<?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>IRCT20200509047373N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-23</date_registration>
      <primary_sponsor>Health Medicine Chemistry Company</primary_sponsor>
      <public_title>Evaluation effect of Dinvl for Covid19 infection</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation effects of DINVL herbal medicine on the recovery of patients with COVID - 19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48001</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, patients with admission conditions were divided into two groups. In addition to the usual treatment for coronavirus infection, the intervention group received Dinvl daily for 7consecutive days, but the control group received only routine treatment for corona infection , Randomization description: In this study, the random number table method is used for randomization.The randomization unit is also the individual.To read numbers, it is also from left to right.For concealment, the method of sequentially numbered, sealed, opaque envelopes is used, Blinding description: In this study, patients, the main researcher, the physician who visits patients daily for response to the treatment and examination of symptoms, and is responsible for collecting information, and the nursing staff are kept blind to the allocation of study groups.All patients are visited daily by one of the physicians of the treatment team who is in the process of intervention.However, the follow-up of the side effects of the drug and the evaluation of the course of treatment in patients will be performed by another physician, who is also in the general study constant.This physician will monitor the condition of patients at home for up to 4 weeks after discharge and will be completely blind.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Pneumonia induced by covid19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:ُُDinvl drug,260 mg each time, 4 times a day for 7 days. Made by Health Medicine Chemistry Company. Intervention 2: Control group:  Routine  tablets is given daily for seven days.</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:
All participants' data is shared after it becomes unrecognizable

When:
Data access starts immediately after printing the results

To whom:
The data in this study are only available to medical researchers

Conditions:
It is available for any analysis or use that aims to improve and progress in the treatment of covid19 infection

Where to obtain:
Contact email address:ahisseinpour3@gmail.com

How to obtain:
In case of requesting data for the study, the applicant must first introduce himself or herself and the relevant organization to determine the purpose of the data request and state for what purpose this data is used.After submitting the request, if the researchers of this study prove that the data of this study can advance the therapeutic goals, the information will be sent as long as the data remains confidential.This process takes two weeks.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ahmad Hosseinpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 256, Alley 7, Peace Boulevard, Skills Square, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7177654547</zip>
        <telephone>+98 71 3739 7910</telephone>
        <email>ahosseinpour3@gmail.com</email>
        <affiliation>Health Medicine Chemistry Company</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ahmad Hosseinpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 256, Alley 7, Peace Boulevard, Skills Square, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7177654547</zip>
        <telephone>+98 71 3739 7910</telephone>
        <email>ahosseinpour3@gmail.com</email>
        <affiliation>Health Medicine Chemistry Company</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients  up18  years old hospitalized
Patient with SpO2:85-89% on room air at admission (if correct with nasal O2 maximum 6 liter/min to SpO2&gt;=90 )
Patients with SpO2: 90-93% and RR&gt;=30 clinical compatible
patients with positive RT-PCR test or consistent HRCT to covid19
pneumonia Sign the study participation form</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Known sensitivity to plant compounds.
Pregnant woman Lactating woman Patients with active peptic.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19, virus identified</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:ُُDinvl drug,260 mg each time, 4 times a day for 7 days. Made by Health Medicine Chemistry Company</i_keyword>
      <i_keyword>Control group:  Routine  tablets is given daily for seven days</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Time to clinical recovery. Timepoint: Control clinical signs daily until discharge from the hospital. Method of measurement: Fever control with thermometer, oxygen saturation control with pulsoximetry.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>14 days readmission after discharge. Timepoint: Up to 14 days after discharge. Method of measurement: All patients will be given a contact number to notify them if they are hospitalized again. All patients will be monitored by phone weekly for up to 4 weeks after the first day they are admitted.</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>Health Medicine Chemistry Company</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-09</approval_date>
        <contact_name>Medical Ethics Committee of Baqiyatallah University of Medical Sciences</contact_name>
        <contact_address>Baqiyatallah University of Medical Sciences, Molla Sadra Street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
