<?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>IRCT20190805044444N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-12</date_registration>
      <primary_sponsor>Shoushtar Faculty of Medical Sciences</primary_sponsor>
      <public_title>The effect of vaginal cream zizyphus spina(sider) leave in the treatment of candidacies vulvovaginitis.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of vaginal cream of zizyphus spina (sider) leave with clotrimazole vaginal cream on treatment of candidiasis vulvovaginitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41442</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples were randomly divided into permutation blocks with the size of block 6. The drugs used in this study were randomly assigned by the out-of-study list to the corresponding codes in the closed envelopes and then assigned to each patient who entered the study, Blinding description: Ziziphus spina-christi green leaves vaginal  cream was prepared by adding the extract to a suitable cream base (emulsion of water in oil) at concentrations of 5% . In the pharmacy, 1% of clotrimazole vaginal cream was prepared using the same base. All final products had the same appearance and an approved color was used to maintain uniformity. Microbiological and physicochemical tests (uniformity, physical stability, distribution, and acidity) were performed on the prepared formulations. Samples will be randomly assigned to A and B medication. Both Ziziphus spina-christi leaves vaginal  cream and clotrimazole 1% can be used with applicators and are named A and B because the researcher and research units are unaware of them.</study_design>
      <phase>N/A</phase>
      <hc_freetext>candidacies vulvovaginitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:vaginal cream of zizyphus spina (sider) leave  once applicator a day for 1 week. Intervention 2: Control group: Clotrimazole vaginal cream once applicator a day for 1 week.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The part of the data includes information about the main consequences or the like it is possible to share

When:
Start the access period 12 months after printing the results

To whom:
Only for researchers working in academic and scientific institutions will be available

Conditions:
The data was used to check fungal infections in other parts of the body.

Where to obtain:
By receiving the email of the responsible author at honarmandpour.a@gmail.com

How to obtain:
After requesting data by email, the data will be sent within 1-2 weeks

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azam Honarmandpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shoushtar Faculty of Medical Sciences, Alhadi Hospital, Rajaie BLV</address>
        <city>Shoushtar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6451684534</zip>
        <telephone>+98 61 3622 9544</telephone>
        <email>navarbaf_n@ajums.ac.ir</email>
        <affiliation>Shoushtar Faculty of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azam Honarmandpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shoushtar Faculty of Medical Sciences, Alhadi Hospital, Rajaie BLV</address>
        <city>Shoushtar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6451684534</zip>
        <telephone>+98 61 3622 9544</telephone>
        <email>navarbaf_n@ajums.ac.ir</email>
        <affiliation>Shoushtar Faculty of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Candidate vaginitis signs and symptoms in interview or observation and confirmation by laboratory study; married women between 20-45 years old; patients who had a single sexual partner and they themselves were the only sexual partner of their respective spouse; Informed consent to participate in the study.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Exclusion criteria: women who had used oral or topical antifungal drugs, corticosteroids and antibiotics 2 weeks before the study; Steroid medication use; IUD use; pregnancy; breast feeding; diabetes and immunodeficiency; Abnormal uterine bleeding; menstruation and side effects of the drug.</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:vaginal cream of zizyphus spina (sider) leave  once applicator a day for 1 week</i_keyword>
      <i_keyword>Control group: Clotrimazole vaginal cream once applicator a day for 1 week</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Compelet remission. Timepoint: 7days and 14 days after treatment. Method of measurement: Evaluation of clinical symptom's remission with questionnaire.</prim_outcome>
      <prim_outcome>Vaginal Culture Results. Timepoint: Before and 7 Day After intervention. Method of measurement: Esmear Vaginal.</prim_outcome>
      <prim_outcome>Vaginal pH. Timepoint: Before and 7 day After intervention. Method of measurement: By pH meter strips.</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>Shoushtar Faculty of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-10</approval_date>
        <contact_name>Ethics committee of shoushtar faculty of medical sciences</contact_name>
        <contact_address>Shoushtar Faculty of Medical Sciences,  Alhade hospital, Rajae BLV, Shoushtar shoushtar Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
