the randomization list with the independent individual and by restricting access of the researchers and outcome assessors to the allocation sequence until each patient is definitively enrolled in the study, Blinding description: Both the patients and investigators are blinded to the treatment allocation. The drug and placebo are identical in dosage form and packaging, and are labeled as A or B by a laboratory technician who is not involved in the study. 3 Condition 1: Peptic ulcer due to Helicobacter pylori infection. Condition 2: Positive histopathological test for Helicobacter pylori infection. Intervention 1: Intervention group: patients receiving omeprazole 20 mg twice daily, metronidazole 500 mg twice daily, amoxicillin 1 g twice daily, bismuth subcitrate 240 mg twice daily, and Jiragastrin (Jiran Darou - Sanandaj, Kurdistan) 200 mcg twice daily for 2 weeks with an additional 6 weeks of omeprazole 20 mg twice daily. Jiragastrin capsules contain Pistachia atlantica gum essential oil and are standardized based on 200 mcg alpha-pinene as the active ingredient in each soft gelatin capsule. Intervention 2: Control group: patients receiving omeprazole 20 mg twice daily, metronidazole 500 mg twice daily, amoxicillin 1 g twice daily, bismuth subcitrate 240 mg twice daily, and Jiragastrin placebo (Jiran Darou - Sanandaj, Kurdistan) twice daily for 2 weeks with an additional 6 weeks of omeprazole 20 mg twice daily. Yes - There is a plan to make this available What will be shared: All data may potentially be shared after de-identification of individual participants. When: Starting in September 2028. To whom: Only available for people working in academic institutions. Conditions: Researchers whose use of the data has been approved by an independent scientific committee should send an email to m_abbasi@sbmu.ac.ir, providing a written certificate for this purpose. Where to obtain: Send email to: m_abbasi@sbmu.ac.ir. How to obtain: Requests can be submitted for up to 6 months after publication of the related article. A response will be emailed to the requester within a maximum of one month. Comments:
public Mohammad Abbasinazari
No. 2660, School of Pharmacy, Niayesh junction, Valiasr street
Tehran Iran (Islamic Republic of) 1996835113 +98 21 8820 0083 m_abbasi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mohammad Abbasinazari
No. 2660, School of Pharmacy, Niayesh junction, Valiasr street
Tehran Iran (Islamic Republic of) 1996835113 +98 21 8820 0083 m_abbasi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Peptic ulcer confirmed through esophagogastroduodenoscopy (EGD) by a gastroenterology specialist Positive Helicobacter pylori histopathology 18 years 80 years Both Renal or hepatic failure Pregnancy and breastfeeding K27 B96.81 Peptic ulcer, site unspecified Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere Treatment - Drugs Placebo Intervention group: patients receiving omeprazole 20 mg twice daily, metronidazole 500 mg twice daily, amoxicillin 1 g twice daily, bismuth subcitrate 240 mg twice daily, and Jiragastrin (Jiran Darou - Sanandaj, Kurdistan) 200 mcg twice daily for 2 weeks with an additional 6 weeks of omeprazole 20 mg twice daily. Jiragastrin capsules contain Pistachia atlantica gum essential oil and are standardized based on 200 mcg alpha-pinene as the active ingredient in each soft gelatin capsule. Control group: patients receiving omeprazole 20 mg twice daily, metronidazole 500 mg twice daily, amoxicillin 1 g twice daily, bismuth subcitrate 240 mg twice daily, and Jiragastrin placebo (Jiran Darou - Sanandaj, Kurdistan) twice daily for 2 weeks with an additional 6 weeks of omeprazole 20 mg twice daily Helicobacter pylori eradication status. Timepoint: 2 weeks after completion of the 8-week medication regimen. Method of measurement: Helicobacter pylori stool antigen test. Occurrence rate of adverse drug reactions. Timepoint: At the end of week 2 of Helicobacter pylori eradication regimen. Method of measurement: Interview with the patients. Shahid Beheshti University of Medical Sciences Approved 2025-09-16 Ethics Committee of Pharmacy, Nursing, and Midwifery, Shahid Beheshti University of Medical Sciences No. 2660, School of Pharmacy, Niayesh junction, Valiasr street Tehran Tehran Iran (Islamic Republic of)