<?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>IRCT20220830055834N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-25</date_registration>
      <primary_sponsor>Khoram-Abad University of Medical Sciences</primary_sponsor>
      <public_title>Clinical trial for a herbal syrup (named Hero) in reduction of COVID 19 respiratory infection</public_title>
      <acronym></acronym>
      <scientific_title>Clinical trials of a syrup from three medicinal plants with effective  index glycyrrhizin index in reducing inflammation, cough, and duration of hospitalization caused by Covid-19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>82</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66748</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Two groups are different by the severity of infection, Blinding description: Drug or placebo would be prepared in Khorramabad City and after labelling with a code number and A or B group would be recorded by Secretary of Research of the Lorestan University of(LUMS) and the code would be stored in his safe in his office. The bottles of drugs and placebo  are all would be similar in all aspects except number of labels. The bottles then would be send to Yasuj City for Clinical trials.  Assignment of recipient of drugs or placebo would be based on Stratified Random Allocation method. This would be based on severity of infection(mild or moderate) , age and sex(8 groups ). In each group there would be random permuted block method for allocation of participants. At the end the data would be analyzed in 2 groups (A and B) by the Biostatistician and the decoder would open the labels for conclusion of the results.</study_design>
      <phase>1</phase>
      <hc_freetext>Respiratory Infection of COVID-19.</hc_freetext>
      <i_freetext>Intervention 1: Control group: The routine treatment would be given to this group as well as Placebo which would look and taste like the Hero Syrup. Intervention 2: Intervention group: There would be a routine treatment for this group  as well as the Hero  Syrup  which would be given according to the protocol for 7 days (3 times a day with 350 milligrams/mili liter).</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Confidentiality of patients</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Gholam Reza Talei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kamalvand, Pardis Lorestan University of Medical Sciences,</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6815144311</zip>
        <telephone>+63 3120175</telephone>
        <email>taleireza@gmail.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Doctor. Gholam Reza Talei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kamalvand, Pardis , Lorestan University of Medical Sciences</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6815144311</zip>
        <telephone>009866133120133</telephone>
        <email>taleireza@yahoo.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18 to 65 years old
Proven infection with COVID - 19
Ability (mental and physical ) to use the drug syrup
Lack of hypersensitivity to the drug and similar compounds.
Ability to respond to contact and interview about the effectiveness of the drug.
patient must have not be hospitalized in the ICU ward.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Negative criteria for COVID-19 infection</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19: confirmed by laboratory testing</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>Control group: The routine treatment would be given to this group as well as Placebo which would look and taste like the Hero Syrup.</i_keyword>
      <i_keyword>Intervention group: There would be a routine treatment for this group  as well as the Hero  Syrup  which would be given according to the protocol for 7 days (3 times a day with 350 milligrams/mili liter)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pressure of Oxygen in the blood. Timepoint: At the admission time and every hour for the first 12 hours, depending on the severity of symptoms every 1 hour. then twice a day  up to the end of the trial. Method of measurement: Oxymeter for blood oxygen.</prim_outcome>
      <prim_outcome>Shortness of breath. Timepoint: At the admission time and every hour for the first 12 hours, depending on the severity of symptoms every 1 hour. then twice a day  up to the end of the trial. Method of measurement: observation for shortage of breath.</prim_outcome>
      <prim_outcome>Fever. Timepoint: At the admission time and every hour for the first 12 hours, depending on the severity of symptoms every 1 hour. then twice a day  up to the end of the trial. Method of measurement: Thermometer for fever.</prim_outcome>
      <prim_outcome>Cough. Timepoint: At the admission time and every hour for the first 12 hours, depending on the severity of symptoms every 1 hour. then twice a day  up to the end of the trial. Method of measurement: observation of cough.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The death rate would be compared in 2 groups of test and control. In the test group, they received Hero Syrup and routine treatment, and in the control group, they received only routine treatment. Timepoint: At the end of 14 days of infection period. Method of measurement: Counting the  death of patients  in 2 groups according to the hospital report and comparing it.</sec_outcome>
      <sec_outcome>Counting the patients who were hospitalized in the ICU and the duration of their hospitalization in that ward. Timepoint: from the beginning of the symptoms for 14 days, if the patient needed ICU, the duration of hospitalization in the ward would be recorded according to the hospital record. Method of measurement: Counting the days of hospitalization in the ICU ward according to the hospital record.</sec_outcome>
      <sec_outcome>Patients who needed Ventilators during the 14 days of clinical COVID-19 infection would be followed, counted, and compared. Timepoint: At the end of 14 days of COVID-19 infection, those patients who needed Ventilators would be followed counted, and compared. Method of measurement: Patients who needed the use of Ventilation would be counted and compared in these 2 groups.</sec_outcome>
      <sec_outcome>Day(s) of hospitalization in ICU ward, if necessary, would bge compared in two groups. Timepoint: from the beginning of the symptoms for 14 days, if the patient needed ICU, the duration of hospitalization in the ward would be recorded according to the hospital record and compared in the 2 groups. Method of measurement: Counting the days of hospitalization in the ICU ward according to the hospital record and would be compared.</sec_outcome>
      <sec_outcome>Patients who needed a Ventilator during the 14 days of clinical COVID 19 infection would be followed and days of this requirement would be compared in two groups. Timepoint: At the end of 14 days of COVID-19 infection. Method of measurement: At the end of 14 days of COVID-19 infection, days of used Ventilators by patients would be  counted and compared.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Yasouj University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Khoram-Abad University of Medical Sciences</source_name>
      <source_name>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-12</approval_date>
        <contact_name>Research Ethic Committee of Lorestan University of Medical Sciences</contact_name>
        <contact_address>Kamalvand Khorramabad Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
