<?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>IRCT20200405046960N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-08</date_registration>
      <primary_sponsor>Ardabil University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of Kelofan syrup on COVID-19</public_title>
      <acronym>-</acronym>
      <scientific_title>Evaluating efficacy of Kelofan syrup, a traditional Iranian medicine product, on pulmonary and other clinical and laboratory manifestations of patients with probable or confirmed COVID-19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>15</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46961</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Condition 1: COVID-19. Condition 2: COVID-19.</hc_freetext>
      <i_freetext>In the intervention group, in addition to the standard treatment, medicinal herbal products will be prescribed. The drug will be given in syrup form. The syrup will contain the following medicinal herbs: Nepeta bracteata،  Adiantum capillus veneris،  Glycyrrhi za glabra, Foeniculum vulgare، Viola odorata,  Ziziphus jujube,  Malva sylvestris, Nigella sativa . The intervention group will receive 7.5 cc of Kelofan syrup every 12 hours for one week..</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ramin Nasimi Doost Azgomi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ardabil University of Medical Sciences; Daneshgah street</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5618985991</zip>
        <telephone>+98 45 3142 2529</telephone>
        <email>modir7060@yahoo.com</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ramin Nasimi Doost Azgomi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ardabil University of Medical Sciences; Daneshgah street</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5618985991</zip>
        <telephone>+98 45 3142 2529</telephone>
        <email>Modir7060@yahoo.com</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients over 18 years old
Hospitalized patients with probable or confirmed COVID-19 based on radiological findings or positive PCR test according to the instructions of the Ministry of Health
Clinically classified as moderate and severe, no need for intubation
Written and informed satisfaction of patients</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Liver, kidney and heart failure
History of allergies to medicinal herbs
Immunodeficiency
Hypertension
Diabetes
Alcohol or drug addiction
Patients with transplanted organs
Cor Pulmonel Patients
Taking anticoagulants, antiarrhythmics, antihypertensives, corticosteroids and immunosuppressants
Pregnancy
Breast feeding</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
      <hc_code>U07.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID19, virus identified</hc_keyword>
      <hc_keyword>COVID19, virus not identified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, in addition to the standard treatment, medicinal herbal products will be prescribed. The drug will be given in syrup form. The syrup will contain the following medicinal herbs: Nepeta bracteata،  Adiantum capillus veneris،  Glycyrrhi za glabra, Foeniculum vulgare، Viola odorata,  Ziziphus jujube,  Malva sylvestris, Nigella sativa . The intervention group will receive 7.5 cc of Kelofan syrup every 12 hours for one week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Oxygen saturation. Timepoint: Clinical examination and Pulse Oximetry before starting medication and regularly during treatment. Method of measurement: Pulse Oximeter.</prim_outcome>
      <prim_outcome>Respiratory Rate. Timepoint: Clinical examination before starting medication and regularly during treatment. Method of measurement: Respiratory Count.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>C-reactive protein. Timepoint: Intravenous blood testing before starting medication and during treatment. Method of measurement: Venous blood test.</sec_outcome>
      <sec_outcome>Lymphocytes. Timepoint: Intravenous blood testing before starting medication and during treatment. Method of measurement: Venous blood test.</sec_outcome>
      <sec_outcome>White Cell blood count. Timepoint: Intravenous blood testing before starting medication and during treatment. Method of measurement: Venous blood test.</sec_outcome>
      <sec_outcome>Liver enzymes. Timepoint: Intravenous blood testing before starting medication and during treatment. Method of measurement: Venous blood test.</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>Ardabil University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-05</approval_date>
        <contact_name>Ethics committee of Ardabil University of Medical Sciences</contact_name>
        <contact_address>Ardabil University of Medical Sciences; Daneshgah street Ardabil Ardabil Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
