<?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>IRCT20160914029817N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-29</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of Olive and Bitter almonds on pressure  ulcers</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Bitter almonds and Olive oil on the prevention of pressure ulcers in intensive Care units Pationt</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-02-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34348</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Block Randomize، The subjects are randomly assigned into three groups using software, Blinding description: Participants in the study do not know which oils are used on their skin.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pressure ulcer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  First intervention group: Use of  Olive oil from a reliable exir factory, which has been standardized on this product under laboratory conditions. This product has the standard code and Apple health mark of Iranian Food and Drug Administration and the register number is 10124.39، In  addition to the usual treatments for the section's implementation that basically change the situation every two hours once and use the Wavy mat. Intervene in both groups for 2 weeks every 24 hours. Sacrum, Batex and Sacred Squares: 1 cc, Heels: 0/5cc, Batex:1/5cc Will Be Made. Intervention 2: Intervention group: Second intervention group: Use of bitter almond oil from a reliable factory of natural extract of Nowshad brand that has been prepared according to the standards approved by the Food and Drug Administration of Iran and has the and Apple health mark of Iranian Food and Drug Administration and the register number is 1228208485، In  addition to the usual treatments for the section's implementation that basically change the situation every two hours once and use the Wavy mat. Intervene in both groups for 2 weeks every 24 hours.  Sacrum, Batex and Sacred Squares: 1 cc, Heels: 0/5cc, Batex:1/5cc Will Be Made.</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 Failure to complete the plan</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shohreh Saljoghiyan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Nursing and Midwifery Faculty, Kerman University of Medical Sciences, beginning of the Haft Bagh Alavi Highway , Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 32119021</telephone>
        <email>s.saljoghiyan1985@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Smat nohi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Nursing and Midwifery Faculty، University of Medical Sciences،beginning of the Haft BaghAlavi High way، Kermann</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616931555</zip>
        <telephone>+98 34 3132 5220</telephone>
        <email>e_nuhi@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a Norton Criterion is less or equal 16
Having a Foley catheter</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Dissatisfaction with Ghayumin
having diabetes
Having a pressure ulcer
Observe any skin symptoms caused by drug allergy (rash, hives, redness, swelling).
Having skin problems
The presence of allergens to bitter bitter olives and their products</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L89.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Stage II decubitus ulcer</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  First intervention group: Use of  Olive oil from a reliable exir factory, which has been standardized on this product under laboratory conditions. This product has the standard code and Apple health mark of Iranian Food and Drug Administration and the register number is 10124.39، In  addition to the usual treatments for the section's implementation that basically change the situation every two hours once and use the Wavy mat. Intervene in both groups for 2 weeks every 24 hours. Sacrum, Batex and Sacred Squares: 1 cc, Heels: 0/5cc, Batex:1/5cc Will Be Made</i_keyword>
      <i_keyword>Intervention group: Second intervention group: Use of bitter almond oil from a reliable factory of natural extract of Nowshad brand that has been prepared according to the standards approved by the Food and Drug Administration of Iran and has the and Apple health mark of Iranian Food and Drug Administration and the register number is 1228208485، In  addition to the usual treatments for the section's implementation that basically change the situation every two hours once and use the Wavy mat. Intervene in both groups for 2 weeks every 24 hours.  Sacrum, Batex and Sacred Squares: 1 cc, Heels: 0/5cc, Batex:1/5cc Will Be Made.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Create a pressure ulcer. Timepoint: Evaluation of pressure ulcers at the beginning of the study and  Two weeks after the intervention. Method of measurement: Grading system for the substrate wound panel.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-11-21</approval_date>
        <contact_name>Ethical committee of kerman University of Medical Sciences</contact_name>
        <contact_address>University of Medical Sciences, Haft Bagh Alavi, Kerman Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
