<?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>IRCT20200609047707N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-24</date_registration>
      <primary_sponsor>Esfarayen University of Medical Sciences</primary_sponsor>
      <public_title>Effective of Elman tablet on COVID-19 infection severity</public_title>
      <acronym></acronym>
      <scientific_title>Effective of Elman tablet on illness severity and length of hospital stay in the patients with COVID-19 infection</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-07-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48764</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is simple. Random units are each of patients infected with covid-19 that admitted to the emergency department. Also, The randomization tool is  a random number table. The researcher select one of the numbers in the random numbers table and moves to the right and down. Record the numbers and assign them to different study groups whose numbers are already specified.</study_design>
      <phase>3</phase>
      <hc_freetext>Patients infected with Covid-19.</hc_freetext>
      <i_freetext>Intervention 1: First Intervention group (Elman Tablet): The tablet has an effective drug combination of L-cysteine, C3H7NO2S chemical formula and chemical structure of HS-CH2-CH (NH2) -COOH with L stereochemistry and a molar mass of 121.16 grams per mole and soluble in water. Each Elman tablet contains 60 mg of L-cysteine (Pharmaceutical active ingredient). Each patient takes this pill three times every 8 hours. It is recommended to take this medicine at least two hours apart from the prescription of the routine medications for six days. Manufacturing Company is Simorgh Attar Neishabour Pharmaceutical . It is prescribed along with routine drugs for treatment of covid-19. Intervention 2: Second Intervention group (Placebo): It contains a combination of malodextrin, an oligo or polysaccharide with the formula C6nH10n + 2 O5n + 1, and is obtained from starch hydrolysis in a simple process. The powder is white and soluble in water. The placebo is given with a very similar appearance to the original medicine and is given orally every 8 hours for six days. Drugs associated with the treatment of Qovid-19 disease are prescribed according to the routine. Intervention 3: Control group: Drugs associated with the treatment of Covid-19 disease are prescribed according to the routine( hydroxychloroquine 200 mg and Kaletra).</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:
Document will be registered "Pajouhan" system after completion of the study . Also, participants general information and the effectiveness of interventions will be recorded in the article.

When:
Accessibility after publish of article

To whom:
People interested in medicine scope

Conditions:
People looking for ways to covid-19 recovery who can access the data.

Where to obtain:
Esfarāyen faculty of medical sciences, imama Reza Street, Esfarāyen, North Khorasan

How to obtain:
They can access to data through below email as soon as possible s.j.hoseini2016@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Javad Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Esfarayen faculty of medical sciences, Imam Reza street, Esfarayen, North Khorasan</address>
        <city>Esfarayen</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9661777944</zip>
        <telephone>0098 5831550000- 602</telephone>
        <email>S.j.hoseini2016@gmail.com</email>
        <affiliation>Esfarayen University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Essa Tohidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Esfarayen faculty of medical sciences, imam Reza Street, Esfarayen town, North Khorasan, Iran</address>
        <city>Esfarayen</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>96617-77944</zip>
        <telephone>+98 58 3722 9050</telephone>
        <email>Issatohidi201648@gmail.com</email>
        <affiliation>Esfarayen University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients diagnosed with COVID-19 disease based on PCR test
The level of consciousness should be 15</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy and lactation
Connect the patient to the ventilator
Low blood pressure at the beginning of the study (below 80/12)
Has a history of gastrointestinal bleeding or active bleeding in the body
Patients with immunodeficiency (under chemotherapy, organ transplantation and bone marrow transplantation, and patients with autoimmune diseases)</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>Placebo</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First Intervention group (Elman Tablet): The tablet has an effective drug combination of L-cysteine, C3H7NO2S chemical formula and chemical structure of HS-CH2-CH (NH2) -COOH with L stereochemistry and a molar mass of 121.16 grams per mole and soluble in water. Each Elman tablet contains 60 mg of L-cysteine (Pharmaceutical active ingredient). Each patient takes this pill three times every 8 hours. It is recommended to take this medicine at least two hours apart from the prescription of the routine medications for six days. Manufacturing Company is Simorgh Attar Neishabour Pharmaceutical . It is prescribed along with routine drugs for treatment of covid-19.</i_keyword>
      <i_keyword>Second Intervention group (Placebo): It contains a combination of malodextrin, an oligo or polysaccharide with the formula C6nH10n + 2 O5n + 1, and is obtained from starch hydrolysis in a simple process. The powder is white and soluble in water. The placebo is given with a very similar appearance to the original medicine and is given orally every 8 hours for six days. Drugs associated with the treatment of Qovid-19 disease are prescribed according to the routine.</i_keyword>
      <i_keyword>Control group: Drugs associated with the treatment of Covid-19 disease are prescribed according to the routine( hydroxychloroquine 200 mg and Kaletra).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Illness severity. Timepoint: Every 12 hours for six day. Method of measurement: Using the checklist.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Length of hospital stay. Timepoint: It is controlled daily. Method of measurement: Calculate the number of days hospitalized within the corona ward.</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>Esfarayen University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-07</approval_date>
        <contact_name>Ethics committee of Esfarayen faculty of medical sciences</contact_name>
        <contact_address>Esfarayen faculty of medical sciences, Imam Reza street, Esfarayen, North Khorasan Esfarayen North Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
