<?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>IRCT201103264317N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-05-15</date_registration>
      <primary_sponsor>Sbmu Pharmaceutical Sciences Research Center</primary_sponsor>
      <public_title>Effects of Licorice on Relief and Recurrence of Menopausal Hot Flashes</public_title>
      <acronym>Hot Flashes</acronym>
      <scientific_title>Effects of Licorice on Relief and Recurrence of Menopausal Hot Flashes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4582</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Single, Purpose: Treatment, Other design features: Age, duration of amenorrhea as well as onset, frequency and severity of hot flash as intervening variables were matched.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hot flash.</hc_freetext>
      <i_freetext>Intervention 1: Licorice  capsules contained 330mg licorice root abstract.The subjects took them for 8 weeks 3 times a day (morning, noon and night). Intervention 2: Placebo capsules had 330mg starch with the same shape. The subjects in control group  took them for 8 weeks 3 times a day (morning, noon and night).</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>Fatemeh Nahidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Women’s affairs Office, Shaheed Beheshti University of Medical Sciences and Health Services, Beside Taleghani Hospital, Evin, Tabnak St., Shaheed Chamran Avenue, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2243 9912</telephone>
        <email>nahidifateme@yahoo.com</email>
        <affiliation>Shaheed Beheshti University of Medical Sciences and Health Services</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Nahidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Women’s affairs Office, Shaheed Beheshti University of Medical Sciences and Health Services, Beside Taleghani Hospital, Evin, Tabnak St., Shaheed Chamran Avenue, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 4421 8052</telephone>
        <email>nahidifateme@yahoo.com , nahidi@sbmu.ac.ir</email>
        <affiliation>Shaheed Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: The subjects were between 45-60, had body mass index (BMI) under 29, experienced amenorrhea at least 1 year or at most 3 years, suffered from hot flash and used no drug or hormone to relieve it. In addition, they had no known disease in their medical records, didn’t take antidepressants or sedatives, were married or lost their husbands not sooner than 1 year, experienced no stressful event (e.g. death of close family members, divorce etc.) in the past 6 months, were not vegetarian or had no allergy to herbs as well as no history of estrogenic cancers in themselves or their close relatives.&#13;
Exclusion criteria: The subjects were decided to use drug or hormone and  herbals medicin  to relieve hot flashes.</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N95.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Menopausal and female climacteric states</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Licorice  capsules contained 330mg licorice root abstract.The subjects took them for 8 weeks 3 times a day (morning, noon and night).</i_keyword>
      <i_keyword>Placebo capsules had 330mg starch with the same shape. The subjects in control group  took them for 8 weeks 3 times a day (morning, noon and night).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Relief. Timepoint: Weekly. Method of measurement: Information form.</prim_outcome>
      <prim_outcome>Recurrence. Timepoint: Weekly. Method of measurement: Information form.</prim_outcome>
      <prim_outcome>Frequency of hot flash. Timepoint: At the end of each week, for 2 weeks before the intervention , for 8 weeks of the intervention for 4 weeks of followed up stage. Method of measurement: Information form.</prim_outcome>
      <prim_outcome>Severity of hot flash. Timepoint: At the end of each week, for 2 weeks before the intervention , for 8 weeks of the intervention for 4 weeks of followed up stage. Method of measurement: Information form.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Daily food intake. Timepoint: At the end of each week. Method of measurement: Information form.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: Weekly. Method of measurement: Sphygmomanometer( instrument for measuring blood pressure).</sec_outcome>
      <sec_outcome>Weight. Timepoint: Weekly. Method of measurement: Scale.</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>Sbmu Pharmaceutical Sciences Research Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-01-21</approval_date>
        <contact_name>Shaheed Beheshti University of Medical Sciences and Health Services</contact_name>
        <contact_address>Shaheed Beheshti University of Medical Sciences and Health Services, Beside Taleghani Hospital, Evin, Tabnak St., Shaheed Chamran Avenue, Tehran, Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
