<?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>IRCT20080901001174N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-26</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Edible herbal oils on wound size</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of oral Flaxseed oil And Olive oil on wound size and Inflammation markers in burn patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>112</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29848</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients who referred to this center with% 20-50% burns are randomly divided into four groups using randomized blocks. Intervention variables include age and sex, and patients under the transplanted skin that can be controlled and categorized in a random blocked stratified method, Blinding description: Odorless olive oil and flaxseed oil in dark glass without the name (nickname) are prepared and maintained by the Investigator. Not patients, nor nutritionists, know the type of oil. Vegetable oil is intended for use by a Nutritionist who does not know about the contents of the glass in the patient's salad, or if the patient is discharged, dark glass bottle contains unnamed oil, would be Available to the patient. It should be noted that both oils are golden yellow. Flaxseed oil has very little odor for 7 days and can not be distinguished from odorless olive oil.</study_design>
      <phase>3</phase>
      <hc_freetext>Wound size.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: 28 patients are in group A and receive 30 cc of olive oil mixed with salad, daily, in a meal for 21 consecutive days.Extra virgin olive oil from olives was prepared by household oiling machines. Analysis of fatty acid profiles and antioxidants and its polyphenols by GC / MS machine in Raymi chemical specialty lab using gas chromatography and spectroscopy at www.afshinrahimilab.com will be done. Intervention 2: Intervention group 2:  28 patients are in group B and receive 30 cc of Flaxseed oil mixed with salad, daily, in a meal for 21 consecutive days. Extract of flaxseed oil from flaxseed was prepared by household oiling machines. Analysis of fatty acid profiles and antioxidants and its polyphenols by GC / MS machine in Raymi chemical specialty lab using gas chromatography and spectroscopy at www.afshinrahimilab.com will be done. also, titration of peroxide endometritis on flaxseed oil will be done and will be expressed in milligrams of active oxygen in a kilogram of oil. Intervention 3: Intervention group 3: 28 patients are in group D and receive 15 ccs of Flaxseed oil mixed with 15 ccs of olive oil salad, daily, in a meal for 21 consecutive days. Intervention 4: Control group:  28 patients are in group C and they will eat the salad without oil In a meal, for 21 consecutive days. Patients'salads are based on the diet adjusted by the nutritionist to suit each patient. All four groups will receive routine treatment, which includes vitamin E and vitamin A on a daily basis.</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:
Main and total Data

When:
starting in 2018

To whom:
Universities and scientific institutions

Conditions:
If they cite the article

Where to obtain:
executor of proposal

How to obtain:
Contact with proposal executor  and making ethical agreement

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atefeh Ghanbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Daneshjo street,Shahid Beheshti Highway, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3984141469</zip>
        <telephone>+98 33555056</telephone>
        <email>at_ghanbari@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atefeh Ghanbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Daneshjo street,Shahid Beheshti Highway, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3984141469</zip>
        <telephone>+98 33555056</telephone>
        <email>at_ghanbari@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age of 15–65 years
Body mass index (BMI) of 18–30 kg/m2
Hospitalization for more than 24 hours
Admittion within 24 - 48 h post-burn
Willingness to participate
Able to feed through the mouth</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Infected burn wounds
Cases of chronic and underlying diseases
Allergy to Flaxseed  oil And Olive oil
The history of taking omega-3 and omega-6 in the previous week or month
pregnant and lactating women
Smoking</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: 28 patients are in group A and receive 30 cc of olive oil mixed with salad, daily, in a meal for 21 consecutive days.Extra virgin olive oil from olives was prepared by household oiling machines. Analysis of fatty acid profiles and antioxidants and its polyphenols by GC / MS machine in Raymi chemical specialty lab using gas chromatography and spectroscopy at www.afshinrahimilab.com will be done.</i_keyword>
      <i_keyword>Intervention group 2:  28 patients are in group B and receive 30 cc of Flaxseed oil mixed with salad, daily, in a meal for 21 consecutive days. Extract of flaxseed oil from flaxseed was prepared by household oiling machines. Analysis of fatty acid profiles and antioxidants and its polyphenols by GC / MS machine in Raymi chemical specialty lab using gas chromatography and spectroscopy at www.afshinrahimilab.com will be done. also, titration of peroxide endometritis on flaxseed oil will be done and will be expressed in milligrams of active oxygen in a kilogram of oil.</i_keyword>
      <i_keyword>Intervention group 3: 28 patients are in group D and receive 15 ccs of Flaxseed oil mixed with 15 ccs of olive oil salad, daily, in a meal for 21 consecutive days.</i_keyword>
      <i_keyword>Control group:  28 patients are in group C and they will eat the salad without oil In a meal, for 21 consecutive days. Patients'salads are based on the diet adjusted by the nutritionist to suit each patient. All four groups will receive routine treatment, which includes vitamin E and vitamin A on a daily basis.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Wound size. Timepoint: Before intervention and 2, 9, 15, and 22 days after the intervention. Method of measurement: Getting photo from burn injury and measure the length and width of the wound to measure the area of the wound; Canon's camera model and a standard ruler will be used for this purpose. The area of the wound is measured by the AutoCAD software. Changing the area and the appearance of the wound will be considered as wound healing. When the wound appearance become pink and transparent with the non-secreting epithelium the wound will be considered as healed wound.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hs-CRP. Timepoint: At the beginning and at the end of the study. Method of measurement: Blood test.</sec_outcome>
      <sec_outcome>Ferritin. Timepoint: At the beginning and at the end of the study. Method of measurement: Blood test.</sec_outcome>
      <sec_outcome>Albumin. Timepoint: At the beginning and at the end of the study. Method of measurement: Blood test.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-26</approval_date>
        <contact_name>Ethical committee, Guilan University of Medical Sciences</contact_name>
        <contact_address>Guilan University of Medical Sciences, Namjoo Street Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
