<?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>IRCT2017031133008N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-04-03</date_registration>
      <primary_sponsor>Vice chancellor for research of Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effect Of  Vaginal Cream  Glycyrrihiza  Glabra  On Improvement  Of Symptoms Of Fungal Vulvovaginitis</public_title>
      <acronym></acronym>
      <scientific_title>Effect Of  Vaginal Cream  Glycyrrihiza  Glabra  On Improvement  Of Symptoms Of Fungal Vulvovaginitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25571</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>candidal vulvovaginitis.</hc_freetext>
      <i_freetext>Intervention 1: vaginal cream licorice 50ml,one Applicator for7day. Intervention 2: vaginal cream clotrimazol 1%,one Applicator for7day.</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>Neda Dodange Balakhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Yasemi Rashid Street, Valiasr Street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8888 2885</telephone>
        <email>Neda.dod@gmail.com</email>
        <affiliation>Iran university of medical science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masomeh kheirkhah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Yasemi Rashid Street, Valiasr Street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8888 2886</telephone>
        <email>Shivakheirkhah1345@gmail.com</email>
        <affiliation>Iran university of medical science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Including criteria consisted of: Women at reproductive age of 15 to 45 years old ؛. married ؛. not being pregnant, menopause, and breast feeding ؛. having at least two symptoms of vaginal candidiasis in interview( observed and being confirmed by laboratory studies) ؛. Lack of chronic diseases such as disorders that weaken the immune system, blood pressure, and diabetes ؛. no use of Chemical and herbal antifungal drugs during the last two weeks ؛. not having other vaginal infection such as trichomonas vaginitis, bacterial and mixtures ؛. not using vaginal creams and suppositories during the 48 hours before starting of the study ؛. not participating in another  research study, simultaneously with this study ؛. lack of allergy to licorice ؛. lack of use of broad-spectrum antibiotics and corticosteroids during the last two weeks for any medical proposes .&#13;
Exclusion criteria consisted of: getting pregnant during the study ؛. allergy to licorice ؛. obligation to use of antibiotics for treatment of systemic infections other than vaginitis during the study ؛. Failure to adhere to the correct pattern of the treatment (forgetting the drug for more than one night).</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N77.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Candidiasis of vulva and vagina</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>vaginal cream licorice 50ml,one Applicator for7day</i_keyword>
      <i_keyword>vaginal cream clotrimazol 1%,one Applicator for7day</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Vaginal sores and lesions. Timepoint: 1,7,14day. Method of measurement: positive,negetive.</prim_outcome>
      <prim_outcome>Vaginal redness. Timepoint: 1,7,14day. Method of measurement: positive,negetive.</prim_outcome>
      <prim_outcome>Itching genitals. Timepoint: 1,7,14. Method of measurement: positive,negetive.</prim_outcome>
      <prim_outcome>Dysuria. Timepoint: 1,7,14 day. Method of measurement: positive,negetive.</prim_outcome>
      <prim_outcome>Cheesy white secretions. Timepoint: 1,7,14day. Method of measurement: positive,negetive.</prim_outcome>
      <prim_outcome>Dyspareunia. Timepoint: 1,7,14. Method of measurement: positive,negetive.</prim_outcome>
      <prim_outcome>Red vagina is with white discharge. Timepoint: 1,7,14day. Method of measurement: positive,negetive.</prim_outcome>
      <prim_outcome>Papulopustular damagesand. Timepoint: 1,7,14. Method of measurement: positive,negetive.</prim_outcome>
      <prim_outcome>Abnormal cervical. Timepoint: 1,7,14day. Method of measurement: positive,negetive.</prim_outcome>
      <prim_outcome>Laboratory evaluation. Timepoint: 1,7,14day. Method of measurement: positive,negetive.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Licorice sensitivity. Timepoint: 1,7,14. Method of measurement: positive,negetive.</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 of Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-02-22</approval_date>
        <contact_name>Iran University of Medical Sciences</contact_name>
        <contact_address>School of Nursing and Midwifery, Yasemi Rashid Street, Valiasr Street, Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
