Efficacy and Safety of Pistacia atlantica Gum Essential Oil in Helicobacter pylori Eradication in Peptic Ulcer Disease: A Randomized Controlled Trial

Evaluation of Helicobacter pylori eradication rates in patients receiving Pistacia atlantica gum essential oil versus placebo

A phase III, double-blind, placebo-controlled, single-center, randomized clinical trial with two parallel arms, including 80 patients allocated in a 1:1 ratio to intervention (n=40) and control (n=40) groups.

Eligible patients attending the outpatient gastroenterology clinic at Imam Hossein hospital will be enrolled in the study and randomly assigned to either the intervention or control group using a random number table. After starting the Helicobacter pylori eradication regimen, patients will be followed up at multiple time points to monitor adherence to the treatment. The study will be conducted in a double-blind manner, with both patients and researchers unaware of group assignments.

Inclusion criteria: peptic ulcer along with positive Helicobacter pylori histopathology Exclusion criteria: renal or hepatic failure, pregnancy and breastfeeding

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 200 mcg twice daily for 2 weeks with an additional 6 weeks of omeprazole 20 mg twice daily. Control group: patients receiving the same standard eradicaion regimen along with Jiragastrin placebo twice daily for 2 weeks with an additional 6 weeks of omeprazole 20 mg twice daily. Jiragastrin capsules (Jiran Darou, Kurdistan) contain Pistachia atlantica gum essential oil and are standardized based on 200 mcg alpha-pinene as the active ingredient in each soft gelatin capsule.

Helicobacter pylori eradication rate (in percent)

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.

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.

All data may potentially be shared after de-identification of individual participants.

Starting in September 2028.

Only available for people working in academic institutions.

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.

Send email to: m_abbasi@sbmu.ac.ir.

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.