<?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>IRCT2016071929004N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-10-12</date_registration>
      <primary_sponsor>Vice chancellor for research, Kerman University Of Medical Sciences</primary_sponsor>
      <public_title>The effect of dill  vaginal cream on treatment of candida vaginitis</public_title>
      <acronym></acronym>
      <scientific_title>The comparision effect of  Anethum graveolens L. (dill)  products on traditional medicine base with clotrimazole cream 1% on vaginal candidiasis.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-07-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>105</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23406</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomised(Blocked randomization), case control,double blind , study in single field  and control with standard treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>vulvovaginal Candidiasis.</hc_freetext>
      <i_freetext>Intervention 1: using one applicator of Essential oil of Anethum graveolens L. (Dill) vaginal cream (2%) every night for 7 nights. Intervention 2: using one applicator of  Clotrimazole vaginal cream 1% every night for 7 nights . Intervention 3: using one applicator of total extract of dill  vaginal cream (2%)  every night for 7 nights .</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>Zohreh Sarhadinejhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Modiriat avenue ,  Traditional Medicine College</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0098347615687644</zip>
        <telephone>00983433122020; 00983433122023; 00983431325720</telephone>
        <email>z_sarhadinejhad@kmu.ac.ir; dr_isac1390@ yahoo.com</email>
        <affiliation>Kerman University Of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Zohreh Salari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Afzalipoor Hospital, Emam Freeway.</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 343322225060</telephone>
        <email>Zohreh_salari@yahoo.com; z_sarhadinejhad@kmu.ac.ir; dr_isac1390@ yahoo.com</email>
        <affiliation>Kerman University Of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:  sign and symptoms of vulvovaginal candidiasis;  married women; between 18 to 65 years old; with positive sniff test; without  pregnancy, without breast feeding, without chronic disease such as (kidney ,liver, cardiac disease and diabetes ), no existance of immunodeficiency nor complicated vaginal candidiasis on diagnosis of gynecologist and not  using of  systemic  antibiotics and immunosuppressive drugs, or any vaginal drugs during the study and not using of systemic anti fungal drugs since 4 weeks ago.&#13;
 Exclusion criteria:  side effects or drug reaction; pregnancy; menstruate; lack of patient's association.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></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>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>using one applicator of Essential oil of Anethum graveolens L. (Dill) vaginal cream (2%) every night for 7 nights.</i_keyword>
      <i_keyword>using one applicator of  Clotrimazole vaginal cream 1% every night for 7 nights .</i_keyword>
      <i_keyword>using one applicator of total extract of dill  vaginal cream (2%)  every night for 7 nights .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Burning. Timepoint: at the beginning and 10 days after intervention. Method of measurement: Evaluation of clinical symptom's remission(burning) with VSQ (vulvovaginal symptom questionnaire).</prim_outcome>
      <prim_outcome>Itching. Timepoint: at the beginning and 10 days after intervention. Method of measurement: Evauation of clinical symptom's remission (itching) with VSQ (vulvovaginal symptom questionnaire).</prim_outcome>
      <prim_outcome>Vaginal discharge. Timepoint: at the beginning and 10 days after intervention. Method of measurement: Evaluation of clinical symptom's remission (vaginal discharge) with VSQ (vulvovaginal symptom questionnaire).</prim_outcome>
      <prim_outcome>Erithema. Timepoint: at the beginning and 10 days after intervention. Method of measurement: physical exam.</prim_outcome>
      <prim_outcome>Edema. Timepoint: at the beginning and 10 days after intervention. Method of measurement: physical exam.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sniff test outcome. Timepoint: at the beginning and 10 days after intervention. Method of measurement: vaginal 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>Vice chancellor for research, Kerman University Of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-07-13</approval_date>
        <contact_name>Ethical Committee of Kerman University Of Medical Sciences</contact_name>
        <contact_address>Kerman University Of Medical Sciences Paradise, Haftbagh freeway. kerman  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
