<?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>IRCT20201015049036N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-27</date_registration>
      <primary_sponsor>Dezfoul University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of Date Palm Leaf Extract (Phoenix dactylifera) in Patients with COVID-19 Hospitalized in Ganjavian Hospital in Dezful</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of Palm Leaf Extract (Phoenix dactylifera) in Patients with COVID-19 Patients Admitted to Ganjavian Hospital in Dezful with Mild to Moderate Stages: A Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51772</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The study will be conducted in cooperation with infectious and internal specialists and pulmonary specialists, Randomization description: Patients with inclusion criteria and with respect to their genders will be assessed clinically. The patients will be divided into to two groups randomly: drug recipients and placebo recipients. The patients will be assigned certain codes, and only the pharmacy team will be aware of the nature of the two groups. The physician in chief, the nurses  and the patients are not aware of whether they are receiving drug or placebo.placebo of the syrup, Blinding description: Patients use drugs and placebo that are in exactly the same containers and labels but have different codes, and except for the pharmacy team, none of the treating physicians, nurses, and patients are aware of those codes.</study_design>
      <phase>2</phase>
      <hc_freetext>Coronavirous (COVID19).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: treatment- medicine: Phoenix medicine (contains hydro alcoholic solution, Phoenix leaf extract, Vitamin C and Strawberry flavoring) 5 times/day, each time 5 ml. Intervention 2: Control group: treatment-placebo: contains hydro alcoholic solution, Vitamin C , Strawberry flavoring, without Phoenix leaf extract)                    5 times/day, each time 5 ml.</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 data will be collected by an epidemiologist's cooperation after the jamming.

When:
Two months.

To whom:
Dr Gholamreza Amin , Ghasem Takdehghan؛ Dr. Mohammad Dorchin

Conditions:
Only for data collection and analysis.

Where to obtain:
Dr. Mohammad Dorchin

How to obtain:
Written request and approval of the project's executive and the main colleagues of the project (Dr. Gholamreza Amin and Mr. Ghasem Takdehghan)

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Dorchin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.440 west Farhang 2 Ave.</address>
        <city>Dezful</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6461896973</zip>
        <telephone>+98 61 4255 6011</telephone>
        <email>dr.dorchin@gmail.com</email>
        <affiliation>Dezfoul University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Dorchin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.440 west Farhang2 Ave.</address>
        <city>Dezful</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6461896973</zip>
        <telephone>+98 61 4255 6011</telephone>
        <email>dr.dorchin@gmail.com</email>
        <affiliation>Dezfoul University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients &gt;12 years of age (male/female) with mild to moderate disease, which can be determined by clinical criteria (dry cough, fever and dyspnea) and paraclinical indices PO2, PCR, CT Scan, CRP, CBC
Signing the form of consent by persons &gt;18 years of age or the guardians of the under-aged patients</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Dissatisfaction of patients or the patients' guardians
Any allergic reactions from the use of the palm extract
Critically ill patients or the cases where the physician in chief may not recommend this intervention for hospitalized patients</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Corona virus infection, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: treatment- medicine: Phoenix medicine (contains hydro alcoholic solution, Phoenix leaf extract, Vitamin C and Strawberry flavoring) 5 times/day, each time 5 ml.</i_keyword>
      <i_keyword>Control group: treatment-placebo: contains hydro alcoholic solution, Vitamin C , Strawberry flavoring, without Phoenix leaf extract)                    5 times/day, each time 5 ml.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lung infection. Timepoint: At the beginning of entering the plan, at the end of the first week of treatment and at the end of the second week of treatment. Method of measurement: CT Scan.</prim_outcome>
      <prim_outcome>Virus diagnosis. Timepoint: At the beginning of entering the plan, at the end of the first week of treatment and at the end of the second week of treatment. Method of measurement: PCR.</prim_outcome>
      <prim_outcome>Fever. Timepoint: At the beginning of entering the plan, at the end of the first week of treatment and at the end of the second week of treatment. Method of measurement: Thermometer.</prim_outcome>
      <prim_outcome>PaO2: oxygen pressure in arterial blood. Timepoint: At the beginning of entering the plan, at the end of the first week of treatment and at the end of the second week of treatment. Method of measurement: Record the degree of oxygen pressure.</prim_outcome>
      <prim_outcome>CRP: reactive protein in blood for detect the inflammation. Timepoint: At the beginning of entering the plan, at the end of the first week of treatment and at the end of the second week of treatment. Method of measurement: Comparison with normal standard range in blood test.</prim_outcome>
      <prim_outcome>ESR: erythrocyte sedimentation rate used to monitor inflammatory diseases. Timepoint: At the beginning of entering the plan, at the end of the first week of treatment and at the end of the second week of treatment. Method of measurement: Comparison with normal standard range in blood test.</prim_outcome>
      <prim_outcome>WBC: white blood cell. Timepoint: At the beginning of entering the plan, at the end of the first week of treatment and at the end of the second week of treatment. Method of measurement: Comparison with normal standard range in blood test.</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>University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-06</approval_date>
        <contact_name>Ethics Committee Dezful University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for rsearch, Dezful University of Medical Sciences, Azadegan alley, Andimeshk road to Dezful Dezful Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
