<?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>IRCT20100130003227N15</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-10</date_registration>
      <primary_sponsor>Khomein Medical University</primary_sponsor>
      <public_title>The effect of Hyssop and Verbascum herbal tea on clinical symptoms of Covide-19.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Hyssop and Verbascum herbal tea on clinical symptoms of Covide-19.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52719</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method and description: The randomization method is based on gradual references and having the inclusion criteria and interest in participating in the study. 
Randomization unit: Man
Random layers:
Material of randomization tool: Random number table
How to build a random sequence: Sequence 
Allocation concealment: The subjects are randomly assigned to two groups (intervention and control) using a table of random numbers. The randomization sequence will be generated based on 4 random permutation blocks using a web-based software (from website: https://www.sealedenvelope.com). The randomization sequence will be provided to the project manager and will be hidden from the person participating in the study and the evaluator's colleague to enter the study until the intervention, Blinding description: Blinding in this study was double-blind. So that the participants and the outcome assessor were unaware of what group the research units were in. 
Participants were randomly assigned to the intervention and control groups and will not be aware of the type of intervention (Hyssop and Verbascum herbal tea in addition to common drugs for the treatment of Covide 19 or only conventional treatment) before the study start. Assessors, health care personnel (physicians, nurses, etc.) who are responsible for patient care will also not be aware of patient grouping.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Covid-19.</hc_freetext>
      <i_freetext>Intervention 1: "Intervention group": Using the Hyssop (30 grams in 24 hours) and Verbscum (15 grams in 24 hours) herbal tea three times a day (For 7 to 10 days) for patients with Covid 19 disease along with commonly used treatments such as: Favipiravir, Recigen, Tocilizumabe, Dexamethasone, Methylprednisolone, Doxycycline, Meropenem, Ceftriaxone, Levofloxacin, Salbutamol spray, Atrovent spray, Seroflu spray and etc. Intervention 2: Control group: Use of common drugs for the treatment of Covid 19 disease such as: Favipiravir, Recigen, Tocilizumabe, Dexamethasone, Methylprednisolone, Doxycycline, Meropenem, Ceftriaxone, Levofloxacin, Salbutamol spray, Atrovent spray, Seroflu spray and etc.</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Taheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qods Boulevard</address>
        <city>Khomein</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>38817-43364</zip>
        <telephone>+98 86 4622 1533</telephone>
        <email>rheum.nursing@gmail.com</email>
        <affiliation>Khomein School of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ashraf Salehi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qods  Boulevard</address>
        <city>Khomein</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>38817-43364</zip>
        <telephone>+98 86 4622 1533</telephone>
        <email>najm54@yahoo.com</email>
        <affiliation>Khomein School of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who are clinically proven by PCR and different views on CT scan ( With the confirmation of an infectious disease specialist).
Clinically be in moderate and severe groups.
Without organ damage.
Age over 18 years.
Be in a stable cardiovascular condition.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient death during study
Reluctance to continue cooperation
Occurrence of any allergies following the use of plants
Patient treated with chemotherapy or radiotherapy
History of cancer
History of chronic autoimmune diseases
People with seizures and epilepsy
Nervous patients
Pregnancy
Breastfeeding
End Stage
People with chronic kidney failure
Liver failure
Encephalopathy
Neuropathy</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 - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"Intervention group": Using the Hyssop (30 grams in 24 hours) and Verbscum (15 grams in 24 hours) herbal tea three times a day (For 7 to 10 days) for patients with Covid 19 disease along with commonly used treatments such as: Favipiravir, Recigen, Tocilizumabe, Dexamethasone, Methylprednisolone, Doxycycline, Meropenem, Ceftriaxone, Levofloxacin, Salbutamol spray, Atrovent spray, Seroflu spray and etc.</i_keyword>
      <i_keyword>Control group: Use of common drugs for the treatment of Covid 19 disease such as: Favipiravir, Recigen, Tocilizumabe, Dexamethasone, Methylprednisolone, Doxycycline, Meropenem, Ceftriaxone, Levofloxacin, Salbutamol spray, Atrovent spray, Seroflu spray and etc.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Improvement the symptoms of Covide-19disease. Timepoint: Seventh and tenth day. Method of measurement: Intensity of cough- Intensity of shortness of breath- O2 Saturation- Duration of hospitalization in the ward- Respiration Rate- Three-dimensional CT scan changes of the lungs- CBC.diff and ESR and CRP.</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>Khomein Medical University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-28</approval_date>
        <contact_name>Ethics Committees, Khomain University of Medical Sciences</contact_name>
        <contact_address>Quds Boulevard Khomein Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
