<?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>IRCT20201220049774N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-14</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of curcumin-piperine supplement  in septic patients</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of curcumin-piperine supplement on damage indicators in septic patients admitted to the intensive care unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63236</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted blocks method using the site https://www.sealedenvelope.com with the explanation that each block has 6 components. The form of the blocks can be as follows for example:
[ABAABAB], [BBABAA], [BABABA], ..... Codes A and B are randomly assigned to intervention and control groups. From all possible six blocks, the site randomly selects 11 blocks to include all the patients in the study, Blinding description: In this study, the DUE unit expert only has complete information about the type of drug received (placebo or curcumin-piperine supplement). This person plays no role in the administration, treatment evaluation, and data analysis.
According to the codes, the patients who fulfill the inclusion criteria are randomly assign to one of the groups by the DUE unit expert. The pills are then given to the researchers who are unaware of the content of the codes and the tablets type, and then prescribed. The placebo pill is very similar in appearance to the curcumin-piperine pill and contains the same ingredients except the active ingredient. Therefore, it is not possible for patients and clinical caregivers to distinguish pills from each other.</study_design>
      <phase>3</phase>
      <hc_freetext>sepsis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 33 patients will receive curcumin-piperine supplement after diagnosis of sepsis at a dose of 5.500 mg twice daily for 7 days with antibiotic regimen. Intervention 2: Control group: 33 patients will receive placebo twice a day for 7 days with antibiotic regimen.</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 I have not decided yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hesamoddin Hosseinjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Clinical Pharmacy, Faculty of Pharmacy, Ferdowsi Campus, Azadi Square, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948954</zip>
        <telephone>+98 51 3180 1586</telephone>
        <email>hosseinjanih@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hesamoddin Hosseinjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Clinical Pharmacy, Faculty of Pharmacy, Ferdowsi Campus, Azadi Square, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948954</zip>
        <telephone>+98 51 3180 1586</telephone>
        <email>hosseinjanih@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18 and 80 years
Having sepsis and being admitted to the intensive care unit
Signing an informed consent form</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy and lactation
History of allergy to turmeric and curcumin products
Age under 18 years
HIV patients
Member transplant history
Rheumatic or autoimmune disease
Patients treated with immunosuppressive drugs
Patients treated with corticosteroids
Radiotherapy
Solid or malignant tumor
Concomitant use of any supplement with antioxidant or anti-inflammatory effect or immune system regulator
Patients without oral / nasal gastrointestinal tract
White blood cell count less than 1000 / microliter</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>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 33 patients will receive curcumin-piperine supplement after diagnosis of sepsis at a dose of 5.500 mg twice daily for 7 days with antibiotic regimen.</i_keyword>
      <i_keyword>Control group: 33 patients will receive placebo twice a day for 7 days with antibiotic regimen</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum Lactate. Timepoint: At the beginning of the study and after receiving the last dose of curcumin-piperine. Method of measurement: Laboratory tests.</prim_outcome>
      <prim_outcome>C-reactive protein (CRP). Timepoint: At the beginning of the study and after receiving the last dose of curcumin-piperine. Method of measurement: Laboratory tests.</prim_outcome>
      <prim_outcome>SOFA score(Sequential  organ failure assessment). Timepoint: At the beginning of the study and after receiving the last dose of curcumin-piperine. Method of measurement: Laboratory tests.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Serum creatinine. Timepoint: At the beginning of the study and after receiving the last dose of curcumin-piperine. Method of measurement: Laboratory tests.</sec_outcome>
      <sec_outcome>WBC count. Timepoint: At the beginning of the study and after receiving the last dose of curcumin-piperine. Method of measurement: Laboratory tests.</sec_outcome>
      <sec_outcome>Platelet count. Timepoint: At the beginning of the study and after receiving the last dose of curcumin-piperine. Method of measurement: Laboratory tests.</sec_outcome>
      <sec_outcome>Neutrophil to lymphocyte ratio. Timepoint: At the beginning of the study and after receiving the last dose of curcumin-piperine. Method of measurement: Laboratory tests.</sec_outcome>
      <sec_outcome>Lymphocyte to monocyte ratio. Timepoint: At the beginning of the study and after receiving the last dose of curcumin-piperine. Method of measurement: Laboratory tests.</sec_outcome>
      <sec_outcome>Platelet to lymphocyte ratio. Timepoint: At the beginning of the study and after receiving the last dose of curcumin-piperine. Method of measurement: Laboratory tests.</sec_outcome>
      <sec_outcome>Total Bilirubin. Timepoint: At the beginning of the study and after receiving the last dose of curcumin-piperine. Method of measurement: Laboratory tests.</sec_outcome>
      <sec_outcome>Direct Bilirubin. Timepoint: At the beginning of the study and after receiving the last dose of curcumin-piperine. Method of measurement: Laboratory tests.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-09</approval_date>
        <contact_name>Research Ethice Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Department of Clinical Pharmacy, Faculty of Pharmacy, Ferdowsi Campus, Azadi Square, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
