<?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>IRCT20150706023084N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-22</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Randomize comparison of Vaginal suppository containing zhumeria majdae essential oil with vaginal clotrimazole versus placebo vaginal suppository with vaginal clotrimazole for vulvovaginal candidiasis treatment</public_title>
      <acronym></acronym>
      <scientific_title>Randomize comparison of Vaginal suppository containing zhumeria majdae essential oil with vaginal clotrimazole versus placebo vaginal suppository with vaginal clotrimazole for vulvovaginal candidiasis treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58973</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: Vaginal suppositories of  Zhumeria majdae and placebo were made by
the researcher and placed in aluminum foils individually, and everyone except
the researcher was unaware of the drug composition.</study_design>
      <phase>1</phase>
      <hc_freetext>candidiasis vulvovaginit.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: It consists of 30 people, each of whom receives a 2-gram vaginal suppository containing 0.1 cc of Zhumeria maidae essential oil along with clotrimazole suppository every night for seven nights. Made in Tehran. Participants will be explained how to use the drug at the beginning of the study. Intervention 2: Control group:It consists of 30 people, each of whom receives a 2-gram placebo suppository with clotrimazole suppository every night for seven nights. The user will be explained at the beginning of the study how to use the drug.</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 امکان سواستفاده از داده ها در مطالعات مشابه دیگر کاهش می یابد درضمن نتایج مطالعه به صورت کامل در پایان نامه منتشر میگردد پس نیازی به انتشار داده های خام نیست</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sepideh Kermani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shokoofeh Alley, Nobahar St., Sepah Square</address>
        <city>Malayer</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۵۷۱۹۴۵۵۴۶</zip>
        <telephone>+98 81 3334 5700</telephone>
        <email>drskermani43@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sepideh Kermani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shokoofeh Alley, Nobahar St., Sepah Square</address>
        <city>Malayer</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6571945546</zip>
        <telephone>+98 81 3334 5700</telephone>
        <email>drskermani43@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>women aged 18 to 50 years
Married
lack of sensitivity to the plant compounds of Zhumeria majdae
lack of sensitivity to clotrimazole
signature the consent form to participate in the study Exclusioncriteria
Diagnosis of vaginal candidiasis infection</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>pregnancy and lactation
menopause
underlyingdiseases
forgetting a dose or more
patientunwillingness to continue treatme
menstruation during the study
abnormal uterine bleeding
sensitivity to Zhumeria majdae
sensitivity to clotrimazole</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>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: It consists of 30 people, each of whom receives a 2-gram vaginal suppository containing 0.1 cc of Zhumeria maidae essential oil along with clotrimazole suppository every night for seven nights. Made in Tehran. Participants will be explained how to use the drug at the beginning of the study</i_keyword>
      <i_keyword>Control group:It consists of 30 people, each of whom receives a 2-gram placebo suppository with clotrimazole suppository every night for seven nights. The user will be explained at the beginning of the study how to use the drug.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Itching. Timepoint: Start of study - 7 days after the start of the study. Method of measurement: Questionnaire -Complete a checklist to evaluate the symptoms of candidal vaginitis and then compare thefrequency of symptoms of candidal vaginitis within and between the two treatment groups.</prim_outcome>
      <prim_outcome>Discharge. Timepoint: Start of study - 7 days after the start of the study. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Inflammation. Timepoint: Start of study - 7 days after the start of the study. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-13</approval_date>
        <contact_name>Islamic Azad University of Medical Sciences, Tehran, Pharmacy and Pharmaceutical Sciences branches</contact_name>
        <contact_address>Islamic azad University of Medical Sciences , Pharmacy and Pharmaceutical Sciences Branch , Yakhchal St., Gholhak, Dr. Shariati St. Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
