<?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>IRCT20181218042038N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-15</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of pms50 supplement on the psychological symptoms of   premenstrual syndrom</public_title>
      <acronym></acronym>
      <scientific_title>The effect of pms50 supplement on the psychological symptoms of girls with premenstrual syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36109</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple (assigning a person to a particular group completely randomly) through dice throwing, Blinding description: The type of blindness in this study will be double blind. Before starting the study, by dicing throwing by someone other than the researcher, the subjects are in the intervention group and the control group and the supplementary delivery to the patients is also performed by an individual other than the investigator. The study of patients and researcher who plays the role of collecting and analyzing data is kept blind.</study_design>
      <phase>3</phase>
      <hc_freetext>Psychological symptoms of premenstrual syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Supplement pms50 containing vitamins B1, B2, B6, E, D3, magnesium oxide and Vitagnus extract, two daily pills (one morning and one night) from one week before menstruation to the end of menstruation for three consecutive menstrual cycles. Intervention 2: Control group: Placebo, starch, two daily pills (one morning and one night) from one week before menstruation to the end of menstruation for three consecutive menstrual cycles.</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>Fatemeh sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan highway</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+98 61 7333 8383</telephone>
        <email>sadeghi.f@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ahmad zare javid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan highway</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+98 61 7333 1783</telephone>
        <email>ahmaddjavid@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Unmarried
Premenstrual syndrome
Regular menstrual cycle
Age range 25-35
Weight range 55-65kg
Normal BMI ranging from18.5 to 24.9 kg/m2</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Being married
Pregnancy
Lactation
Irregular menstrual cycle
Age younger than 25 or over 35 years old
Weight below 55 or above 65kg
Use of psychological drugs
Unwillingness of the participant to continue the research</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>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Supplement pms50 containing vitamins B1, B2, B6, E, D3, magnesium oxide and Vitagnus extract, two daily pills (one morning and one night) from one week before menstruation to the end of menstruation for three consecutive menstrual cycles</i_keyword>
      <i_keyword>Control group: Placebo, starch, two daily pills (one morning and one night) from one week before menstruation to the end of menstruation for three consecutive menstrual cycles</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Restlessness score in the Rossignol &amp; Bonlander Questionnaire. Timepoint: The beginning and the end of the study. Method of measurement: Rossignol &amp; Bonlander Questionnaire.</prim_outcome>
      <prim_outcome>Depression score in the Russugnol and Bonlander questionnaire. Timepoint: The beginning and the end of the study. Method of measurement: Rossignol &amp; Bonlander Questionnaire.</prim_outcome>
      <prim_outcome>Anger Score in the Rossignol &amp; Bonlander Questionnaire. Timepoint: The beginning and the end of the study. Method of measurement: Rossignol &amp; Bonlander Questionnaire.</prim_outcome>
      <prim_outcome>Irritability score in the Russugnol and Bonlander questionnaire. Timepoint: The beginning and the end of the study. Method of measurement: Rossignol &amp; Bonlander Questionnaire.</prim_outcome>
      <prim_outcome>Anxiety score  in the Rossignol &amp; Bonlander Questionnaire. Timepoint: The beginning and the end of the study. Method of measurement: Rossignol &amp; Bonlander Questionnaire.</prim_outcome>
      <prim_outcome>Transient mood Score in the Rossignol &amp; Bonlander Questionnaire. Timepoint: The beginning and the end of the study. Method of measurement: Rossignol &amp; Bonlander Questionnaire.</prim_outcome>
      <prim_outcome>Feeling frustrated score in the Rossignol &amp; Bonlander Questionnaire. Timepoint: The beginning and the end of the study. Method of measurement: Rossignol &amp; Bonlander Questionnaire.</prim_outcome>
      <prim_outcome>Loneliness and isolation score in the Russugnol and Bonlander Questionnaire. Timepoint: The beginning and the end of the study. Method of measurement: Rossignol &amp; Bonlander Questionnaire.</prim_outcome>
      <prim_outcome>The score for the lack of attractiveness in the Russugnol and Bonlander questionnaire. Timepoint: The beginning and the end of the study. Method of measurement: Rossignol &amp; Bonlander Questionnaire.</prim_outcome>
      <prim_outcome>Increased or decreased appetite score in the Russugnol and Bonlander questionnaire. Timepoint: The beginning and the end of the study. Method of measurement: Rossignol &amp; Bonlander Questionnaire.</prim_outcome>
      <prim_outcome>Score the tendency to salty or sweet foods in the Russugnol and Bonlander questionnaire. Timepoint: The beginning and the end of the study. Method of measurement: Rossignol &amp; Bonlander 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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-20</approval_date>
        <contact_name>Ethics Committee of Ahwaz University of Medical Sciences</contact_name>
        <contact_address>Golestan highway Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
