<?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>IRCT20150706023084N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-10</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Randomize comparison of vaginal suppository containing cuminum cyminum essential oil with vaginal clotrimazole versus placebo vaginal suppository for vulvovaginal candidiasis treatment</public_title>
      <acronym></acronym>
      <scientific_title>Randomize comparison of vaginal suppository containing cuminum cyminum essential oil with vaginal clotrimazole versus placebo vaginal suppository 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/58977</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 cuminum cyminum and placebo were made by the researcher and were placed in aluminum foils individually , and everyone except the researcher was unaware of the composition of these drugs.</study_design>
      <phase>1</phase>
      <hc_freetext>Candidiasis vulvovaginitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: consist of 30 people who each receive a 2 gram vaginal suppository containing 0.1 cc of cuminum cyminum essential oil along with clotrimazole vaginal suppository daily for seven days (clotrimazole at night and cuminum cyminum suppository in the morning or noon). Cuminum cyminum suppository is based on polyethylene glycol 1000 and 4000 at the rate of 80% and 20% which is made in Tehran Azad University of Medical Sciences, Department of Pharmacy and Pharmaceutical Sciences. Participants will be explained  how to use the drug at the beginning of the study . Intervention 2: Control group: Including 30 patients, each receiving a clotrimazole vaginal suppository and a placebo suppository daily for seven days (clotrimazole at night and placebo in the morning or at noon).</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 1. Do not misuse information in similar research and data processing according to them
2. Because the results are reported in thesis, it is not necessary to publish raw data.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>FatemehSadat Abtahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 26, No 41, Nasser Tanha Alley,  Berezent St. , 45metri Golshahr St.</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3198747447</zip>
        <telephone>+98 26 3460 0554</telephone>
        <email>fatemehabtahi21@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Sadat Abtahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>unit26, No41,Nasser Tanha Alley, Berezent St.,45 metri Golshahr St.</address>
        <city>karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3198747447</zip>
        <telephone>+98 26 3460 0554</telephone>
        <email>fatemehabtahi21@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women aged 18 - 50 years old
Being married
Signature of consent
Diagnosis of candidiasis infection
lack of sensitivity to cuminum cyminum or clotrimazole</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Pregnancy
lactation
menopause
Underlying diseases
Menstruation during the study
Forget one dose or more of medication
Allergy to clotrimazole or cuminum cyminum suppository
The patient's unwillingness to continue treatment
Abnormal uterine bleeding</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: consist of 30 people who each receive a 2 gram vaginal suppository containing 0.1 cc of cuminum cyminum essential oil along with clotrimazole vaginal suppository daily for seven days (clotrimazole at night and cuminum cyminum suppository in the morning or noon). Cuminum cyminum suppository is based on polyethylene glycol 1000 and 4000 at the rate of 80% and 20% which is made in Tehran Azad University of Medical Sciences, Department of Pharmacy and Pharmaceutical Sciences. Participants will be explained  how to use the drug at the beginning of the study .</i_keyword>
      <i_keyword>Control group: Including 30 patients, each receiving a clotrimazole vaginal suppository and a placebo suppository daily for seven days (clotrimazole at night and placebo in the morning or at noon).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Itching. Timepoint: Beginning of the study - 7 days after the start of the study. Method of measurement: Questionnaire  - completing a checklist to evaluate the symptoms of candidal vaginitis  and then compare the frequency of symptoms of candidial vaginitis within and between the two treatment groups.</prim_outcome>
      <prim_outcome>Discharge. Timepoint: Beginning of the study - 7 days after the start of the study. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Inflammation. Timepoint: Beginning of the 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>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>
