<?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>IRCT20150613022681N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-02</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of curcumin piperine supplementation in patients with sepsis admitted to the intensive care unit (ICU): a double-blind randomized controlled clinical trial</public_title>
      <acronym></acronym>
      <scientific_title>The effect of curcumin piperine supplementation on inflammation, length of stay, and 28-day mortality in patients with sepsis admitted to the intensive care unit (ICU): a double-blind randomized controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52661</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: Randomization will be conducted using the block randomization method (permuted blocked randomization). depending on the sample size, each block includes 4 characters and will be used AABB combination. In the following, all possible modes from the combination will be listed and a code will be allocated to each patient.
This will be done using a random number table, Blinding description: To blind both patients and investigators, in the beginning, cans containing curcumin supplement and placebo were coded as A and B by a person other than the researcher to ensure the researcher and participants were not informed about the types of supplement received by participants.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Sepsis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients receiving two 500 mg capsules of curcumin-piperine per day for 7 days (total 1000 mg of curcumin per day and 10 mg of piperine per day) (33 patients). Intervention 2: Control group: Intervention group: Patients receiving 2 placebo capsules for each day containing 500 mg of maltodextrin per day (total 1000 mg of maltodextrin) (33 patients) for 7 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data can be shared at the request of individuals

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
alikiaiib@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>Babak Alikiaii</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>alikiaiib@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Babak Alikiaii</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>alikiaiib@med.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 20-75 years
Gastrointestinal tract with normal function and intestinal nutrition criteria
Diagnosis of sepsis is based on blood culture and the approval of an ICU, anesthesiologist and infectious disease specialist</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Impossibility of intestinal feeding in the first 48 hours of admission
Any history of underlying heart disease
Patients who are hospitalized in the intensive care unit for less than 48 hours
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 that they will not be able to receive intestinal nutrition in the future. (Nausea, persistent vomiting, ileus, intestinal obstruction, uncontrolled diarrhea (&gt; 500 ml per day), high-output fistula (&gt; 500 ml per day), intestinal inaccessibility, incomplete resuscitation and hemodynamic
Patients with BMI &lt;18.5 kg / 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 uncontrolled diabetes, congenital and immune disorders, renal and hepatic insufficiency, and pancreatitis.
Taking anticoagulants such as heparin, warfarin, aspirin, etc.
Pregnancy and lactation
Severe septic shock or sepsis
Dissatisfaction of the patient or her legal guardian</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 500 mg capsules of curcumin-piperine per day for 7 days (total 1000 mg of curcumin per day and 10 mg of piperine per day) (33 patients)</i_keyword>
      <i_keyword>Control group: Intervention group: Patients receiving 2 placebo capsules for each day containing 500 mg of maltodextrin per day (total 1000 mg of maltodextrin) (33 patients) for 7 days</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Inflammation (via hs-CRP, Albumin, pre Albumin indices). 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 official 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 red blood cells. Timepoint: Before and after the intervention. Method of measurement: Device analysis using cell counter device (hematology analyzer).</sec_outcome>
      <sec_outcome>Serum concentration of lipid profiles including triglyceride, cholesterol, HDL, LDL. Timepoint: Before and after the intervention. Method of measurement: Biochemical test by enzymatic method by Hitachi 902 device.</sec_outcome>
      <sec_outcome>Fasting Blood Sugar Concentration. 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>Blood prolactin. 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>
    </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>Isfahan University of Medical Sciences, Hezar Jerib street, Esfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
