<?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>IRCT20180423039389N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-16</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>Effect of nutrition education on Premensturation syndrom</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of effect of family centered and individual nutrition education on decrease bodily signs of premensturation syndrom in daughters 14-18 years old</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>342</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30940</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Prevention, Randomization description: Stage 1:At first, Qazvin is considered as 5 cluster. Then from each cluster, one high school is selected in simple  random that in average 5 high schools are selected.                                          
Stage 2:The  students who have moderate to severe premensturation syndrom are detected based on premenstruation questionnaire and exclusion and inclusion criteria.                        
Stage 3:  Card shuffling with coloured cards is used for putting  samples in three groups:  "students", "families" and "control".     
For randomize allocation, we provide 342 coloured cards such as yellow, blue and green that are separated in114 yellow cards, 114 green cards and 114 blue cards. Then after detecting students with premensturation syndrom (moderate to severe) one coloured card is given to her. After ending of allocate, students with yellow cards are ( intervention1), students with green cards are (intervention 2) and students with blue cards are Control group.
At last, 114 persons with yellow cards are in intervention group 1, 114 persons with green cards are in intervention group 2 and 114 persons with blue cards are in control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Premensturation Syndrom.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1 :The nutrition trainingto parents of students with premensturation syndrom. The nutrition training is based on hygiene ministry protocol at 4 weeks at 40 minutes. Intervention 2: Intervention group 2 : The nutrition training to students with premensturation syndrom. The nutrition training is based on hygiene ministry protocol at 4 weeks at 40 minutes with pamphelets. Intervention 3: Control group: The Students with Premenstruation Syndrom. This group wont have any Education.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There isn't more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Homa Javadi Aftabdari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.39; 8th Sadra Ave; West Mollasadra Blvd.</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3415835995</zip>
        <telephone>+98 28 3368 5521</telephone>
        <email>h.Javadiaftabdari@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Homa Javadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 39; 8th Sadra Ave; West Sadra Blvd.</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3415835995</zip>
        <telephone>+98 28 3368 5521</telephone>
        <email>h.Javadiaftabdari@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Have premensturation syndrom, based on premenstruation questionare.
Have regular and natural menstruation.
Be single.
Have 14-18 years old.
Live in Qazvin.
Be a student in one of schools in Qazvin.</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>18 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Have diseases.
Take Supplements.
History of cancer in family
Have stress on three month ago such as; death of relatives, marriage and operation.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N94.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Premenstrual tension syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1 :The nutrition trainingto parents of students with premensturation syndrom. The nutrition training is based on hygiene ministry protocol at 4 weeks at 40 minutes.</i_keyword>
      <i_keyword>Intervention group 2 : The nutrition training to students with premensturation syndrom. The nutrition training is based on hygiene ministry protocol at 4 weeks at 40 minutes with pamphelets.</i_keyword>
      <i_keyword>Control group: The Students with Premenstruation Syndrom. This group wont have any Education.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bodily signs mark of premenstruation syndrom in premenstruation syndrom questionnaire. Timepoint: Comparison of bodily signs of premenstruation syndrome before Intervention and 30 days after Intervention. Method of measurement: Premenstruation syndrom  questionnaire.</prim_outcome>
      <prim_outcome>Nurishment score based on recall nurishment  questionnaire. Timepoint: Comparison recall nurishment before Intervention and 30 days after Intervention. Method of measurement: Recall 24 hours questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-20</approval_date>
        <contact_name>Ethics committee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Qazvin university of medical sciences; Bahonar Blvd, Qazvin Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
