<?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>IRCT20161108030776N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-26</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Effect of donkey milk on the new corona virus infection</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of dairy product donkey milk on the course of signs of patients with suspected corona disease (COVID-19)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50341</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, according to the inclusion criteria, patients are selected and then according to the random sequence obtained through random allocation software, in the same random order, patients will be divided into two groups of test and control.</study_design>
      <phase>N/A</phase>
      <hc_freetext>COVID-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In addition to drug treatment according to the protocol of the Ministry of Health, patients in this group receive donkey milk at a rate of 300 cc daily with 5 grams of candy for 5 days. Intervention 2: Control group: Patients in this group receive medication according to the protocol of the Ministry of Health.</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:
Information on the main outcome will be published after the end of the study.

When:
Immediately after publishing the article

To whom:
All researchers

Conditions:
The data and results can be used by all researchers for research in the fields related to this study.

Where to obtain:
Haleh Tajadini;  dr_haleh@yahoo.com
Mohadese Kamali; mohadesekamali0912@gmail.com

How to obtain:
The data will be provided to the applicant within one month after reviewing and confirming the application.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Haleh Tajadini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Persian Medicine, Amirkabir Intersection, Jomhuri Eslami Boulevard</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618843883</zip>
        <telephone>+98 34 3211 0860</telephone>
        <email>dr_haleh@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Haleh tajadini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Persian Medicine, Amirkabir Intersection, Jomhuri Eslami Boulevard</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618843883</zip>
        <telephone>+98 34 3211 0860</telephone>
        <email>dr_haleh@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with COVID-19
Mild to moderate disease
Candidates for outpatient treatment based on the protocol of the Ministry of Health
Patients 18-65 years old</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with allergies and asthma
Patients with hypertension
Patients with diabetes
Pregnancy / lactation
Patients with heart failure
Patients with chronic renal failure
Patients undergoing chemotherapy
Patients receiving corticosteroids
Patients with immunodeficiency</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 addition to drug treatment according to the protocol of the Ministry of Health, patients in this group receive donkey milk at a rate of 300 cc daily with 5 grams of candy for 5 days.</i_keyword>
      <i_keyword>Control group: Patients in this group receive medication according to the protocol of the Ministry of Health.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Body temperature. Timepoint: Days 0-1-2-3-4-7-14 after the start of the intervention. Method of measurement: Mercury thermometer.</prim_outcome>
      <prim_outcome>Cough (severity-frequency). Timepoint: Days 0-1-2-3-4-7-14 after the start of the intervention. Method of measurement: Fiston Scale.</prim_outcome>
      <prim_outcome>Weakness and lethargy. Timepoint: Days 0-1-2-3-4-7-14 after the start of the intervention. Method of measurement: Visual analog scale (VAS).</prim_outcome>
      <prim_outcome>Body pain. Timepoint: Days 0-1-2-3-4-7-14 after the start of the intervention. Method of measurement: Visual analog scale (VAS).</prim_outcome>
      <prim_outcome>Breathing speed. Timepoint: Days 0-1-2-3-4-7-14 after the start of the intervention. Method of measurement: Count the number of breaths per minute.</prim_outcome>
      <prim_outcome>Diarrhea (watery stools). Timepoint: Days 0-1-2-3-4-7-14 after the start of the intervention. Method of measurement: Question from the patient.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Being admitted to the hospital. Timepoint: Days 0-1-2-3-4-7-14 after the start of the intervention. Method of measurement: The ratio of the number of cases leading to hospitalization to the total number of patients in each group.</sec_outcome>
      <sec_outcome>Death rate. Timepoint: Days 0-1-2-3-4-7-14 after the start of the intervention. Method of measurement: Ratio of number of deaths to total patients in each group.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-08-15</approval_date>
        <contact_name>Kerman University of Medical Sciences</contact_name>
        <contact_address>campus of University of Medical Sciences, the beginning of Haft Bagh Alavi axis Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
