<?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>IRCT20081208001497N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-26</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of licorice as an adjunctive therapy for patients with Covid-19 admitted to the intensive care unit</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of licorice as an adjunct treatment for patients with Covid-19 admitted to the intensive care unit: A randomized, placebo-controlled, double-blind clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61716</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples will be randomized by random blocking method with blocks of 4 which generated by Random Allocation software version 2. Blocking and allocation sequence for concealment will be done by the person not involved in the research (Allocation Concealment). The sample allocation ratio will be (1: 1 Allocation) and will be divided into two groups of drug recipients and placebo (Assignment). Drugs will then be given to patients based on the blocks obtained and in the order of allocation, Blinding description: This study will be performed as double-blind. The drug and placebo packing package and code allocation is done by the researcher involved in the research and then provided to the main researcher. In this way, the physician and patients will not know the contents of the packages and the type of codes and will not know which of the two control or test groups it belongs to.</study_design>
      <phase>3</phase>
      <hc_freetext>Covid-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Eligible patients receive 760 mg / day (equivalent to two tablets) d-reGliss (Iran Darok) for five days. Patients will receive other routine Covid-19 treatments according to the hospital protocol. Intervention 2: Control group: They receive the usual treatments along with placebo pills. This pill is prepared by Iran Darok Pharmaceutical Company and contains exponents such as lactose and magnesium stearate without active ingredient.</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:
Published article

When:
One year

To whom:
All people

Conditions:
No condition

Where to obtain:
Scientific responded of the study

How to obtain:
Scientific responded of the study

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sarah Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jerib avenue, Isfahan University of Medical Sciences, Faculty of pharmacy, Clinical Pharmacy D</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746 73461</zip>
        <telephone>+98 31 3792 7072</telephone>
        <email>s.mousavi@pharm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sarah Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jerib avenue, Isfahan University of Medical Sciences, Faculty of pharmacy, Clinical Pharmacy D</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746 73461</zip>
        <telephone>+98 31 3792 7072</telephone>
        <email>s.mousavi@pharm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Covid-19 diagnosis based on PCR test
Hospitalized in the intensive care unit and under mechanical ventilation</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1. Patients with high blood pressure (&lt;90/140)
Patients with congestive heart failure
Patients with severe liver, kidney and thyroid disease
Concomitant use of warfarin, SSRI, MAOI, diuretics, antiarrhythmic drugs
Treatment with antiviral drugs one month before entering the study
Allergy to licorice
Pregnancy and lactation
Dissatisfaction of the patient or his legal guardian
Infected with Covid-19 for at least 20 days prior to enrollment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>U07.1 COVID-19, virus identified</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: Eligible patients receive 760 mg / day (equivalent to two tablets) d-reGliss (Iran Darok) for five days. Patients will receive other routine Covid-19 treatments according to the hospital protocol.</i_keyword>
      <i_keyword>Control group: They receive the usual treatments along with placebo pills. This pill is prepared by Iran Darok Pharmaceutical Company and contains exponents such as lactose and magnesium stearate without active ingredient.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Average time out of intensive care unit. Timepoint: After discharge. Method of measurement: Number of hospitalization days.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Speed of recovery of Covid-19 clinical signs. Timepoint: The first and fourteenth day. Method of measurement: Percentage of improvement in symptoms.</sec_outcome>
      <sec_outcome>Duration of hospitalization in the intensive care unit. Timepoint: After discharge or death. Method of measurement: Number of days of hospitalization.</sec_outcome>
      <sec_outcome>Duration of mechanical ventilation. Timepoint: During hospitalization. Method of measurement: Number of days under mechanical ventilation.</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>2022-02-20</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan University of Medical Sciences, P.O. Box 319, Hezar-Jerib Ave. Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
