<?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>IRCT2016011221412N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-05-21</date_registration>
      <primary_sponsor>Vice chancellor for research, Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>Effect of soybean supplementation and regular aerobic exercise in water on mental and physical symptoms of premenstrual syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Effect of soybean supplementation and regular aerobic exercise in water on mental and physical symptoms of premenstrual syndrome (PMS) female students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>92</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18771</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: For elimination of the possibility of any probable bias due to the knowledge of patients and assessing physicians about the type of treatment we will perform a double blind study. Soybean supplementation and Elaeagnus angustifolia powder as placebo will be encapsulated and for this reason patients and assessing physicians do not have any knowledge about the type of treatment. Randomization will be performed by the Randlist software and every patient will be entered into four intervention groups.</study_design>
      <phase>2</phase>
      <hc_freetext>Premenstrual Syndrome (PMS).</hc_freetext>
      <i_freetext>Intervention 1: Contrtol group:  patients with PMS (23 girls) which use placebo (one capsule filled with senjed powder for each day after lunch during 8 weeks). Intervention 2: Intervention group: single patients  with PMS during 8 weeks will use of one capsule of soybean supplementation each day. Intervention 3: Intervention group: single patients (23 girls) with PMS  and regular aquatic exercise during 8  weeks with 50-60% heart rate for 30 minutes. Intervention 4: Intervention group: patients with PMS (23 girls) and regular aquatic exercise with 50-60% heart rate for 30 minutes  will use of one capsule of soybean supplementation each day during 8 weeks.</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>Dr. Hamid Kalalian Moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahroud University of Medical Sciences, Haftom Tir Square</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>h.kalalian@shmu.ac.ir</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hamid Kalalian Moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahroud University of Medical Sciences, Haftom Tir Square</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>h.kalalian@shmu.ac.ir</email>
        <affiliation>Shahroud University of Medical Sciences, Haftom Tir Square</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: female gender between the ages 18-24 year old; Single; normal cycle (duration of cycle 21-35, bleeding 3-10 days); normal BMI with PMS. &#13;
Exclusion criteria: any history of disease such as hepatic; renal or respiratory cardiac; diabetes; or respiratory diseases, presence of secondary dysmenorrheal; sea food allergy; use of alcohol, smoking; presence of chronic diseases such as like migraine; use of any drug affecting PMS such as OCP or B6; stressful condition like death of family members.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>24 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>Placebo</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Contrtol group:  patients with PMS (23 girls) which use placebo (one capsule filled with senjed powder for each day after lunch during 8 weeks)</i_keyword>
      <i_keyword>Intervention group: single patients  with PMS during 8 weeks will use of one capsule of soybean supplementation each day</i_keyword>
      <i_keyword>Intervention group: single patients (23 girls) with PMS  and regular aquatic exercise during 8  weeks with 50-60% heart rate for 30 minutes</i_keyword>
      <i_keyword>Intervention group: patients with PMS (23 girls) and regular aquatic exercise with 50-60% heart rate for 30 minutes  will use of one capsule of soybean supplementation each day during 8 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Body fat percentage. Timepoint: 8 weeks after intervention. Method of measurement: Body analyzer.</prim_outcome>
      <prim_outcome>Waist-to-hip ratio (WHR). Timepoint: 8 weeks after intervention. Method of measurement: Body analyzer.</prim_outcome>
      <prim_outcome>Premenstrual syndrome (existing symptoms in PSST questionnaire). Timepoint: 8 weeks after intervention. Method of measurement: Body analyzer.</prim_outcome>
      <prim_outcome>Body water. Timepoint: 8 weeks after intervention. Method of measurement: Body analyzer.</prim_outcome>
      <prim_outcome>Fat-free mass index. Timepoint: 8 weeks after intervention. Method of measurement: Body analyzer.</prim_outcome>
      <prim_outcome>Body Mass Index. Timepoint: 8 weeks after intervention. Method of measurement: Body analyzer.</prim_outcome>
      <prim_outcome>Skeletal muscle mass. Timepoint: 8 weeks after intervention. Method of measurement: Body analyzer.</prim_outcome>
      <prim_outcome>Body Fat Mass. Timepoint: 8 weeks after intervention. Method of measurement: Body analyzer.</prim_outcome>
      <prim_outcome>Weight. Timepoint: 8 weeks after intervention. Method of measurement: Body analyzer.</prim_outcome>
      <prim_outcome>Basal Metabolic Rate (BMR). Timepoint: 8 weeks after intervention. Method of measurement: Body analyzer.</prim_outcome>
      <prim_outcome>Body impedance analysis. Timepoint: 8 weeks after intervention. Method of measurement: Body analyzer.</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>Vice chancellor for research, Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-06-11</approval_date>
        <contact_name>Ethics committee of Shahroud University of Medical Sciences</contact_name>
        <contact_address>Shahroud University of Medical Sciences, Haftom Tir Square Shahroud  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
