<?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>IRCT20150519022320N20</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-10-11</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>Comparative investigating of the Effect of Aloe Vera gel and Olive Oil on Incidence of pressure ulcer in patients Hospitalized</public_title>
      <acronym></acronym>
      <scientific_title>Comparative investigating of the Effect of Aloe Vera gel and Olive Oil on Incidence of pressure ulcer in patients Hospitalized in units of Aliebn-abitaleb Hospital, Rafsanjan  2019</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38444</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Based on the Braden criterion, people with a moderate and severe risk of pressure ulcer are identified.then, 120 people are selected for entry criteria. Subsequently, according to the random block method, people are divided into four groups of 30 with titles A, B, C, D. A {Aloe vera-Placebo group}
B {olive oil - placebo group }
C {Olive Oil - Aloe Vera group }
D {control group}, Blinding description: The patient, the outcome assessor and the Data analyer are not aware of the type of substance used.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pressure ulcer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group A: Each person in this group receives  an Aloe vera gel on one side of his sacrum and iliac, and on the other side he receives a placebo (a lubricant gel) at 5 cc  twice a day for seven days.in addition to he receives Routine care, involves changing the patient's position every 2 hours and using wavy mattresses. Intervention 2: Intervention group: intervention group B: Each person in this group receives olive oil on one side of his sacrum and his iliac, and on the other side he receives a placebo (glycerin oil) at 5 cc twice a day for seven days.in addition to he receives Routine care, involves changing the patient's position every 2 hours and using wavy mattresses. Intervention 3: Intervention group C: Each person in this group receives olive oil on one side of his sacrum and his iliac, and on the other side he receives Aloe Vera gel at 5 cc twice a day for seven days.in addition to he receives Routine care, involves changing the patient's position every 2 hours and using wavy mattresses. Intervention 4: Control group: Group D: No intervention other than routine care.</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 Confidentiality of information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tayebeh Mirzaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Parastar Ave.</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718796755</zip>
        <telephone>+98 34 3452 5900</telephone>
        <email>t.mirzaei@rums.ac.ir</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Tayebeh Mirzaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Geriatric Care Research Center, Jomhoori Eslami Bolv</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718174715</zip>
        <telephone>+98 34 3425 5900</telephone>
        <email>t.mirzaei@rums.ac.ir</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclination to participate in research
Age over 18 years
Braden score less than 14
Lack of diabetes
Lack of skin diseases (such as psoriasis, fungal disease)
Lack of pressure ulcer beforehand
Having a systolic blood pressure of 10 mm Hg and above
Not having fever (Body temperature higher than 38/8)
Hemoglobin higher than 12 mg / dl
No history of allergy to olive oil and aloe vera gel and their products</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Not willing to continue participating in the study
Reduced hemoglobin levels during the study to less than 12 mg / dL in men and less than 10 in women
Reduced blood pressure to less than 100 mmHg
Hyperthermia (temperature higher than 38.8) during the study
Sensitization to olive oil, Aloe vera gel, placebo and any other medicine.
Transferring the patient to another care center
Increase Braden Score to over 14
Patient's death</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L89</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pressure ulcer</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group A: Each person in this group receives  an Aloe vera gel on one side of his sacrum and iliac, and on the other side he receives a placebo (a lubricant gel) at 5 cc  twice a day for seven days.in addition to he receives Routine care, involves changing the patient's position every 2 hours and using wavy mattresses.</i_keyword>
      <i_keyword>Intervention group: intervention group B: Each person in this group receives olive oil on one side of his sacrum and his iliac, and on the other side he receives a placebo (glycerin oil) at 5 cc twice a day for seven days.in addition to he receives Routine care, involves changing the patient's position every 2 hours and using wavy mattresses.</i_keyword>
      <i_keyword>Intervention group C: Each person in this group receives olive oil on one side of his sacrum and his iliac, and on the other side he receives Aloe Vera gel at 5 cc twice a day for seven days.in addition to he receives Routine care, involves changing the patient's position every 2 hours and using wavy mattresses.</i_keyword>
      <i_keyword>Control group: Group D: No intervention other than routine care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Incidence or absence of pressure ulcers. Timepoint: Evaluate skin samples after using the ingredients every 24 hours for seven days. Method of measurement: check list of pressure ulcer.</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>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-15</approval_date>
        <contact_name>Ethics committee of Rafsanjan University of Medical Sciences</contact_name>
        <contact_address>Emam Ali Blv, Central Organization of the Central Organization of Medical Sciences Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
