<?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>IRCT20190415043284N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-15</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Short Term Magnesium Preventation In Menstrually Related Migraine (MRM)</public_title>
      <acronym></acronym>
      <scientific_title>Studying effectiveness of Short Term oral Magnesium supplement Prophylaxis In Menstrually Related Migraine (MRM) in women in reproductive ages : A Randomized Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40885</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Participants assign to comparison groups (allocation sequence) with random allocation rule (a form of restricted randomisation procedures- after sample taking finished, we put magnesium and placebo papers, half and half number in a sortition container and bring them out randomly to make an allocation sequence.) and this allocation conceals by central randomization, Blinding description: Participants are unaware of who is receiving the real treatment and by means of a third party who collected data and bring them anonymous to assessor and and analyser blinding done.</study_design>
      <phase>3</phase>
      <hc_freetext>Menstrually Related Migraine (MRM).</hc_freetext>
      <i_freetext>Intervention group: each patient during 3 continuous menstrual cycles, taking one and half  (375 milligrams) of 250 miligrames magnesium oxide pills from Jalinous Pharmaceutical company daily and records headaches from 2 days before menstruation up to third day of mens.                                      Control group: each patient during 3 continuous menstrual cycles, taking one and half of placebo pills daily and records headaches from 2 days before menstruation up to third day of mens..</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Data about magnesium prophylaxis effects on menstrually related migraine headaches and its Side effects will share.

When:
at least 6 months after the date that results have been published.

To whom:
researchers who work for universities

Conditions:
To investigate weak points of this study to obtain and start a new and more useful work

Where to obtain:
Dr Ehsan Mohammadiani Nejad, neurology ward, Ahvaz Jundishapur university of medical sciences

How to obtain:
Deliver a request containing exact description of reasons for this request and make a list of the exact data which is needed, to the neurology group. this request will be checked as soon as possible and will be answered.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ehsan Mohammadiani Nejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Neurology ward, Golestan hospital, Farvardin Aven., Golestan Blv..</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33118-61357</zip>
        <telephone>+98 61 3374 3001</telephone>
        <email>p.yabande@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ehsan Mohammadiani Nejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Neurology ward, Golestan hospital, Farvardin Aven., Golestan Blv..</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33118-61357</zip>
        <telephone>+98 61 3374 3001</telephone>
        <email>p.yabande@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patients affected by menstrually related migraine according to 3rd edition of The International Classification of Headache Disorders
regular mense</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>chronic diarrhea
renal failure
nephrolithiasis
myasthenia gravis patients
anti hypertensive drug usage particularly calcium channel blocker users
diabetic patients who has insulin resistance state
pregnancy or planned pregnancy; ; menstrual migraine [14]
breast feeding women
non migraine headache
psychiatric illness according to DSM5 criteria
chronic systemic illness
dependence or abuse of drugs
intake of antidepressants, neuroleptics, minor or major tranquillizers, drugs used for the treatment of affective disorders (e.g. lithium, carbamazepine), antiepileptics
bradrychardia
anti coagulant and antiplatelet usage
pure menstrually migraine</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: each patient during 3 continuous menstrual cycles, taking one and half  (375 milligrams) of 250 miligrames magnesium oxide pills from Jalinous Pharmaceutical company daily and records headaches from 2 days before menstruation up to third day of mens.                                      Control group: each patient during 3 continuous menstrual cycles, taking one and half of placebo pills daily and records headaches from 2 days before menstruation up to third day of mens.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Headache attacks of menstrually related migraine. Timepoint: 4 questionnaires are filled: the first one at the sampling time and 3 others during 3 continuous menstrual cycles which the participant take pills. Method of measurement: questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Headache frequency, intensity, prolongation, amount of analgesic drugs and resulting palliation. Timepoint: 4 questionnaires are filled: the first one at the sampling time and 3 others during 3 continuous menstrual cycles which the participant take pills. Method of measurement: Each questionnaire contains a calendar with blanks to record: the exact date of menstruation starting date, headache days, headache intensity ( 1 to 10 scale), each headache attack prolongation (hours), number of analgesic pills to pain relief and resulting palliation (describes with excellent, good, intermediate and poor response).</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-05</approval_date>
        <contact_name>Ethics Committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>No. 3,Mahsa building, Alley 13, Khadem Sadeq Ave., Amir Kabir Blv., shiraz Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
