<?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>IRCT2016070428780N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-02-08</date_registration>
      <primary_sponsor>Vice Chancellor for Research and Technology Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>Treatment of Vaginal Infections</public_title>
      <acronym>-</acronym>
      <scientific_title>Clinical Effects of Chlorhexidine Vaginal Gel in the Treatment of Vaginal Infections</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-06-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>102</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23252</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: -.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Vaginal Infection.</hc_freetext>
      <i_freetext>Intervention 1: The Third Group Included Patients with Concurrency both Vaginitis. For 5 days, one day in between , Clotrimazole Vaginal with Metronidazole or Chlorhexidine Vaginal Gel is Prescribed. In order to better Evaluate the Therapeutic Effects and Potential Drug side Effects, two and three weeks after Treatment, one day  Patients refer to Hospital  for Visited again. Intervention 2: The Second Group Included Patients are Bacterial Vaginosis. For 5 days, one day in Between , Metronidazole Vaginal Cream or Chlorhexidine Vaginal Gel is Prescribed. In order to better evaluate the therapeutic effects and Potential Drug side Effects, two and three weeks after Treatment, one day  Patients refer to Hospital  for Visited again. Intervention 3: The First Group Included Patients with Vaginal Candidiasis. For 5 days, one day in between , Clotrimazole Vaginal Cream or Vaginal Gel Chlorhexidine is prescribed. In order to better evaluate the Therapeutic effects and Potential drug side Effects, two and three weeks after Treatment, one day  patients refer to Hospital  for Visited again.</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 Somaye Parsa</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kermanshah University of Medical Sciences Sorkhe Lyzheh- Imam Reza Teaching hospital-Office of Women's Education</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714869914</zip>
        <telephone>+98 83 3427 4618</telephone>
        <email>civil3285@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Maryam Zangene</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kermanshah University of  Medical Science- Sorkhe Lyzheh- Imam Reza  Teaching Hospital-Office Of Women's Education</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714415333</zip>
        <telephone>+98 83 3427 6301</telephone>
        <email>mzangene.59710@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>List Inclusion and Exclusion criteria separately(Inclusion Criteria: Women Before the age of Menopause and Non-pregnant; with Abnormal Vaginal Discharge; Without  Underlying Disease Such as Diabetes; Immunosuppressive Drugs; Cervicitis  and  Excluded criteria:  There are no Specific Criteria)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N74*</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female pelvic inflammatory disorders in diseases classified elsewhere</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The Third Group Included Patients with Concurrency both Vaginitis. For 5 days, one day in between , Clotrimazole Vaginal with Metronidazole or Chlorhexidine Vaginal Gel is Prescribed. In order to better Evaluate the Therapeutic Effects and Potential Drug side Effects, two and three weeks after Treatment, one day  Patients refer to Hospital  for Visited again.</i_keyword>
      <i_keyword>The Second Group Included Patients are Bacterial Vaginosis. For 5 days, one day in Between , Metronidazole Vaginal Cream or Chlorhexidine Vaginal Gel is Prescribed. In order to better evaluate the therapeutic effects and Potential Drug side Effects, two and three weeks after Treatment, one day  Patients refer to Hospital  for Visited again.</i_keyword>
      <i_keyword>The First Group Included Patients with Vaginal Candidiasis. For 5 days, one day in between , Clotrimazole Vaginal Cream or Vaginal Gel Chlorhexidine is prescribed. In order to better evaluate the Therapeutic effects and Potential drug side Effects, two and three weeks after Treatment, one day  patients refer to Hospital  for Visited again.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Vaginitis. Timepoint: A week after Intervention. Method of measurement: Physical Examination and the Patient's Scoring.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Vaginal Irritation. Timepoint: Within a Week. Method of measurement: Question.</sec_outcome>
      <sec_outcome>Nausa. Timepoint: Within a Week. Method of measurement: Question.</sec_outcome>
      <sec_outcome>Vomiting. Timepoint: Within a Week. Method of measurement: Question.</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 and Technology Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-06-25</approval_date>
        <contact_name>Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Kermanshah, Ave shahid beheshti. Building No. 2 Kermanshah  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
