<?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>IRCT20190603043807N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-10</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Survey the effect of Elaeagnus Angustifolia  supplementation on the symptoms of primary dysmenorrhea in female students of Ahvaz Jundishapur university</public_title>
      <acronym></acronym>
      <scientific_title>Survey the effect of Elaeagnus Angustifolia  supplementation on the symptoms of primary dysmenorrhea in female students of Ahvaz Jundishapur university</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40141</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The block randomization method is divided into two groups of receiving placebo and placebo based on 6 blocks of individuals, Blinding description: Both participants in the intervention and control groups and the clinical caregivers associated with the patients were unaware of the type of received sorghum and the received sorghum and corn starch syrups were similar in appearance. The carcasses will be supplemented with placebo and placebo labeled A and B, and before starting the study, the carcasses will be coded by a person other than the researcher as group A containing powdered powder and group B containing corn starch to Lack of researcher information on the type of capsules received by each group.</study_design>
      <phase>3</phase>
      <hc_freetext>primary dysmenorrhea.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group receiving sachet 15 g. Each participant is monitored over 3 periods. During the first period (menstrual cycle), participants record the severity of dysmenorrhea and its symptoms without any intervention. During the second and third menstrual cycles (for 2 months) they will receive a 15 gram sachet daily. Then, the severity of pain and bleeding are assessed. Demographic characteristics including age, height, weight, waist circumference, girth, physical activity level (PAL) are measured by the Metabolic Equivalent Physical Activity Questionnaire (MET), The Higg chart will assess the visual acuity questionnaire (VAS) to measure the severity and duration of bleeding. Intervention 2: Control group: The group receiving sachets containing 15 grams of corn starch. Each participant is monitored over 3 periods. During the first period (menstrual cycle), participants record the severity of dysmenorrhea and its symptoms without any intervention. During the second and third menstrual cycles (for 2 months) they will receive 15 grams of corn starch daily. They are then assessed for severity of pain and bleeding. Questionnaires on demographic characteristics including age, height, weight, waist circumference, girth, physical activity level (PAL) by Metabolic Physical Activity Questionnaire (MET), Higg chart for severity and bleeding period, pain assessment questionnaire The vas will be reviewed.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marzie Zilae</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Blvd</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15794-61357</zip>
        <telephone>+98 61 3336 2414</telephone>
        <email>Marziezilae67@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marzie Zilae</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Blvd</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15794-61357</zip>
        <telephone>+98 61 3336 2414</telephone>
        <email>Marziezilae67@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Single;
Age 18-26 years;
Literacy;
Having regular menstrual period between 26-30 days
Premenstrual syncope several hours ago;
Menstrual pain less than 3 days
primary menstrual pain in recent years
Moderate to severe dysmenorrhea according to visual analogue scale (VAS)
body mass index (BMI) = 18.5-24.9 kg / m2;
duration of menstrual bleeding more than 7 days;
No more than 14 healthbars consumed
no known medical illness
A special diet such as weight loss
obesity
No vegetarianism or water treatment
no tobacco or alcohol use
no regular exercise</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>26 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Use of oral contraceptives or other steroid hormones
so any genital tract disease,
a history of any problems or kidney stones,
any physical mental illness has been diagnosed</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N94.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Primary dysmenorrhea</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group receiving sachet 15 g. Each participant is monitored over 3 periods. During the first period (menstrual cycle), participants record the severity of dysmenorrhea and its symptoms without any intervention. During the second and third menstrual cycles (for 2 months) they will receive a 15 gram sachet daily. Then, the severity of pain and bleeding are assessed. Demographic characteristics including age, height, weight, waist circumference, girth, physical activity level (PAL) are measured by the Metabolic Equivalent Physical Activity Questionnaire (MET), The Higg chart will assess the visual acuity questionnaire (VAS) to measure the severity and duration of bleeding.</i_keyword>
      <i_keyword>Control group: The group receiving sachets containing 15 grams of corn starch. Each participant is monitored over 3 periods. During the first period (menstrual cycle), participants record the severity of dysmenorrhea and its symptoms without any intervention. During the second and third menstrual cycles (for 2 months) they will receive 15 grams of corn starch daily. They are then assessed for severity of pain and bleeding. Questionnaires on demographic characteristics including age, height, weight, waist circumference, girth, physical activity level (PAL) by Metabolic Physical Activity Questionnaire (MET), Higg chart for severity and bleeding period, pain assessment questionnaire The vas will be reviewed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intensity of pain. Timepoint: Before the beginning of intervention -  the first  and the second month after the intervention. Method of measurement: VISUAL ANALOG SCALE.</prim_outcome>
      <prim_outcome>Duration of pain. Timepoint: Before the beginning of intervention -  the first  and the second month after the intervention. Method of measurement: Table of Specifications of Control and Tracking Cycles.</prim_outcome>
      <prim_outcome>Duration of bleeding. Timepoint: Before the beginning of intervention -  the first  and the second month after the intervention. Method of measurement: Higam chart.</prim_outcome>
      <prim_outcome>The severity of the bleeding. Timepoint: Before the beginning of intervention -  the first  and the second month after the intervention. Method of measurement: Higam chart.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Body Mass Index. Timepoint: Before the intervention, the first month and the second after the intervention. Method of measurement: Weight (kg) to square (m).</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>Vice chancellor for research, University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-18</approval_date>
        <contact_name>Ethics committee of Ahvaz University of Medical Sciences</contact_name>
        <contact_address>GolestanBlv,  Jundishapur University of Medical Sciences ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
