<?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>IRCT2016090529710N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-09-30</date_registration>
      <primary_sponsor>Kashan University of Medical Scinces and Health Services</primary_sponsor>
      <public_title>Effect of oral and vaginal administration probiotic in treatment of women with vaginal candidiasis</public_title>
      <acronym></acronym>
      <scientific_title>Effect of oral and vaginal administration probiotic in treatment of women with vaginal candidiasis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-07-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23813</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done by simple method and using random numbers generated by computer software (Stat Trek software). In this method the computer selects random numbers. with consideration of numbers, the two groups are randomized, Blinding description: Placebo will be used to achieve participants,Care provider  and investigators will be masking. The researchers and patients will be concealed until the final analyses by a trained staff.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Vulvovaginal Candidiasis.</hc_freetext>
      <i_freetext>Intervention 1: Oral Fluconazol treatment with   Oral probiotic capsules containing Lactobacillus acidophilus,Lactobacillus plantarum,Lactobacillus fermentum, Lactobacillus gasseri 1×10 9 colony are known as lactofem for once a day for 27 days(4 weeks) plus Vaginal probiotic capsules containing  Lactobacillus acidophilus, Lactobacillus rhamnosus,   Lactobacillus gasseri, Lactobacillus plantarum 1×10 9colony are known as lacto Vage for once every night for 14days(4 weeks). Intervention 2: Oral Fluconazol treatment with Oral placebo for once a day for 27 days(4 weeks) plus Vaginal placebo for once every night for 14days(4 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>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 Undecided - It is not yet known if there will be a plan to make this available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehdi Nazeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5th of Qotb –e Ravandi Blvd. P.O.Box: 8715988141, Kashan, IRAN</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715988141</zip>
        <telephone>+98 31 5554 1112</telephone>
        <email>nazeri_me@kaums.ac.ir</email>
        <affiliation>Department of Medical Parasitology and Mycology, Medical faculty, kashan university of medical scien</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Nazeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghotbe Ravandi Boulevard, Kashan</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715988141</zip>
        <telephone>+98 31 5554 1112</telephone>
        <email>nazeri_me@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>married women aged 18-45 years old
none pregnant
absence of menstruation at the time of attendance
not using vaginal medications, antibiotics , immonosupressive drugs and exogenous hormones such as oral contraceptives since 2 weeks before starting the research; not having intercourse or using vaginal douche within the last 24hours
absence of any diagnose medical disease such as diabetis and other auto immune diseases, by asking the patient
not having intercourse or using vaginal douche within the last 24 hours
verification of vulvovaginal candidiasis resulted clinical symptoms and KOH positive smear and culture</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>allergic reactions to fluconazole, lactovag and lactofem
pregnancy during therapy
compulsion to use antibiotics or other anti fungal drugs.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B37.3</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>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Oral Fluconazol treatment with   Oral probiotic capsules containing Lactobacillus acidophilus,Lactobacillus plantarum,Lactobacillus fermentum, Lactobacillus gasseri 1×10 9 colony are known as lactofem for once a day for 27 days(4 weeks) plus Vaginal probiotic capsules containing  Lactobacillus acidophilus, Lactobacillus rhamnosus,   Lactobacillus gasseri, Lactobacillus plantarum 1×10 9colony are known as lacto Vage for once every night for 14days(4 weeks)</i_keyword>
      <i_keyword>Oral Fluconazol treatment with Oral placebo for once a day for 27 days(4 weeks) plus Vaginal placebo for once every night for 14days(4 weeks)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Vaginal candidiasis symptoms. Timepoint: 35-30 days after starting probiotic or placebo treatment. Method of measurement: questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Dirct smear and Culture. Timepoint: 30-30 days after starting treatment with fluconazole and probiotic or placebo. Method of measurement: culture and direct smear.</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>Kashan University of Medical Scinces and Health Services</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-07-10</approval_date>
        <contact_name>Kashan University of Medical Scinces and Health Services</contact_name>
        <contact_address>5th of Qotb –e Ravandi Blvd. P.O.Box: 8715988141, Kashan, IRAN kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
