The effect of the edible product prepared from mountain pistachio (Pistacia atlantica) on fatigue

The effect of the edible product prepared from mountain pistachio (Pistacia atlantica) on fatigue

The clinical trial with two intervention and control groups, in a parallel, randomized and three-blind manner, will be conducted on 80 volunteers with simple randomization.

This study will be clinical, randomized and three-way blind and will be conducted on qualified armed forces soldiers at Ayatollah Khatami barracks in Yazd with a sample size of approximately 80 people. 15 cc of traditional medicine product as well as placebo will be given daily to two intervention and control groups. The level of fatigue before and after the intervention will be measured with Smets Multidimensional Fatigue Measurement Questionnaire.

Inclusion criteria: All soldiers are serving in the same unit (in terms of job description). People should be in the age range of 18 to 26 years. Obtaining consent to enter the study and continue it. Ability to track people. Not taking medicine for the existing complaint two weeks before the start of the study. Exclusion criteria: Presence of acute or chronic illness (including diabetes, hypertension, hyperlipidemia, severe weight loss, and hypothyroidism) in soldiers based on data collected in the interview. History of any type of allergic reaction to pistachios, mountain pistachios, rose water or grape vinegar.

Intervention group: Edible product containing mountain pistachios: 15 cc of the syrup will be given to the study subjects daily for 15 days. Control group: 15 cc of placebo syrup will be given to the study subjects daily for 15 days.

Fatigue indicators

For randomization, we will use four block randomization method. For this purpose, we prepare four sheets of paper. On two sheets of paper we write the letters I meaning "Intervention" and on two sheets the letter P meaning "Placebo". We mix the sheets together and put them in the desk drawer. Upon the visit of each eligible patient, one of the sheets will be drawn randomly and based on whether the drawn sheet is I or P, they will be assigned to one of the two intervention or control groups. It should be noted that the drawn cards will not be returned to the table drawer until all four cards have been drawn. After randomly pulling out all four sheets, all the sheets will be returned to the drawer and the above procedure will be continued for the next four patients until the desired sample size (80 patients) is reached.

The drug and placebo will be prepared in similar containers by the respected pharmacist, and the smell of rose water and the combination of the taste of sugar and grape vinegar in both groups will prevent the blinding process from being disturbed. In this study, participants, researchers, clinical caregivers, outcome assessors and data analysts, as well as the safety and data monitoring committee, do not know which container is the drug and which is the placebo.

Except for the participant data file, other parts of the study potentially can be shared after de-identification.

The access period will start 6 months after the results are published.

Study information will be available only to researchers working in academic and scientific institutions.

The data can be used in order to improve the level of soldiers' health, especially in terms of mental health, subject to obtaining permission from the main researcher and the Army University of Medical Sciences.

Dr. Abolfazl Dehghanpour, Artesh University of Medical Sciences, Tehran - Fatemi West Street - Shahid Etemadzadeh Street. Postal code: 1411718541 Phone: +98 21 8609 6350 Email: jps@ajaums.ac.ir

6 months after the publication of the article resulting from the results in one of the ISI journals, the applicant can apply by sending his/her request via email (to A.dehghanpoor@ssu.ac.ir) and obtaining permission to receive the data.