<?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>IRCT20210627051723N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-03</date_registration>
      <primary_sponsor>The University of Tehran</primary_sponsor>
      <public_title>The effect of combined exercise and L-arginine on adropine, VEGFR-2 and adhesive molecules in hypertensive postmenopausal women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of combined training and L-arginine ingestion on the serum levels of Adropin, VEGFR-2 and intercellular and vascular adhesion molecules in postmenopausal hypertensive women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57156</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Prevention, Randomization description: The subjects 'names are written on separate sheets of paper and placed in a container, then the subjects' names are randomly taken out and placed in the intervention or placebo group. The first 30 names are placed in the intervention group and the rest in the placebo gro, Blinding description: In order to eliminate the error caused by the awareness of the participants and the researcher Study on the type of treatment received and its possible impact on the research outcomeWe do it blindly in two directions.Because the placebo and L-arginine supplement are placed inside the capsule in exactly the same way, participants and researchers are not aware of the type of supplement they receive.</study_design>
      <phase>3</phase>
      <hc_freetext>Hypertension.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: L-arginine supplement group (L-arginine supplement daily and at a dose of 6 grams (three servings of 2 grams.). Intervention 2: Combined exercises will be performed for 8 weeks and three sessions per week. First, resistance training and a few minutes later, endurance training will be performe.). Intervention 3: Intervention group: Combined training group + L-arginine supplement (combined training will be performed for 8 weeks and three sessions per week. First, resistance training and a few minutes later, endurance training.At the same time, L-arginine supplement is taken daily and in the amount of 6 grams (three meals of 2 grams) every day.). Intervention 4: Control group:Placebo group (not participating in exercise and taking placebo. For 8 weeks, taking L-arginine-like capsules with white flour content (placebo) in the morning, evening and night, made by Darogostar company, in addition to daily activities of life.).</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 There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nourbakhsh Rozita</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 2/1, Shabnam Alley, Mahan Blvd,Jahanshahr</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3146685543</zip>
        <telephone>+98 21 3441 6041</telephone>
        <email>rozita.phd.1355@gmail.com</email>
        <affiliation>The University of Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ravasi Ali Asghr</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>In front of the university dormitory, Amirabad, North Kargar Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3146685543</zip>
        <telephone>+98 21 3441 6041</telephone>
        <email>rozita.phd.1355@gmail.com</email>
        <affiliation>The University of Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women 50 to 60 years old with menopause confirmed by a doctor
Confirmation of hypertension
No other cardiovascular diseases
Not participating in regular physical activity in the past year</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having type 2 diabetes
Restrictions on physical activity
Drug or alcohol addiction</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Essential (primary) hypertension</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: L-arginine supplement group (L-arginine supplement daily and at a dose of 6 grams (three servings of 2 grams.)</i_keyword>
      <i_keyword>Combined exercises will be performed for 8 weeks and three sessions per week. First, resistance training and a few minutes later, endurance training will be performe.)</i_keyword>
      <i_keyword>Intervention group: Combined training group + L-arginine supplement (combined training will be performed for 8 weeks and three sessions per week. First, resistance training and a few minutes later, endurance training.At the same time, L-arginine supplement is taken daily and in the amount of 6 grams (three meals of 2 grams) every day.)</i_keyword>
      <i_keyword>Control group:Placebo group (not participating in exercise and taking placebo. For 8 weeks, taking L-arginine-like capsules with white flour content (placebo) in the morning, evening and night, made by Darogostar company, in addition to daily activities of life.)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Adropin. Timepoint: First, the end of the study. Method of measurement: Kit Elisa.</prim_outcome>
      <prim_outcome>VEGFR-2. Timepoint: First, the end of the study. Method of measurement: Kit Elisa.</prim_outcome>
      <prim_outcome>ICAM-1. Timepoint: First, the end of the study. Method of measurement: Kit Elisa.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Systolic blood pressure. Timepoint: First,the end of the study. Method of measurement: Mercury blood pressure monitor.</sec_outcome>
      <sec_outcome>Diastolic blood pressure. Timepoint: First,the end of the study. Method of measurement: Mercury blood pressure monitor.</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>The University of Tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-03-14</approval_date>
        <contact_name>Ethics Committee of the Faculty of Physical Education and Sports Sciences, University of Tehran</contact_name>
        <contact_address>Thirteenth floor, Block A, Central headquarters of the Ministry of Health, Qads town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
