<?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>IRCT20130501013194N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-28</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Oleoyl ethanolamide (OEA) supplementation in patients with acute ischemic brain stroke</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Oleoyl ethanolamide (OEA) supplementation on blood hematological parameters, lipid profile, biomarkers of oxidative stress and inflammatory parameters in the blood of patients with acute ischemic brain stroke</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44304</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This is an interventional study with a randomized controlled trial study design. In this study, 40 patients referred to Sina Hospital of Hamadan (consecutively) with diagnosis of acute ischemic stroke physician will be included in the study. In this study, patients were randomly divided into two groups of Oleoyl ethanolamide and placebo with Allocation Concealment by random number table and based on their group of supplements receive the relevant for two months. They will receive a computer code. The personal code of any participant in this course of treatment is not disclosed. Treatment codes are revealed at the end of the study after the database is closed, Blinding description: Participants receive the relevant supplements for two months after obtaining written consent from the group in which they are located. They will receive a computer code. The personal code of any participant in this course of treatment is not disclosed. Treatment codes are revealed at the end of the study after the database is closed. Capsules and placebo are similar in appearance, so clinical caregivers, researchers, outcome assessors and data analysts and the Committee on Safety and Data Monitoring know patients only by code and do not know which patient received the supplement or placebo.</study_design>
      <phase>2</phase>
      <hc_freetext>Acute ischemic brain stroke.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: They take one oleoyl ethanolamide supplement (200 mg) daily for two months. Supplements are made by Karen. Intervention 2: Control group: They receive a placebo capsule daily (a capsule that is not Oleoyl ethanolamide but patients are not told) for 2 months.</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>Akram Ranjbar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fahmedeh Blvd., Hamedan university of medical sciences</address>
        <city>Hamdan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838678</zip>
        <telephone>+98 81 3827 4191</telephone>
        <email>a.ranjbar@umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Akram Ranjbar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fahmedeh Blvd., Hamedan university of medical sciences</address>
        <city>Hamdan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838678</zip>
        <telephone>+98 81 3827 4191</telephone>
        <email>a.ranjbar@umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to cooperate
Acute ischemic brain stroke (preferably under one month)</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>taking immunosuppressive drugs
History of rheumatic and collagenvascular diseases
History of recent infections (within 2 to 3 months)
Swallowing disorders that are unable to take medication
Sensitivity to compounds
No regular use of supplements
Not willing to cooperate
Diabetes
kidney disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I63.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cerebral infarction, unspecified</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: They take one oleoyl ethanolamide supplement (200 mg) daily for two months. Supplements are made by Karen.</i_keyword>
      <i_keyword>Control group: They receive a placebo capsule daily (a capsule that is not Oleoyl ethanolamide but patients are not told) for 2 months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Red blood cells. Timepoint: Before and after intervention. Method of measurement: Laboratory.</prim_outcome>
      <prim_outcome>White blood cells. Timepoint: Before and after intervention. Method of measurement: Laboratory.</prim_outcome>
      <prim_outcome>Platelets. Timepoint: Before and after intervention. Method of measurement: Laboratory.</prim_outcome>
      <prim_outcome>Alanine aminotransferase. Timepoint: Before and after intervention. Method of measurement: Laboratory.</prim_outcome>
      <prim_outcome>Aspartate aminotransferase. Timepoint: Before and after intervention. Method of measurement: Laboratory.</prim_outcome>
      <prim_outcome>Cholesterol. Timepoint: Before and after intervention. Method of measurement: Laboratory.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: Before and after intervention. Method of measurement: Laboratory.</prim_outcome>
      <prim_outcome>High density lipoprotein. Timepoint: Before and after intervention. Method of measurement: Laboratory.</prim_outcome>
      <prim_outcome>Low density lipoprotein. Timepoint: Before and after intervention. Method of measurement: Laboratory.</prim_outcome>
      <prim_outcome>Urea. Timepoint: Before and after intervention. Method of measurement: Laboratory.</prim_outcome>
      <prim_outcome>Creatinine. Timepoint: Before and after intervention. Method of measurement: Laboratory.</prim_outcome>
      <prim_outcome>Lipid peroxidation. Timepoint: Before and after intervention. Method of measurement: Using spectrophotometer.</prim_outcome>
      <prim_outcome>Protein oxidation. Timepoint: Before and after intervention. Method of measurement: Using spectrophotometer.</prim_outcome>
      <prim_outcome>Total antioxidant capacity. Timepoint: Before and after intervention. Method of measurement: Using spectrophotometer.</prim_outcome>
      <prim_outcome>Catalase activity. Timepoint: Before and after intervention. Method of measurement: Using spectrophotometer.</prim_outcome>
      <prim_outcome>Tumor necrosis factor alpha. Timepoint: Before and after intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Interleukin 17. Timepoint: Before and after intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Reactive Protein C. Timepoint: Before and after intervention. Method of measurement: Turbidometry.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-06</approval_date>
        <contact_name>Ethic committee of Hamedan University of Medical Sciences</contact_name>
        <contact_address>Fahmedeh Blvd., Hamedan University of Medical Sciences Hamedan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-07</approval_date>
        <contact_name>Ethic committee of Hamedan University of Medical Sciences</contact_name>
        <contact_address>Fahmedeh Blvd., Hamedan University of Medical Sciences Hamedan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-07</approval_date>
        <contact_name>Ethic committee of Hamedan University of Medical Sciences</contact_name>
        <contact_address>Fahmedeh Blvd., Hamedan University of Medical Sciences Hamedan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
