<?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>IRCT20181219042047N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-01</date_registration>
      <primary_sponsor>Artesh University of Medical Sciences</primary_sponsor>
      <public_title>Effect of bromelain supplementation in head trauma patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of bromelain supplementation on oxidative stress, inflammatory markers and clinical outcomes in patients with traumatic brain injury admitted to the intensive care unit of Besat hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>58</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68625</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are categorized and randomly assigned to the bromelain or placebo group. In order to randomly assign the patients to two groups, the classified block randomization method will be used using the website www.sealedenvelope.com. People were classified based on age (18 to 40 years and 40 to 65 years), gender (male/female) and Apache score (0 to 35 and 35 to 71) and divide into the intervention or placebo group based on blocks of four. In order to randomly allocate and based on blocks, patients who are in each of the age, gender, and APACHE II score classes, are entered into the intervention or placebo group. Randomization is concealed in sequentially numbered, sealed, opaque envelopes, Blinding description: Before starting the study, all boxes containing bromelain or placebo for double-blind implementation are coded as A and B to blind the researcher and participants.</study_design>
      <phase>3</phase>
      <hc_freetext>traumatic brain injury.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: People will receive 200 mg of bromelain 3 times a day for 14 days. Intervention 2: Control group: Subjects will receive a placebo daily for 14 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 اطلاعات بیشتری وجود ندارد</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Said Hadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>AJA University Of Medical Sciences, Etemadzadeh street, West Fatemi street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411718541</zip>
        <telephone>+98 21 4382 2284</telephone>
        <email>s.hadinu@yahoo.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Said Hadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>AJA University Of Medical Sciences, Etemadzadeh street, West Fatemi street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411718541</zip>
        <telephone>+98 21 4382 2284</telephone>
        <email>s.hadinu@yahoo.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with moderate to severe traumatic brain injury hospitalized in the intensive care unit, 7≤GCS≤12
Age range from 18 to 65 years
Stability of hemodynamic and metabolic status in the first 24 to 48 hours
Having nutritional support for the patient through gavage
Willingness to cooperate and sign the informed consent form after being fully informed about the objectives and method of conducting the study by the person herself or her legal guardian.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having an underlying cancer disease, autoimmune diseases, congenital metabolic diseases, acute or chronic liver failure, chronic kidney failure, and acute kidney failure if the patient needs dialysis
pregnancy and breastfeeding
history of known food allergy
Unwillingness to participate in the study
suffering from sepsis or any acute or chronic infection
allergy to supplements</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S06.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified intracranial injury</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: People will receive 200 mg of bromelain 3 times a day for 14 days.</i_keyword>
      <i_keyword>Control group: Subjects will receive a placebo daily for 14 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>C reactive protein. Timepoint: At the beginning and 14 days after the intervention. Method of measurement: Serum measurement by enzyme-linked immunosorbent assay (ELISA) method.</prim_outcome>
      <prim_outcome>Erythrocyte sedimentation rate. Timepoint: At the beginning and 14 days after the intervention. Method of measurement: Special measuring kit.</prim_outcome>
      <prim_outcome>Malondialdehyde. Timepoint: At the beginning and 14 days after the intervention. Method of measurement: Special measuring kit.</prim_outcome>
      <prim_outcome>Total antioxidant capacity. Timepoint: At the beginning and 14 days after the intervention. Method of measurement: Special measuring kit.</prim_outcome>
      <prim_outcome>28 day and 60 day mortality. Timepoint: روز 28 و 60. Method of measurement: Registration of death in the patient's file.</prim_outcome>
      <prim_outcome>Interleukin-6. Timepoint: At the beginning and 14 days after the intervention. Method of measurement: Serum measurement by enzyme-linked immunosorbent assay (ELISA) method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Glasgow Coma Scale. Timepoint: The beginning of the study, day 7 and 14. Method of measurement: Glasgow coma scale score.</sec_outcome>
      <sec_outcome>Acute Physiology and Chronic Health Evaluation (APACHE II). Timepoint: The beginning of the study, day 7 and 14. Method of measurement: APACHE score.</sec_outcome>
      <sec_outcome>Sequential Organ Failure Assessment (SOFA). Timepoint: The beginning of the study, day 7 and 14. Method of measurement: SOFA score.</sec_outcome>
      <sec_outcome>Nutrition Risk in the Critically Ill (NUTRIC). Timepoint: The beginning of the study, day 7 and 14. Method of measurement: NUTRIC score.</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>Artesh University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-15</approval_date>
        <contact_name>Research Ethics Committees of AJA University of Medical Sciences</contact_name>
        <contact_address>AJA University Of Medical Sciences, Etemadzadeh street, West Fatemi street, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
