<?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>IRCT201106216854N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-07-19</date_registration>
      <primary_sponsor>Vice chancellor for research,Isfahan University of Medical Sciences</primary_sponsor>
      <public_title>determining the effect of magnesium,vitamin b6 and b6-magnesium combination on premenstrual syndrome in the affected persons that going to medical health centers of isfahan university</public_title>
      <acronym></acronym>
      <scientific_title>comparison of magnesium,vitamin b6 and b6-magnesium combination on premenstrual syndrome in the affected persons that going to medical health centers of isfahan university</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-04-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>170</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7294</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>premenstrual syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Magnesium &#13;
That consist of magnesium oxide (MgO)  powder that produced by MERK company and Drug faculty of Isfahan University  will make these productions in the shapes of 250 milligram magnesium tablet.the patients  will use one tablet daily. Intervention 2: vitamin B6:&#13;
Magnesium &#13;
That consist of pyridoxine  powder that produced by MERK company and Drug faculty of Isfahan University  will make these productions in the shapes of 40 milligram vitamin B6 tablet.the patients  will use one tablet daily. Intervention 3: placebo  &#13;
That consist of starch and Drug faculty of Isfahan University will make these productions in the shape  of tablet.the patients will use one tablet daily. Intervention 4: magnesium+vitamin b6  &#13;
       That consist of pyridoxine +magnesium oxide(MgO)powder that produced by MERK company and Drug faculty of Isfahan University will make these productions in the shapes of 40 milligram vitamin B6+250 milligram magnesium  tablet.the patients will use one tablet daily.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nahid Fathizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan , university of medical science, Hezarjarib street,Isfahan , Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 913 100 4312</telephone>
        <email>Fathizadeh@nm.mui.ac.ir</email>
        <affiliation>Isfahan university of medical science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Fathizade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan university of medical science, Hezarjarib street, Isfahan , Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 913 100 4312</telephone>
        <email>Fathizadeh@nm.mui.ac.ir</email>
        <affiliation>Isfahan University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criterial: The study population  will be  women of 45-15 referred to the selected health centers; who were affected by the PMS according to the criteria of American Psychiatry Association;  and also  met the inclusion criteria; being 45-15 years old; having regular menstrual cycle;  not being affected by depression or anxiety;  not having an acute or chronic  disease; not taking medicines or supplements; and not taking  regular exercise)&#13;
&#13;
exclusion criterial: will be pregnancy; willingness to use hormonal contraceptive methods or taking hormonal treatment; not taking the drug or not filling out the forms regularly; and unwillingness to continue the treatment</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></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>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Magnesium &#13;
That consist of magnesium oxide (MgO)  powder that produced by MERK company and Drug faculty of Isfahan University  will make these productions in the shapes of 250 milligram magnesium tablet.the patients  will use one tablet daily.</i_keyword>
      <i_keyword>vitamin B6:&#13;
Magnesium &#13;
That consist of pyridoxine  powder that produced by MERK company and Drug faculty of Isfahan University  will make these productions in the shapes of 40 milligram vitamin B6 tablet.the patients  will use one tablet daily.</i_keyword>
      <i_keyword>placebo  &#13;
That consist of starch and Drug faculty of Isfahan University will make these productions in the shape  of tablet.the patients will use one tablet daily.</i_keyword>
      <i_keyword>magnesium+vitamin b6  &#13;
       That consist of pyridoxine +magnesium oxide(MgO)powder that produced by MERK company and Drug faculty of Isfahan University will make these productions in the shapes of 40 milligram vitamin B6+250 milligram magnesium  tablet.the patients will use one tablet daily.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Premenstrual syndrome severity. Timepoint: 2 month before and 2 month after intervention. Method of measurement: questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>. Timepoint: . Method of measurement: .</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,Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-03-14</approval_date>
        <contact_name>Ethical Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan university of medical science, Hezarjarib street, Isfahan, Iran Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
