<?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>IRCT20160131026298N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-23</date_registration>
      <primary_sponsor>Dina Pharmed Exir Salamat Co</primary_sponsor>
      <public_title>Evaluation of the effect of SINA anti-flu natural product on COVID-19</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of SINA anti-flu syrup and drop on respiratory quality in COVID-19 ; A double-blind study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49886</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method will be  blocked randomization (Blocks of size 4). Randomization units are individuals. Eighty outpatients referred to the hospital emergency department are randomly assigned to one of the two intervention and control groups according to  form of random string produced by online random allocation , Blinding description: Study participants, the clinical observer, the data collector, and the data analyzer are kept blind to the study groups. Blinding will be done using a placebo in the control group.</study_design>
      <phase>2-3</phase>
      <hc_freetext>COVID-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The product includes herbal syrup (Echinacea, thyme, hyssop, Chebulic Myrobaan), honey and glycyrrhizin drop.Dosage of syrup: every 6 hours;10 cc. Dosage of drop: 20 drops after lunch and dinner. In the intervention group, conventional medicine is used according to the latest protocol of the Ministry of Health at the begining of the study (Azithromycin 250mg once a day and naproxen 250mg twice a day). Intervention 2: Control group: In this group, the common drug is used according to the latest protocol of the Ministry of Health at the begining of the study that is similar to the common drug medicine in the herbal product group.</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 Pay attention to organizational rules</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Hasanzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kamal Shahr, next to Baharestan Industrial town, Medicinal Plants Science and Technology Park, postal code1314744513</address>
        <city>Kamalshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1314744513</zip>
        <telephone>+98 912 332 2848</telephone>
        <email>reza.hasanzade7@gmail.com</email>
        <affiliation>Dina Pharmed Exir Salamat Co</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ahmad Reza Sharifi Olounabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vice-Chancellor for Research and Technology, Third Floor, Baqiyatallah University, Sheikh Bahaei St, Mulla Sadra St, Vanak Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 8755 5250</telephone>
        <email>a-sharifi@bmsu.ac.ir</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Male or female patients 18 years old and older with COVID-19
positive coronavirus 19 PCR Ground glass view at low-dose CT scan
Arterial oxygen saturation less than 93%
Consciously completed consent form completed by the patient or the patient's supervisor</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of pulmonary malignancy
History of asthma or COPD
History of Disabling disease or malignancy
Liver or kidney disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>U07.2 COVID-19, virus not identified, 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: The product includes herbal syrup (Echinacea, thyme, hyssop, Chebulic Myrobaan), honey and glycyrrhizin drop.Dosage of syrup: every 6 hours;10 cc. Dosage of drop: 20 drops after lunch and dinner. In the intervention group, conventional medicine is used according to the latest protocol of the Ministry of Health at the begining of the study (Azithromycin 250mg once a day and naproxen 250mg twice a day).</i_keyword>
      <i_keyword>Control group: In this group, the common drug is used according to the latest protocol of the Ministry of Health at the begining of the study that is similar to the common drug medicine in the herbal product group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Measurement of cough severity. Timepoint: Day 1 before and at the end of treatment. Method of measurement: Standard cough questionnaire.</prim_outcome>
      <prim_outcome>Severity of shortness of breath. Timepoint: Day 1 before and at the end of treatment. Method of measurement: Shortness Of Breath With Daily Activity (SOBDA) Questionnaire.</prim_outcome>
      <prim_outcome>Lung radiologic changes. Timepoint: At beginning and end of the study. Method of measurement: Chest CT scan.</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>Dina Pharmed Exir Salamat Co</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-29</approval_date>
        <contact_name>Ethics Committee of Baqiyatallah University of Medical Sciences</contact_name>
        <contact_address>Baqiyatallah University of Medical Sciences, Shahid Nosrati Alley, Shaikh Bahai St., Vanak Square, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
