<?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>IRCT20160313027033N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-16</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>The effect of MCT Oil on COVID-19</public_title>
      <acronym>MCT</acronym>
      <scientific_title>Evaluation of the effect of oral intermediate chain triglyceride on prognosis and course of disease in suspected outpatients with COVID-19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46762</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly divided into intervention and control groups using Random Allocation Software.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Coronavirus COVID-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in this group in addition to drug treatment according to the Ministry of Health protocol, take 2 tablespoons of medium-chain triglyceride (MCT) to cure fever with each meal. Both group are thought to take the following advice base on traditional medicine instructions:During this period, avoid consuming carbohydrate including sweet and eat less starch food.skim snacks and start eating when they're starving.avoid eating before satiating.eat slowly and chew well.walk for 15 minutes after eating. Intervention 2: Control group: Patients in this group receive medication according to the Ministry of Health protocol. Both group are thought to take the following advice base on traditional medicine instructions:During this period, avoid consuming carbohydrate including sweet and eat less starch food.skim snacks and start eating when they're starving.avoid eating before satiating.eat slowly and chew well.walk for 15 minutes after eating.</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 will be shared through a supplementary file after unidentified individuals.

When:
Start the access period from 6 months after printing results

To whom:
Researchers and other people can access data if they need it.

Conditions:
For use in review articles, reprogramming and modeling can be used in other studies. In case of need, should be emailed to the programmer.

Where to obtain:
Executor of plan or University

How to obtain:
Email the scheduler (Dr.Setayesh) ,he answers.

Comments:
All information is available to others for the advancement of science.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza Zahedi Neyestani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Crossroad Amirkabir, Jomhuri eslami Blvd</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5856</telephone>
        <email>ali.zahedi@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Setayesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Crossroad Amirkabir, Jomhuri eslami Blvd</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618843883</zip>
        <telephone>+98 34 3211 0860</telephone>
        <email>msetayeshmail@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with mild or moderate COVID-19 disease according to the diagnostic protocol provided by the Ministry of Health</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>No allergic to MCT (for those who have previously taken MCT and know they are allergic).</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19</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: Patients in this group in addition to drug treatment according to the Ministry of Health protocol, take 2 tablespoons of medium-chain triglyceride (MCT) to cure fever with each meal. Both group are thought to take the following advice base on traditional medicine instructions:During this period, avoid consuming carbohydrate including sweet and eat less starch food.skim snacks and start eating when they're starving.avoid eating before satiating.eat slowly and chew well.walk for 15 minutes after eating.</i_keyword>
      <i_keyword>Control group: Patients in this group receive medication according to the Ministry of Health protocol. Both group are thought to take the following advice base on traditional medicine instructions:During this period, avoid consuming carbohydrate including sweet and eat less starch food.skim snacks and start eating when they're starving.avoid eating before satiating.eat slowly and chew well.walk for 15 minutes after eating.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Temperature. Timepoint: 0-1-2-3-14 days after starting intervention. Method of measurement: Thermometer.</prim_outcome>
      <prim_outcome>Cough (severity-frequency). Timepoint: 0-1-2-3-14 days after starting intervention. Method of measurement: Fisman Cough Severity Score.</prim_outcome>
      <prim_outcome>Weakness. Timepoint: 0-1-2-3-14 days after starting intervention. Method of measurement: Asking patients using visual analog scale (VAS).</prim_outcome>
      <prim_outcome>Respiratory rate. Timepoint: 0-1-2-3-14 days after starting intervention. Method of measurement: Counting the number of breaths per minute.</prim_outcome>
      <prim_outcome>Muscular pain. Timepoint: 0-1-2-3-14 days after starting intervention. Method of measurement: Asking patients using visual analog scale (VAS).</prim_outcome>
      <prim_outcome>Urine Ketone. Timepoint: Four hours after taking MCT oil. Method of measurement: It is checked with a urine test strip.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hospital admssion. Timepoint: 0-1-2-3-14 days after starting intervention. Method of measurement: Ratio of the number of admission to total patients in each group.</sec_outcome>
      <sec_outcome>Mortality. Timepoint: 0-1-2-3-14 days after starting intervention. Method of measurement: Ratio of the number of deaths to total patients in each group.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-24</approval_date>
        <contact_name>Ethics committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Beginning of Ibn Sina Street, Beginning of Jihad Blvd., Somayeh Road (Tahmasebabad), Kerman Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
