<?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>IRCT20230521058245N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-27</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>Determining and comparing the effect of Clotrimazole vaginal cream and vaginal cream (Jashir plant) on candidal vulvovaginitis</public_title>
      <acronym></acronym>
      <scientific_title>Determining and comparing the effect of Clotrimazole vaginal cream and Prongus Fluorase vaginal cream (Jashir plant) on candidal vulvovaginitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>104</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70331</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: For sampling, the available sample method is used, then the research units are placed in two parallel groups by a simple random allocation method using a table of random numbers. 56 women are in clotrimazole vaginal cream users group and 56 women are in Jashir vaginal cream group, Blinding description: All people, including the researcher, the patient and the statistical analyst, are blinded to the drug allocation. The pharmacist will perform drug blinding. In order to blind Clotrimazole 1% cream made by a pharmaceutical company, under sterile conditions, it is emptied by the pharmacist into tubes similar to Jashir's vaginal cream tubes, then in order to differentiate the two drugs, they are coded as A and B codes by the pharmacist for each Vaginal cream is determined and after the study and statistical analysis, the code of each drug is stated by the pharmacist. The research team includes a gynecologist, a pharmacist and a midwife.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Candidal vulvovaginitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Intervention group: Jashir vaginal cream for one week, one 5 mg applicator every night at bedtime vaginally. Intervention 2: Control group: Clotrimazole vaginal cream for one week, one 5 mg applicator every night at bedtime vaginally.</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:
Individual data of participants by de-identifying individuals, research results

When:
Access period from 1402 to one year

To whom:
All researchers in academic and scientific institutions

Conditions:
Study method and statistical analysis

Where to obtain:
To the email address sf.hekmatzadeh@yahoo.com
Yasuj University of Medical Sciences, Fatemeh Hekmatzadeh

How to obtain:
Request by email or attendance at Yasouj University of Medical Sciences

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Hekmatzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 402, Beach Park towards Imam Sajjad Hospital, Yasouj,  Kohgiluyeh and Boyerahmad province</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591741417</zip>
        <telephone>+98 74 3323 5145</telephone>
        <email>sf.hekmatzadeh@yahoo.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Hekmatzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 402, Beach Park towards Imam Sajjad Hospital, Yasouj,  Kohgiluyeh and Boyerahmad province</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591741417</zip>
        <telephone>+98 74 3323 5145</telephone>
        <email>sf.hekmatzadeh@yahoo.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women of reproductive age (15 to 45 years)
Being married
Having at least two symptoms of cheesy secretions and itching
Least a Sobel score of 4
Positive culture</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Failure to participate in the study
Lactating women
Menopausal women
Menstruation
Pregnant women
Having diabetes
Women with immunodeficiency and immunosuppressive diseases
Suffering from other vaginal infections and sexually transmitted infections
Frequent and recurring candidal vulginitis
History of allergy to Jashir</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:Intervention group: Jashir vaginal cream for one week, one 5 mg applicator every night at bedtime vaginally</i_keyword>
      <i_keyword>Control group: Clotrimazole vaginal cream for one week, one 5 mg applicator every night at bedtime vaginally</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Although vaginitis is a candidate. Timepoint: Before the start of the intervention and 7 days after the end of the intervention. Method of measurement: The score obtained from Sobel clinical semi-quantitative system.</prim_outcome>
      <prim_outcome>Dysparonychia due to candidal vulvovaginitis. Timepoint: Dysparonychia due to candidal vulvovaginitis. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Burning of the vulva and vagina. Timepoint: before the start of the intervention and 7 days after the end of the intervention. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>White cheesy discharge. Timepoint: before the start of the intervention and 7 days after the end of the intervention. Method of measurement: According to the score obtained from the Sobel scoring system.</prim_outcome>
      <prim_outcome>Edema vulva. Timepoint: before the start of the intervention and 7 days after the end of the intervention. Method of measurement: According to the score obtained from the Sobel scoring system.</prim_outcome>
      <prim_outcome>Itching of the vulva and vagina. Timepoint: before the start of the intervention and 7 days after the end of the intervention. Method of measurement: Visual Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Improvement of candidal vaginitis. Timepoint: 7 days after the end of the intervention. Method of measurement: Removal of symptoms and signs at the beginning and total Sobel severity score ≤ 2 and negative culture.</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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-19</approval_date>
        <contact_name>Ethics Committee of Yasouj University of Medical Sciences</contact_name>
        <contact_address>No 402، Beach Park towards Imam Sajjad Hospital،Yasouj ،Kohgiluyeh and Boyerahmad province Yasouj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
