<?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>IRCT20081011001323N25</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-17</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy  of  extract of  of Zingiber  cinnamomum  and  zataria multiflora    in covid-19 disease</public_title>
      <acronym></acronym>
      <scientific_title>Comparison  Efficacy  of  extract  plants of Zingiber , cinnamon , zataria multiflora with standard protocol in treatment and clinical improvement of patients with moderate to severe symptoms of covid-19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47935</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are allocated randomly with simple random allocation method by use of random number table to one of each group (combined herbal extract or standard protocol) and received the intervention of that group.</study_design>
      <phase>2-3</phase>
      <hc_freetext>COVID-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group, in addition to the standard daily intervention, a capsule of a combined extract of 3 plants of Zingiber  cinnamon and zataria multiflora( 200 mg dried extract of each plant) made by Armagan Salamat Zagros Yasuj Company is consumed for one week every morning after a meal with a glass of water. On days 0,3,7,10,and 14 patients check for  temperature, presence and severity of cough,dyspnea,body pain, respiratory rate, blood oxygen saturation(by pulse oximetry)blood pressure ,pulse rate and general condition will be checked and recorded. Also basic serum samples, renal function tests , liver function tests and x-ray or CT Scan will be checked on days 0 and 7 in all patients. Intervention 2: Control group: Routine treatment according to the latest national guideline for the treatment of new corona-virus .On days 0,3,7,10,and 14 patients check for  temperature, presence and severity of cough,dyspnea,body pain, respiratory rate, blood oxygen saturation(by pulse oximetry)blood pressure ,pulse rate and general condition will be checked and recorded. Also basic serum samples, renal function tests , liver function tests and x-ray or CT Scan will be checked on days 0 and 7 in all patients.</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 There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sadrollah Mehrabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Mofateh clinic, Montazeri street,Yasuj,Iran</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591741417</zip>
        <telephone>+98 74 3322 1812</telephone>
        <email>sadrollahm@yahoo.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sadrollah Mehrabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yasuj University of Medical Sciences, Mottahari Street, Yasuj, Iran</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591741417</zip>
        <telephone>+98 74 3322 9297</telephone>
        <email>sadrollahm@yahoo.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18 years
suffering from CAovid-19 with moderate to severe symptoms
Having informed consent for entrance of study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Developing any complication during study
Covid-19 patients with poor condition(very ill or intubated)
Inability to use oral drugs
Presence of any concomitant  cardiac,hepatic or renal disease
Having any  allergy to chemical or herbal drugs
Lack of desire to continue studying</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: In this group, in addition to the standard daily intervention, a capsule of a combined extract of 3 plants of Zingiber  cinnamon and zataria multiflora( 200 mg dried extract of each plant) made by Armagan Salamat Zagros Yasuj Company is consumed for one week every morning after a meal with a glass of water. On days 0,3,7,10,and 14 patients check for  temperature, presence and severity of cough,dyspnea,body pain, respiratory rate, blood oxygen saturation(by pulse oximetry)blood pressure ,pulse rate and general condition will be checked and recorded. Also basic serum samples, renal function tests , liver function tests and x-ray or CT Scan will be checked on days 0 and 7 in all patients.</i_keyword>
      <i_keyword>Control group: Routine treatment according to the latest national guideline for the treatment of new corona-virus .On days 0,3,7,10,and 14 patients check for  temperature, presence and severity of cough,dyspnea,body pain, respiratory rate, blood oxygen saturation(by pulse oximetry)blood pressure ,pulse rate and general condition will be checked and recorded. Also basic serum samples, renal function tests , liver function tests and x-ray or CT Scan will be checked on days 0 and 7 in all patients.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Clinical symptoms ( presence and severity of dry cough). Timepoint: 0--3--7- 10-14 days after starting intervention. Method of measurement: Physical examination,questionnaire.</prim_outcome>
      <prim_outcome>Temperature. Timepoint: 0--3--7- 10-14 days after starting intervention. Method of measurement: Thermometer.</prim_outcome>
      <prim_outcome>Clinical symptoms (dyspnea). Timepoint: Daily monitoring, but the result of baseline (before the initiation of intervention), and day 3,7 10 and 14 from the initiation, is recorded. Method of measurement: Physical examination,questionnaire.</prim_outcome>
      <prim_outcome>Respiratory rate. Timepoint: Daily monitoring, but the result of baseline (before the initiation of intervention), and day 3,7 10 and 14 from the initiation, is recorded. Method of measurement: Counting the number of breaths per minute.</prim_outcome>
      <prim_outcome>Blood pressure and pulse. Timepoint: Daily monitoring, but the result of baseline (before the initiation of intervention), and day 3,7 10 and 14 from the initiation, is recorded. Method of measurement: With sphygmomanometer and pulse control.</prim_outcome>
      <prim_outcome>Oxygen saturation. Timepoint: Daily monitoring, but the result of baseline (before the initiation of intervention), and day 3,7 10 and 14 from the initiation, is recorded. Method of measurement: pulseoximeter.</prim_outcome>
      <prim_outcome>Inflammatory response. Timepoint: Days 0,7. Method of measurement: Check of IL6,IL4,CBC,CRP,ESR.</prim_outcome>
      <prim_outcome>Imaging findings. Timepoint: on the first and 7th day of treatment. Method of measurement: by chest x ray and CTscan.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Drug side effects. Timepoint: During treatment and one week later. Method of measurement: With observation, physical exam and report of patients.</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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-06</approval_date>
        <contact_name>Ethics committee of Yasuj University of Medical Sciences</contact_name>
        <contact_address>Yasuj University of Medical Sciences, Mottahari srteet, Yasuj, Iran Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
