<?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>IRCT20190120042436N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-10</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>Effect of (Salvia officinalis L.)  ointment on diaper-induced dermatitis in children</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of (Salvia officinalis L.)  ointment and common treatment on diaper-induced dermatitis in children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50379</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on a simple random method, each person who meets the inclusion criteria is assigned to one of the two groups of intervention or routine treatment by lot, Blinding description: In this study, the participants do not know that they are in which of the groups under study, while the ward nurse as a clinical caregiver and the doctor as an outcome assessor does not know the type of interventions performed for patients. The data analyzer also does not know the allocation of study groups because it will be specified as A and B.</study_design>
      <phase>3</phase>
      <hc_freetext>Diapper Rash.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Treated with Salvia officinalis L.ointment which contains 28% hydroalcoholic extract of the aerial part of the plant contains leaves, flowers and stems and similar to Salvizan gel. After washing and drying the dermatitis area, depending on the extent of dermatitis, this ointment will be used 3 times a day for a maximum of 7 days to cover the surface of the dermatitis skin (1 Centimeter). Intervention 2: Control group: Treated with routine treatment (Zinc oxide and Hydrocortisone Ointments). Depending on the extent of dermatitis, these ointments will be used 3 times a day for a maximum of 7 days to cover the surface of the skin (1 Centimeter).</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohsen Salari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Dr. Jalil St., Nursing School of Hazrat Zaynab (SA), Yasuj, Iran</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>75919-94799</zip>
        <telephone>+98 74 3323 5140</telephone>
        <email>salarimo@yums.ac.ir</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohsen Salari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Dr. Jalil St., Faculty of Nursing, Yasuj, Iran</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>75919-94799</zip>
        <telephone>+98 74 3323 5140</telephone>
        <email>salarimo@yums.ac.ir</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. Children under two years of age 2 - use disposable diapers or disposable pad. 3. Lack of recognized immune system weakness. (based on the physician diagnosis.)4. do not use certain drugs to suppress immune system5- Lack of specific food and drug allergies 6 - Lack of specific skin sensitivity. 7. Lack of extensive skin infections 8 - Parents tend to participate in the study.</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>2 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1. Discontinue treatment or change treatment for any reason during the treatment period. 2- In case of occurrence and identification of a new problem affecting the child's rash.  3-People who take care of a new drug and especially a plant to treat  dermatitis.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L22</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diaper dermatitis</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: Treated with Salvia officinalis L.ointment which contains 28% hydroalcoholic extract of the aerial part of the plant contains leaves, flowers and stems and similar to Salvizan gel. After washing and drying the dermatitis area, depending on the extent of dermatitis, this ointment will be used 3 times a day for a maximum of 7 days to cover the surface of the dermatitis skin (1 Centimeter).</i_keyword>
      <i_keyword>Control group: Treated with routine treatment (Zinc oxide and Hydrocortisone Ointments). Depending on the extent of dermatitis, these ointments will be used 3 times a day for a maximum of 7 days to cover the surface of the skin (1 Centimeter).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Percentage of people whose severity and extent of dermatitis is equal to or greater than average based on checklists. Timepoint: The beginning of the study, the second, fourth and sixth day after starting treatment. Method of measurement: A five-point scale is used to measure the severity and extent of diaper rash, and a Modified Behavioral Pain Scale is used for pain.</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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-08</approval_date>
        <contact_name>Ethics committee of Yasuj University of Medical Sciences</contact_name>
        <contact_address>Shahid Jalil Street. Educational Pardis, Yasuj. Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
