<?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>IRCT20090306001747N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-12</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of phytosomal curcumin supplementation in multiple trauma</public_title>
      <acronym></acronym>
      <scientific_title>The effect of phytosomal curcumin supplementation on inflammation, length of stay and 28-day mortality in multiple trauma patients admitted to the intensive care unit (ICU): a double-blind randomized controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52692</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: For randomization, the randomized blocking method and spss software will be used, so that according to the sample size, the size of the blocks is 4 and AABB combinations will be used. In the following, all possible modes of the combination of 4 will be listed and for each one, a code will be considered and individuals will be assigned based on them.This will be done using a random number table, Blinding description: In order to this research to be double-blind, at the beginning of the study, a set of cans containing curcumin and placebo supplements that are similar in shape and appearance were coded as A and B by someone other than the researcher, then a person who has no information about supplements and placebo The group that does not know whether it is a supplement or a placebo is poured into cans A and the other group into cans B so that the researchers and participants do not know the type of supplement received by each group.</study_design>
      <phase>3</phase>
      <hc_freetext>sepsis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients receiving two 250 mg curcumin-phytosomal capsules (total of 500 mg daily) for 7 days (25 patients). Intervention 2: Control group: Patients receiving placebo for 7 days, two 250 mg maltodextrin capsules per day (25 patients).</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:
All data can be shared after people have requested.

When:
Six months after publishing the results.

To whom:
Academic researchers

Conditions:
Scientific uses

Where to obtain:
By sending an email to the following address that belongs to the executor of the project
s_abbasi@med.mui.ac.ir

How to obtain:
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Bagherniya</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>hezarjarib</address>
        <city>esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3620 1293</telephone>
        <email>bagherniya@nutr.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Bagherniya</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>hezarjarib</address>
        <city>esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3620 1293</telephone>
        <email>bagherniya@nutr.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18-70 years
Gastrointestinal tract with normal function and intestinal nutrition criteria
Diagnosis of moderate or severe trauma based on GCS index (4-15)
Trauma diagnosis based on Injury Severity Score (ISS) between minor to severe</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Impossibility of intestinal feeding in the first 48 hours of admission
Any history of heart disease
Patients who are expected to die within 12 hours of admission to the intensive care unit.
Patients who do not have an indication for intestinal nutrition on the first day and are confirmed and predicted based on the diagnosis of the intensive care unit and will not be able to receive intestinal nutrition in the future. (Nausea, persistent vomiting, ileus, intestinal obstruction, uncontrolled diarrhea (&gt; 500 ml / day), high-output fistula (&gt; 500 ml / day), intestinal inaccessibility, incomplete resuscitation and hemodynamic instability
Patients with BMI &lt;18.5kg / m2 admitted to the intensive care unit.
Patients who receive nutritional support through complete intravenous feeding
Patients with a history of underlying disease such as diabetes, congenital and immune disorders, renal and hepatic insufficiency, and pancreatitis.
Taking anticoagulants such as heparin, warfarin, aspirin, etc.
The unwillingness of the patient or his legal guardian to participate in the project
Patients who are hospitalized in the intensive care unit for less than 48 hours
Pregnancy and lactation Severe septic shock or sepsis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>A41</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other sepsis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients receiving two 250 mg curcumin-phytosomal capsules (total of 500 mg daily) for 7 days (25 patients)</i_keyword>
      <i_keyword>Control group: Patients receiving placebo for 7 days, two 250 mg maltodextrin capsules per day (25 patients)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Inflammation. Timepoint: Before and after the intervention. Method of measurement: Measurement of inflammatory markers by serum.</prim_outcome>
      <prim_outcome>Mortality 28 days. Timepoint: Before and after the intervention. Method of measurement: Use existing statistics.</prim_outcome>
      <prim_outcome>Duration of hospitalization. Timepoint: Before and after the intervention. Method of measurement: Use of questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Change in the number of blood cells. Timepoint: Before and after the intervention. Method of measurement: Blood cell count test.</sec_outcome>
      <sec_outcome>Blood sugar changes. Timepoint: Before and after the intervention. Method of measurement: Biochemical test by enzymatic method by Hitachi 902 device.</sec_outcome>
      <sec_outcome>Serum total protein. Timepoint: Before and after the intervention. Method of measurement: Biochemical test by enzymatic method by Hitachi 902 device.</sec_outcome>
      <sec_outcome>BUN. Timepoint: Before and after the intervention. Method of measurement: Biochemical test by enzymatic method by Hitachi 902 device.</sec_outcome>
      <sec_outcome>Liver enzymes. Timepoint: Before and after the intervention. Method of measurement: Biochemical test by enzymatic method by Hitachi 902 device.</sec_outcome>
      <sec_outcome>Lactate Dehydrogenase (LDH). Timepoint: Before and after the intervention. Method of measurement: ELISA method.</sec_outcome>
      <sec_outcome>Serum albumin. Timepoint: Before and after the intervention. Method of measurement: Biochemical test by enzymatic method by Hitachi 902 device.</sec_outcome>
      <sec_outcome>Serum creatinine. Timepoint: Before and after the intervention. Method of measurement: Biochemical test by enzymatic method by Hitachi 902 device.</sec_outcome>
      <sec_outcome>NUTRIC score. Timepoint: Before and after the intervention. Method of measurement: By scoring a questionnaire including APACHE II and SOFA.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-29</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>hezarjarib isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
