<?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>IRCT20091219002889N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-22</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effect of proplis vaginal gel on  trichomonas ectocervicitis in women referred to gynocologic clinics of Isfahan educational centers (2019).</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of proplis vaginal gel on trichomonas ectocervicitis.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>112</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44026</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A randomized controlled trial was carried out. One group of women who refer to clinics on the odd days. (Group A); the other group (Group B) refer to clinics on even-number days.</study_design>
      <phase>3</phase>
      <hc_freetext>exocervisitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: if this patient had the inclusion criteria, after submitting a description and obtaining informed consent, received a vaginal gel containing 7.5% of propolis extract that prepared by Salafchegan Pharmaceutical Company, with seven sterile packaged applicators and 14 metronidazole tablets 500 mg for used by their spouses. Patients used of vaginal gel( half of the applicator) every night before bed for seven nights. At the same time, the intervention group's spouses were treated with metronidazole 500 mg twice a day (every 12 hours) for seven days. Patients were advised to refrain from sexual intercourse during treatment and were given pamphlet-based health-nutrition recommendations. Intervention 2: Control group: if this patient had the inclusion criteria, after submitting a description and obtaining informed consent, receive 28 metronidazole 500 mg tablets for  treatment of themselves and their spouses.  The patients and their spouse used the drug twice a day (every 12 hours) for 7 days.  Patients were advised to refrain from sexual intercourse during treatment and were given pamphlet-based health-nutrition recommendations.</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>Seyedeh Shadi Taghavian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfhan</address>
        <city>Isfhan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>0098316689801</telephone>
        <email>Taqavianshadi@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahboube Valiani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Science, Hezar jereb Ave., azadi Blvd.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8199939438</zip>
        <telephone>+98 31 3792 2936</telephone>
        <email>valiani@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iranian race.
18-45 years old.
Be sexually active( married).
Had one sexual partner.
Not pregnant or lactating.
Not during menstruation period.
Positive wet smear in both groups.
A gynecologist confirmation of diagnosis.
Not having a history of drug allergy.
Not having a history of using antibiotics or vaginal drugs for ectocervicitis treatment in  last 1 months ago.
Not having a history of using hormonal and immunosuppressive drugs.
Not having a history of some diseases such as: chronic diabetes melitus, anemia, renal diseases, liver diseases, cardiovascular diseases and etc...
Not having a history of pelvic surgery.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Not interested in participating in the study.
Not referred for follow up visits.
Irregular used of drugs (two consecutive nights or three not-consecutive nights).
Used of other antibiotics.
Used of other palliative treatment.
Having sexual function without used of condom.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N77.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere</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>Intervention group: if this patient had the inclusion criteria, after submitting a description and obtaining informed consent, received a vaginal gel containing 7.5% of propolis extract that prepared by Salafchegan Pharmaceutical Company, with seven sterile packaged applicators and 14 metronidazole tablets 500 mg for used by their spouses. Patients used of vaginal gel( half of the applicator) every night before bed for seven nights. At the same time, the intervention group's spouses were treated with metronidazole 500 mg twice a day (every 12 hours) for seven days. Patients were advised to refrain from sexual intercourse during treatment and were given pamphlet-based health-nutrition recommendations.</i_keyword>
      <i_keyword>Control group: if this patient had the inclusion criteria, after submitting a description and obtaining informed consent, receive 28 metronidazole 500 mg tablets for  treatment of themselves and their spouses.  The patients and their spouse used the drug twice a day (every 12 hours) for 7 days.  Patients were advised to refrain from sexual intercourse during treatment and were given pamphlet-based health-nutrition recommendations.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Healing of trichomonas ectocervisiti. Timepoint: Pre intervention,1 and 2 weeks after intervention. Method of measurement: Self-made questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Healing of trichomonas ectocervisitis. Timepoint: Preintervention,1 and 2 weeks after intervention. Method of measurement: Self-made questionnaire.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-01</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Azadi Blvd., Hezar jerib Ave., milad dorm. Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
