<?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>IRCT20160316027081N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-31</date_registration>
      <primary_sponsor>Artesh University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Licorice in COVID-19</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of Standard Treatment with Standard Treatment plus licorice extract as adjunctive treatment in Improving Respiratory Symptoms and Survival Rate in COVID-19 Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>190</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46678</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, we use a permuted four-block randomization method. For this purpose six blocks consisting of AABB, ABAB, ABBA, BBAA, BABA, and BAAB are designated and then for each of four patients, one of these blocks will be assigned using the random digit table. In fact, according to the order specified in each block, two patients will receive protocol A (standard treatment of COVID) and two patients will receive protocol B (standard treatment of COVID plus licorice extract).</study_design>
      <phase>2</phase>
      <hc_freetext>COVID-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group of patients with COVID-19, in addition to standard treatment introduced by the Ministry of Health, the second drug is also prescribed. It is a licorice-based herbal extract that contains licorice, Rheum palmatum, Rosa damascene, Crocus sativus, and Ziziphus jujube. In order to prepare this extract, simple substances of these herbal are first prepared from the pharmaceutical market and after identification in the herbarium of the Faculty of Pharmacy of Tehran University of Medical Sciences, a herbarium code is assigned to each one. Then, a herbal syrup is extracted from these herbs by the maceration method. The syrup is standardized based on glycerol content, the total phenolic, and flavonoids compounds by HPLC method. Microbial controls are performed on the syrup. The syrup is packaged in 240 cc dark pets and given to the patient and at a dose of 10 cc every 8 hours for up to 8 days. Intervention 2: Control group: Patients in this group receive only standard treatment provided by the Ministry of Health for COVID-9.</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:
Questionnaire

When:
After one year

To whom:
Deputy of research, Ministry of health

Conditions:
After formal request

Where to obtain:
AJA University of medical sciences, deputy of research

How to obtain:
From:
Ministry of Health, Deputy of Research
To:
AJA University of Medical Sciences

Comments:
We are not permitted to publish the information of the military patients unprepared.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Saeed Soleiman Meigooni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 29, 1th Niloufar, Sarv Av, east Farsad, St, Javanmardan Bolv, Shahr-e-Ziba</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1487784637</zip>
        <telephone>+98 21 4414 4939</telephone>
        <email>dr.saeed.meigooni@gmail.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Saeed Soleiman-Meigooni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 29, 1th Niloufar Alley, Sarv Av, east Farsad St, Javanmardan Blvd, Shahr e Ziba</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1487784637</zip>
        <telephone>+98 21 4414 4939</telephone>
        <email>Dr.saeed.meigooni@gmail.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Admitted patients with COVID-19 in the four hospitals of AJA medical University in Tehran
COVID-19 diagnosed by lung CT or naso-pharyngeal PCR</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Severe hypersensitivity to the Licorice
DKA or NKHC
Pregnancy
Decompensated Cirrhosis
Non viral sepsis
Active GIB
Acute trauma or Surgical problem
Unstable angina or Acute MI
Chronic renal failure with Uremic symptoms</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19, virus identified</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: In this group of patients with COVID-19, in addition to standard treatment introduced by the Ministry of Health, the second drug is also prescribed. It is a licorice-based herbal extract that contains licorice, Rheum palmatum, Rosa damascene, Crocus sativus, and Ziziphus jujube. In order to prepare this extract, simple substances of these herbal are first prepared from the pharmaceutical market and after identification in the herbarium of the Faculty of Pharmacy of Tehran University of Medical Sciences, a herbarium code is assigned to each one. Then, a herbal syrup is extracted from these herbs by the maceration method. The syrup is standardized based on glycerol content, the total phenolic, and flavonoids compounds by HPLC method. Microbial controls are performed on the syrup. The syrup is packaged in 240 cc dark pets and given to the patient and at a dose of 10 cc every 8 hours for up to 8 days.</i_keyword>
      <i_keyword>Control group: Patients in this group receive only standard treatment provided by the Ministry of Health for COVID-9.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Admission time. Timepoint: Daily. Method of measurement: Patients' profile (Yes or no).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>C-reactive protein. Timepoint: On admission, On discharge. Method of measurement: Laboratory test.</sec_outcome>
      <sec_outcome>Differences in lymphocyte count. Timepoint: on admission, on discharge. Method of measurement: with the cell counter device.</sec_outcome>
      <sec_outcome>The death number. Timepoint: at the end of admission. Method of measurement: base on the patient registries.</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>Artesh University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-18</approval_date>
        <contact_name>Ethics committee of AJA University of Medical Sciences</contact_name>
        <contact_address>No 29, 1th Niloufar Ave, Sarv St, East Farsad St, avanmardan Blvd, Shahre Ziba Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
