<?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>IRCT20181105041563N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-01</date_registration>
      <primary_sponsor>Vice chancellor for research, Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>Comparative evaluation of the effect of Aloe Vera Gel, Olive oil  and Compound Aloe Vera Gel- Olive oil  on Prevention of pressure ulcer</public_title>
      <acronym></acronym>
      <scientific_title>Comparative evaluation of the effect of Aloe Vera Gel, Olive oil  and Compound Aloe Vera Gel- Olive oil  on Prevention of pressure ulcer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35560</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Qualified samples were entered into the study by accessible method and randomly divided into intervention groups (Aloe Vera Gel, olive oil and Combination of Aloe Vera Gel and olive oil) and control. Blocks were done as follows: To dressing groups with Aloe Vera Gel, sildenafil Ointment and Combination of Aloe Vera Gel and olive oil was assigned  A ، B and C codes respectively, and the control group received D code. The study blocks were ABCD, ABDC, ACBD, ACDB, ADBC, ADCB, and the ABCD block was selected as the first block. Patients were assigned to Aloe Vera Gel, olive oil,Combination of Aloe Vera Gel and olive oil , and control groups, respectively, and this method continued until the samples were completed.</study_design>
      <phase>2-3</phase>
      <hc_freetext>pressure ulcer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group 1: The areas under pressure will be rubbed three times a day, with Aloe Vera gel for 30 days, at 8:00 am and these areas in every other day will be examined by Braden and NPUAP criteria up to 30 days. The brand of this gel is Aloe Vera gel and its scientific name is Aloe Barbadensis Miller. Intervention 2: Intervention group: Group 2: The areas under pressure will be rubbed three times a day, with olive oil for 30 days, at 8:00 am and these areas in every other day will be examined by Braden and NPUAP criteria up to 30 days. Intervention 3: Intervention group: Group 3: The areas under pressure will be rubbed three times a day, with a combination of Olive oil and Aloe Vera in 2: 3 ratio for 30 days, at 8:00 am and these areas in every other day will be examined by Braden and NPUAP criteria up to 30 days. Intervention 4: Control group: Group 4: There is no intervention in the control group.The areas under pressure will be checked in every other day by Braden and NPUAP criteria up to 30 days.</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 There is no specific program for publishing this project currently</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Somayeh Mahdavikian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715986479</zip>
        <telephone>+98 83 3816 2560</telephone>
        <email>Somayeh.Mahdavikian@kums.ac.ir</email>
        <affiliation>Kermanshah School of Nursing and Midwifery</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Somayeh Mahdavikian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715986479</zip>
        <telephone>+98 83 3816 2560</telephone>
        <email>Somayeh.Mahdavikian@kums.ac.ir</email>
        <affiliation>Kermanshah School of Nursing and Midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Consent of the physician and the patient to participate
Insensitivity to Aloe vera and olive oil
no skin disease, cancer, diabetes,nervous and psychotic disorder and kidney failure
Non-use of nitroglycerin
no addiction to drugs and alcohol
earn points equal to 14-6 from Braden scale
lack of pressure ulcer in order to NPUAP scale
Non-use ofimmunosuppressive drugs
having aged over 18 years
No bleeding,</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>reluctance to continue cooperation
earn points more than 18 from Braden scale
Administration of nitroglycerin and immunosuppressive drugs,
need for any surgery
Reduction of platelets and hemoglobin,
Occurrence of pressure ulcer in order to NPUAP scale</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L89</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Decubitus ulcer and pressure area</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group 1: The areas under pressure will be rubbed three times a day, with Aloe Vera gel for 30 days, at 8:00 am and these areas in every other day will be examined by Braden and NPUAP criteria up to 30 days. The brand of this gel is Aloe Vera gel and its scientific name is Aloe Barbadensis Miller.</i_keyword>
      <i_keyword>Intervention group: Group 2: The areas under pressure will be rubbed three times a day, with olive oil for 30 days, at 8:00 am and these areas in every other day will be examined by Braden and NPUAP criteria up to 30 days.</i_keyword>
      <i_keyword>Intervention group: Group 3: The areas under pressure will be rubbed three times a day, with a combination of Olive oil and Aloe Vera in 2: 3 ratio for 30 days, at 8:00 am and these areas in every other day will be examined by Braden and NPUAP criteria up to 30 days.</i_keyword>
      <i_keyword>Control group: Group 4: There is no intervention in the control group.The areas under pressure will be checked in every other day by Braden and NPUAP criteria up to 30 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Prevention of pressure ulcer. Timepoint: At 8 o'clock in the morning, every other day, up to 30 days,. Method of measurement: braden and NPUAP scales.</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>Vice chancellor for research, Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-11-29</approval_date>
        <contact_name>Ethics committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Kermanshah University of Medical Sciences, Shahid Beheshty Blv, Kermanshah University of Medical Sciences, Kermanshah, Iran Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
