<?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>IRCT20200720048145N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-07</date_registration>
      <primary_sponsor>Alborz University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effectiveness of black seed oil in the treatment of vulvovaginal mucositis</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effectiveness of topical application of special emulsion for epithelial tissue prepared with black seed oil in the treatment of vulvovaginal  mucositis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50505</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A form has been prepared for the physician to divide the samples into intervention and control groups, which has a table in which the number of samples in the two intervention groups and a control group based on confounding variables of age, sex, sex and anatomical anomalies It is located in three separate rows and after placing the first sample in the table, the other samples will be placed in the group with the lowest number of samples after summing the number of samples in the intervention and control groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Inflammation of the vulvovaginal mucosa.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients use topical spray made from black seed oil emulsion at a dose of 1% twice a day at a dose of 2 puffs for 7 days. Intervention 2: Intervention group:  Patients use topical spray made from emulsion of 1% vegetable oils for 7 days, 2 times a day at a dose of 2 puffs and antibiotics prescribed by a doctor for 7 days once a day. Intervention 3: Control group: Patients will be treated with antibiotics prescribed by a physician (single dose of metronidazole 250 mg in bacterial vaginitis and trichomoniasis and single dose of fluconazole 100 mg in candidal vaginitis).</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Reza Maghsoudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azimiyeh,EmamAli Hospital</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3154686695</zip>
        <telephone>+98 26 3252 7576</telephone>
        <email>dr.maghsoudi@abzums.ac.ir</email>
        <affiliation>Alborz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Reza Maghsoudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azimiyeh,EmamAli Hospital</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3154686695</zip>
        <telephone>+98 26 3252 7576</telephone>
        <email>dr.maghsoudi@abzums.ac.ir</email>
        <affiliation>Alborz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 15-60 years
Do not using  immunosuppressive drugs, antibiotics and topical creams and ointments during the last week
Do not be pregnant or breastfeeding
Normal Pap smear test</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Allergy to the drug prescribed to the patient
Failure to follow treatment regularly and as directed
Mandatory administration of antibiotics by another physician outside the scope of the present study
Having sex with multiple partners during treatment</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>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients use topical spray made from black seed oil emulsion at a dose of 1% twice a day at a dose of 2 puffs for 7 days</i_keyword>
      <i_keyword>Intervention group:  Patients use topical spray made from emulsion of 1% vegetable oils for 7 days, 2 times a day at a dose of 2 puffs and antibiotics prescribed by a doctor for 7 days once a day.</i_keyword>
      <i_keyword>Control group: Patients will be treated with antibiotics prescribed by a physician (single dose of metronidazole 250 mg in bacterial vaginitis and trichomoniasis and single dose of fluconazole 100 mg in candidal vaginitis)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Inflammation of the vagina. Timepoint: In two stages before the intervention and after the intervention. Method of measurement: Examination of the vagina.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Vaginal discharge. Timepoint: Before and 7 days after the start of the intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Vaginal itching. Timepoint: Before and 7 days after the start of the intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Bad smell of vaginal discharge. Timepoint: Before and 7 days after the start of the intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Vaginal burning. Timepoint: Before and 7 days after the start of the intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Painful intercourse. Timepoint: Before and 7 days after the start of the intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Urinary incontinence. Timepoint: Before and 7 days after the start of the intervention. Method of measurement: پرسشنامه.</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>Alborz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-08-21</approval_date>
        <contact_name>Ethics committee of Alborz University of Medical Sciences</contact_name>
        <contact_address>Safarian Ave,Golshahr Ave,Alborz Medical Sciences Research and Technology Deputy Karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
