<?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>IRCT20210907052400N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-06</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>The effects of coenzyme Q10 on cerebral infarction</public_title>
      <acronym>CoQ10</acronym>
      <scientific_title>Effects of oral administration of ubiquinone in cerebral stroke patients on the neurologic, psycho-cognitive and oxidative stress disorders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58721</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: n this study, a neurologist selects ischemic stroke patients according to inclusion and non-inclusion criteria and introduces them to researchers.  After fully explaining the treatment process of this study to patients and obtaining written consent, the researchers enter the patients into the study. After conducting initial assessments, the evaluating researcher provides the physician and nurses with therapeutic intervention, including capsules containing CO Q10 powder and placebo capsules (containing glucose powder), to be placed in the patient's order. The capsules are exactly the same in appearance and packaging, and the medical staff will not be aware of their main contents. The leader researcher in this study is blind and only researchers evaluating and analyzing the data will be aware of the patient classification.</study_design>
      <phase>3</phase>
      <hc_freetext>Ischemic stroke.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Half of the patients placed in the intervention group by the researcher; After initial evaluation of the initial variables and discharge from the hospital, they begin interventional therapy, which is complementary drug therapy with coenzyme Q10. In this study, patients will consume 600 mg of oral CoQ10 daily in the form of 200 mg capsules (3 servings per day) one hour before the main meals of breakfast, lunch and dinner for 30 days. The coenzyme Q10 oral powder used in this study; It is 98% pure and is made in South Korea. Intervention 2: Control group: The other half of the patients included in the study will be in the control group by the researcher of this study. All evaluations of patients in the intervention group will be performed at the beginning of the study and after discharge from the hospital, as in the first group, they will receive placebo capsules as complementary therapy; Take 3 servings of placebo capsules for 30 days. Patients who are blinded by the type of segmentation and the type of intervention; They receive a 200 mg capsule similar to the intervention capsules. The contents of the capsules of this group are filled with glucose powder.</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:
In this study, only the results related to the study variables will be published

When:
Access starts 6 months after the results are published

To whom:
All people who are related to scientific and academic centers and industries related to health care can apply.

Conditions:
Only as a scientific source with the names of the authors are allowed to use the results.

Where to obtain:
Using e-mail addresses, they can contact the researchers of this study and the Vice Chancellor for Research and Technology of the University.  
 Dr. Siamak Shahidi, shahidi@umsha.ac.ir 
Dr. Mojtaba, Khazaei, khazaeimojtaba@yahoo.com 
Ali Mojaver, a.mojaver.edu@umsha.ac.ir

How to obtain:
Applicants can send an email to the author responsible for the published articles. Request a copy of the article file. To be sent to them by e-mail.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mojtaba Khazaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Be'sat hospital, Shahid Beheshti Blvd, Hamadan</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6516798798</zip>
        <telephone>+98 81 3565 0030</telephone>
        <email>khazaeimojtaba@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Siamak Shahidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of physiology, School of medicine, Hamadan University of medical sciences, Shahid Fahmide St, Hamedan</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838678</zip>
        <telephone>+98 81 3822 2104</telephone>
        <email>shahidi@umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with acute ischemic stroke
Patients who have had a stroke for the first time
Patients between the ages of 20 and 80</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having other neurodegenerative disorders
Having acute mental disorders
Having liver and kidney malignancies
Having rheumatism and chronic infections
Taking vitamin supplements and immune boosters in the last month</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I63</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cerebral infarction</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: Half of the patients placed in the intervention group by the researcher; After initial evaluation of the initial variables and discharge from the hospital, they begin interventional therapy, which is complementary drug therapy with coenzyme Q10. In this study, patients will consume 600 mg of oral CoQ10 daily in the form of 200 mg capsules (3 servings per day) one hour before the main meals of breakfast, lunch and dinner for 30 days. The coenzyme Q10 oral powder used in this study; It is 98% pure and is made in South Korea.</i_keyword>
      <i_keyword>Control group: The other half of the patients included in the study will be in the control group by the researcher of this study. All evaluations of patients in the intervention group will be performed at the beginning of the study and after discharge from the hospital, as in the first group, they will receive placebo capsules as complementary therapy; Take 3 servings of placebo capsules for 30 days. Patients who are blinded by the type of segmentation and the type of intervention; They receive a 200 mg capsule similar to the intervention capsules. The contents of the capsules of this group are filled with glucose powder.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Oxidative stress. Timepoint: Immediately after the stroke event and before starting coenzyme Q10 treatment and then 30 days after consuming oral coenzyme Q10. Method of measurement: Spectroscopy (by taking a blood sample).</prim_outcome>
      <prim_outcome>Sensory-motor function. Timepoint: Immediately after the stroke event and before starting coenzyme Q10 treatment and then 30 days after consuming oral coenzyme Q10. Method of measurement: Using Berg Balance Scale.</prim_outcome>
      <prim_outcome>Psycho-cognitive function. Timepoint: Immediately after the stroke event and before starting coenzyme Q10 treatment and then 30 days after consuming oral coenzyme Q10. Method of measurement: Using the MoCA questionnaire.</prim_outcome>
      <prim_outcome>Physical activity rate. Timepoint: Immediately after the stroke event and before starting coenzyme Q10 treatment and then 30 days after consuming oral coenzyme Q10. Method of measurement: Using SIMPAQ questionnaire and Barthel index.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-04</approval_date>
        <contact_name>Ethics committee of Hamadan University of Medical Sciences</contact_name>
        <contact_address>Hamadan university of medical sciences, Shahid Fahmideh Blvd, Hamadan Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
