<?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>IRCT20171129037678N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-09</date_registration>
      <primary_sponsor>The University of Mohaghegh Ardabili</primary_sponsor>
      <public_title>The effect of saffron and endurance exercise in patients with coronavirus</public_title>
      <acronym></acronym>
      <scientific_title>The effect of saffron supplementation and endurance training on the improvement of clinical and laboratory manifestations in outpatients with coronavirus</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67836</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Supportive, Randomization description: The patient receives the drug (intervention or comparison group) in sealed envelopes that have a code. Coding is done by one of the project colleagues and the doctor, evaluator and patient do not know anything, Blinding description: The patient receives the drug (intervention or comparison group) in sealed envelopes that are coded. Coding is done by one of the colleagues of the project and the doctor, evaluator and patient do not know anything.</study_design>
      <phase>N/A</phase>
      <hc_freetext>coronavirus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: patients in this group, in addition to drug treatment according to the national guidelines for the new coronavirus, They receive saffron supplements for 14 days. (400 mg equivalent to 5.7 mg per kilogram of body weight per day). Intervention 2: Control group: Patients in this group receive drug treatment according to the national guidelines for the new coronavirus. Intervention 3: Intervention group: Patients in this group, in addition to the medical treatment according to the national guidelines for the new coronavirus, two weeks of endurance exercise (12 sessions2 hours, four sessions per week, aerobic exercise with an intensity of 65% of the maximum heart rate). Intervention 4: Intervention group: Patients in this group receive saffron supplement for 14 days, in addition to the medical treatment according to the national guidelines for the new coronavirus. (400 mg equal to 5.7 mg per kilogram of body weight per day) plus two weeks of endurance training (12 sessions 2 hours, four sessions per week, aerobic exercise with an intensity of 65% of maximum heart rate).</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 data is potentially shareable after de-identifying individuals

When:
After completing the plan

To whom:
Only for researchers working in academic and scientific institutions

Conditions:
For research

Where to obtain:
Email address of the researcher

How to obtain:
Email address of the researcher

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme Halalkhor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Physical Education and Sport Sciences, University of Tabriz, 29 Bahman BLVD, Tabriz, East Azarbaijan</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5447135411</zip>
        <telephone>+98 41 4224 1099</telephone>
        <email>fateme.halalkhor@gmail.com</email>
        <affiliation>University of Tabriz</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Halalkhor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Physical Education and Sport Sciences, University of Tabriz, 29 Bahman BLVD, Tabriz, East Azarbaijan</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5447135411</zip>
        <telephone>+98 41 4224 1099</telephone>
        <email>fateme.halalkhor@gmail.com</email>
        <affiliation>University of Tabriz</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Outpatients with covid 19</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of allergy to saffron and its derivatives
People with liver, kidney and respiratory disorders
Lactating and pregnant women</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B34.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Coronavirus infection, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: patients in this group, in addition to drug treatment according to the national guidelines for the new coronavirus, They receive saffron supplements for 14 days. (400 mg equivalent to 5.7 mg per kilogram of body weight per day)</i_keyword>
      <i_keyword>Control group: Patients in this group receive drug treatment according to the national guidelines for the new coronavirus.</i_keyword>
      <i_keyword>Intervention group: Patients in this group, in addition to the medical treatment according to the national guidelines for the new coronavirus, two weeks of endurance exercise (12 sessions2 hours, four sessions per week, aerobic exercise with an intensity of 65% of the maximum heart rate).</i_keyword>
      <i_keyword>Intervention group: Patients in this group receive saffron supplement for 14 days, in addition to the medical treatment according to the national guidelines for the new coronavirus. (400 mg equal to 5.7 mg per kilogram of body weight per day) plus two weeks of endurance training (12 sessions 2 hours, four sessions per week, aerobic exercise with an intensity of 65% of maximum heart rate).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cough. Timepoint: Before and 14 days after the start of treatment. Method of measurement: Physical examination.</prim_outcome>
      <prim_outcome>Breathing rate. Timepoint: Before and 14 days after the start of treatment. Method of measurement: Physical examination.</prim_outcome>
      <prim_outcome>Body temperature. Timepoint: Before and 14 days after the start of treatment. Method of measurement: Physical examination.</prim_outcome>
      <prim_outcome>Speed of improvement. Timepoint: Before and 14 days after the start of treatment. Method of measurement: Physical examination.</prim_outcome>
      <prim_outcome>Inflammatory biomarkers. Timepoint: Before and 14 days after the start of treatment. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>The amount of C-reactive protein. Timepoint: Before and 14 days after the start of treatment. Method of measurement: blood test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Serum level of specific IgG antibody for N and S antigens. Timepoint: One month after training. Method of measurement: Eliza method.</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>The University of Mohaghegh Ardabili</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-20</approval_date>
        <contact_name>Ethics Committee of Sport Sciences Research Institute</contact_name>
        <contact_address>No. 3, Fifth Alley, MirEmad St., Motahari St., Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
