<?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>IRCT20130722014106N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-30</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>Effect of oral syrup and intranasal spray of Falcaria Vulgaris plant in patients with Covid-19</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of oral syrup and intranasal spray of Falcaria Vulgaris plant on patients with Covid-19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56977</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using random blocking method (Block Randomization ) with 4 blocks and a ratio of 1: 1 are allocated to the treatment and control groups. (For 4 blocks there will be six different modes:  1.TTCC  2.TCTC  3.TCCT 4.CCTT  5.CTTC 6.CTCT).
Random numbers will be created with the help of a computer and a statistics consultant. For numbers between 0 and 1.6, combination 1 (TTCC), numbers between 1.6 and 2.6, combination 2 (TCTC), etc. are divided into two groups of 50 people. Patients based on randomized block allocation method classified according to age range (20 years and later) and gender (male, female) in two groups with 50 people (25 males and 25 females) with Herbal medicine treatment (treatment) and routine treatment (control), Blinding description: Herbal medicine and placebo packaging is prepared with a label with code B or A. Other specifications on the labels are the same. Physicians, nurses, patients, data collectors, and those evaluating the outcome are unaware of the drug and placebo group. Patients are aware that they are in either the herbal group or the placebo group, but they do not know the type of group they are in.</study_design>
      <phase>3</phase>
      <hc_freetext>COVID-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in this group, in addition to receiving standard medications, use a syrup or nasal spray prepared from the mountain ghaziani plant, which is dried under normal conditions and prepared as a syrup and nasal spray three times a day for a week. Intervention 2: Control group: Routine treatment according to the latest update of the new national coronavirus treatment guidelines.</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:
The main consequences are shared after the intervention in the disease

When:
One year after the publication of the results

To whom:
Researchers, doctors and students

Conditions:
For the use of other researchers

Where to obtain:
Correspond with the project manager.
Phone: 08337272049
Email: hossein.amirii@yahoo.com

How to obtain:
Request via email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hossein Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Naghlieh Street - Imam Khomeini Hospital, Kermanshah</address>
        <city>kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6718743161</zip>
        <telephone>008337272049</telephone>
        <email>hossein.amirii@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Naghlieh Street - Imam Khomeini Hospital, Kermanshah</address>
        <city>kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6718743161</zip>
        <telephone>008337272049</telephone>
        <email>hossein.amirii@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Confirmation of coronavirus infection by CT scan of the chest and PCR test
Age 20 to 70 years
Willingness to cooperate in the study and completion of informed written consent</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>pregnant women
children
Elderly (people over 70)
People who use mechanical ventilation
People undergoing chemotherapy
People who receive corticosteroids are excluded from the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>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: Patients in this group, in addition to receiving standard medications, use a syrup or nasal spray prepared from the mountain ghaziani plant, which is dried under normal conditions and prepared as a syrup and nasal spray three times a day for a week.</i_keyword>
      <i_keyword>Control group: Routine treatment according to the latest update of the new national coronavirus treatment guidelines</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood oxygen saturation. Timepoint: At the beginning and end of the study on a regular basis. Method of measurement: Pulse oximeter.</prim_outcome>
      <prim_outcome>Rate of lung involvement. Timepoint: beginning and end of the study. Method of measurement: computed tomography scan.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Number of breaths. Timepoint: At the beginning and end of the study on a regular basis. Method of measurement: Counting breaths per minute.</sec_outcome>
      <sec_outcome>Body temperature. Timepoint: At the beginning and end of the study on a regular basis. Method of measurement: thermometer and clinical examination.</sec_outcome>
      <sec_outcome>Dyspnea. Timepoint: At the beginning and end of the study on a regular basis. Method of measurement: clinical examination.</sec_outcome>
      <sec_outcome>Cough. Timepoint: At the beginning and end of the study on a regular basis. Method of measurement: clinical examination.</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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-19</approval_date>
        <contact_name>Ethics committee of Kermanshah University of Medical Science</contact_name>
        <contact_address>Central building, Beheshti Blvd, Kermanshah University of Medical Science Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
