<?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>IRCT20200411047016N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-31</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Stopcivir syrup in patients with COVID-19</public_title>
      <acronym>Stopcivir syrup</acronym>
      <scientific_title>Evaluating efficacy and safety of Stopcivir (Zataria multiflora Boiss+ Alium Sativum+ Heracleum persicum+ Satureja hortensis+ Dianthus+ Foeniculum vulgare+ opium) syrup on length of hospitalization in patients with COVID-19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47044</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be by blocking randomization (quadruple random blocks). Which is provided by statistical software. Randomization units are individuals. 150 outpatients referred to the hospital emergency department are randomly assigned to one of the two intervention and control groups. This study is a two-course method and patients in the intervention group will receive the intervention drug in addition to the routine treatment, but in the patient control group, they will receive the placebo along with the routine treatment, Blinding description: To blind the study, the drugs are packaged with special tags with double-digit codes so that only the final evaluator, who is a physician, is aware of the type of medication that patients are receiving. Also, in order not to inform the patient, the placebo is given to the control group. Therefore, patients are not aware of the type of medication they are receiving.</study_design>
      <phase>3</phase>
      <hc_freetext>COVID- 19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this study, the content of specific ratios of garlic, Lamiaceae,  Heracleum persicum, Dianthus, Satureja hortensis plus a little opium in an alcohol-based solvent will be prepared and used as an adjunctive or concomitant medication alongside other routine medicine to treat patients with covid 19. Both groups will receive standard treatment. The dosage of the syrup for the first two days is 10 cc every 4 hours and the next two days is 10 cc every 6 hours, which is given to the patient by the ward nurse and is monitored. Intervention 2: Control group: The other group receives the placebo.</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 There is no further information at this time.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyedeh Sedigheh Yousefi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Touba Clinic; Khazar Boulevard; Khazar Square</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>48168-95474</zip>
        <telephone>+98 11 3324 4893</telephone>
        <email>s.yousefi@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyde Sedighe Yousefi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Touba Clinic; Khazar Boulevard; Khazar Square</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>48168-95474</zip>
        <telephone>+98 11 3324 4893</telephone>
        <email>s.yousefi@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The definitive case of covid 19 based on laboratory confirmation
Diagnosis of covid 19 based on CT or chest radiography
Patients between 18-75 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The presence of comorbidities (sever renal failure, sever liver failure, CHF, major cerebrovascular and cardiovascular disease, chronic lung disease, malignancy, immune system diseases including AIDS, encephalopathy)
Pregnancy and lactation
History of allergies to herbal drugs
Crisis and severe cases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B34.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Coronavirus infection, unspecified</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 study, the content of specific ratios of garlic, Lamiaceae,  Heracleum persicum, Dianthus, Satureja hortensis plus a little opium in an alcohol-based solvent will be prepared and used as an adjunctive or concomitant medication alongside other routine medicine to treat patients with covid 19. Both groups will receive standard treatment. The dosage of the syrup for the first two days is 10 cc every 4 hours and the next two days is 10 cc every 6 hours, which is given to the patient by the ward nurse and is monitored.</i_keyword>
      <i_keyword>Control group: The other group receives the placebo.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Length of hospitalization. Timepoint: Hospitalization time and Hospital discharge time. Method of measurement: Check List.</prim_outcome>
      <prim_outcome>Shortness of breath. Timepoint: Variable will be completed in the form of a checklist at the beginning of the Hospitalization and daily until the end of hospitalization. Method of measurement: Check list.</prim_outcome>
      <prim_outcome>Oxygen saturation. Timepoint: Variable will be completed in the form of a checklist at the beginning of the Hospitalization and daily until the end of hospitalization. Method of measurement: Check list.</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>Mazandaran 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 Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Deputy of Research and Technology of Mazandaran University of Medical Sciences, Teacher Street, Teacher's Square Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
