<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20170423033605N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-28</date_registration>
      <primary_sponsor>Artesh University of Medical Sciences</primary_sponsor>
      <public_title>The effect of mountain pistachio (Pistacia atlantica) on sold fatigue</public_title>
      <acronym></acronym>
      <scientific_title>The effect of the edible product prepared from mountain pistachio (Pistacia atlantica) on fatigue</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65488</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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.</study_design>
      <phase>3</phase>
      <hc_freetext>Chronic Fatigue Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Edible product containing mountain pistachios: 15 cc of the syrup will be given to the study subjects daily for 15 days. The edible product in the form of syrup contains pistachios, rose water, grape vinegar and sugar. Intervention 2: Control group: Placebo: 15 cc of syrup will be given to the study subjects daily for 15 days. Placebo is a syrup containing sugar, rose water and grape vinegar.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Considering that this study is conducted on armed forces soldiers; The release of personal information is subject to the permission of the responsible military authorities.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abolfazl Dehghanpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imamshahr, Kargar Blvd., Farhang St., Alley 21, No. 12</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8917786888</zip>
        <telephone>+98 35 3522 1596</telephone>
        <email>adf442@yahoo.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abolfazl Dehghanpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imamshahr, Kargar Blvd., Farhang St., Alley 21, No. 12</address>
        <city>yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8917786888</zip>
        <telephone>+98 35 3522 1596</telephone>
        <email>adf442@yahoo.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All soldiers must be serving in the same unit (in terms of job descriptions)
Study subjects should be in the age range of 18 to 26 years
Obtaining consent to enter the study and continue it
Ability to track cases
Not taking drug for the existing complaint two weeks before the start of the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>26 years</agemax>
      <gender>Male</gender>
      <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</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R53.82</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic fatigue, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Edible product containing mountain pistachios: 15 cc of the syrup will be given to the study subjects daily for 15 days. The edible product in the form of syrup contains pistachios, rose water, grape vinegar and sugar.</i_keyword>
      <i_keyword>Control group: Placebo: 15 cc of syrup will be given to the study subjects daily for 15 days. Placebo is a syrup containing sugar, rose water and grape vinegar.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fatigue indicators. Timepoint: Fatigue measurement at the beginning of the study (before the start of the intervention) and 15 days after the start of the intervention. Method of measurement: Smets Multidimensional Fatigue Measurement Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Marital status. Timepoint: Before intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Complications of intervention. Timepoint: Two weeks after the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Temperament. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Mojahedi temperament questionnaire.</sec_outcome>
      <sec_outcome>Body mass index. Timepoint: Before intervention. Method of measurement: Mass (kilograms) divided by height squared (centimeters).</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Artesh University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-20</approval_date>
        <contact_name>The specialized committee of ethics in biomedical research of the University of Medical Sciences of</contact_name>
        <contact_address>Quds settlement (west) - between South Flamak and Zarafshan, Simai Iran St. - Ministry of Health, Treatment and Medical Education headquarters, block A, 13th floor Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
