<?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>IRCT20121216011763N46</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-04</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of curcumin-piperine in patients with coronavirus (COVID-19)</public_title>
      <acronym></acronym>
      <scientific_title>Effect of curcumin-piperine supplementation on disease duration, severity and clinical signs, and inflammatory factors in patients with coronavirus (COVID-19): A randomized, double-blind, placebo-controlled clinical trial study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47529</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomly, based on the permuted block randomization method, using blocks of 4 that will be blocked based on gender variables and will be assigned to one of two curcumin-piperine and placebo groups. The enrolling participants, and assigning participants to the groups will be carried out by a trained nutritionist. Researchers will not be informed about the randomization process until the completion of data analyses, Blinding description: This study is a double-blind clinical trial (participant, researcher). The curcumin-piperine supplement and its placebo will be packaged in similar boxes, and the researcher and patients will not be informed of the contents of the packs until the end of the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>coronavirus (covid-19) disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Two curcumin-piperine capsules (500 mg of curcumin + 5 mg of piperine) will be given daily for 2 weeks after lunch and dinner. Intervention 2: Control group: 2 placebo capsules ( containing 505 mg of maltodextrin) will be given daily after lunch and dinner for 2 weeks.</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:
The collected deidentified for the primary outcome measure only will be shared.

When:
12 months after publication

To whom:
Available for people working in academic institutions

Conditions:
To conduct similar studies

Where to obtain:
askari@mui.ac.ir

How to obtain:
The data will send as soon as possible, after receiving the request.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Gholamreza Askari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezarjarib Ave</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3668 1378</telephone>
        <email>askari@mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Gholamreza Askari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezarjarib Ave</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 1792 2110</telephone>
        <email>askari@mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Tendency to participate in the study
People aged 18-65 years
Diagnosis of Covid-19 based on the PCR test</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Age less than 20 and more than 75 years
Taking warfarin
Sensitivity to herbal products such as turmeric and pepper</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.02</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19 Disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Two curcumin-piperine capsules (500 mg of curcumin + 5 mg of piperine) will be given daily for 2 weeks after lunch and dinner.</i_keyword>
      <i_keyword>Control group: 2 placebo capsules ( containing 505 mg of maltodextrin) will be given daily after lunch and dinner for 2 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>CT of the chest. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: Find out - Photos - CT.</prim_outcome>
      <prim_outcome>Body temperature. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: By using clinical thermometer.</prim_outcome>
      <prim_outcome>Duration of hospitalization. Timepoint: At the time of discharge from the hospital. Method of measurement: By Using the patient's medical record.</prim_outcome>
      <prim_outcome>Hs-CRP. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: Enzymatic method.</prim_outcome>
      <prim_outcome>ESR. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: Enzymatic method.</prim_outcome>
      <prim_outcome>ALT. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: Enzymatic photometric method.</prim_outcome>
      <prim_outcome>AST. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: Enzymatic photometric method.</prim_outcome>
      <prim_outcome>LDH. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: Enzymatic photometric method.</prim_outcome>
      <prim_outcome>BUN. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: urine sample.</prim_outcome>
      <prim_outcome>Creatinine. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: by laboratory kit.</prim_outcome>
      <prim_outcome>CBC. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: blood sample.</prim_outcome>
      <prim_outcome>Blood oxidative stress indices ( SOD, MDA, TAC). Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: By using available commercial kits.</prim_outcome>
      <prim_outcome>Albumin. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: blood sample.</prim_outcome>
      <prim_outcome>Severity of the disease. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: By using clinical and laboratory evaluations.</prim_outcome>
      <prim_outcome>Severity and number of coughs. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: Visual analogue scales (VAS) for cough.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-18</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezarjarib Ave., Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
