<?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>IRCT20181203041835N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-19</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of powdered green tea in patients with coronary artery disease</public_title>
      <acronym></acronym>
      <scientific_title>The effect of powdered green tea enriched with epigallocatchin gallate (EGCG) on some clinical, electrophysiological, biochemical, inflammatory and antioxidant parameters in patients with coronary artery disease, a randomized, triple blind clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35830</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Stratified randomization by minimization method: in this method, initially, the patients will categorize based on key variables, such as age and sex. Afterwards, from the patients who will meet the inclusion criteria, the first participant will place in the intervention or control group by coin flip, and other participants will allocate to the study group with lower total of variables, Blinding description: Drug and placebo were delivered as drugs 1 and 2, and the researcher will blind to placebo or drug of capsules. The patient also will not know that he is in the drug group or placebo. The analyst will not know the groups and will perform the analysis as group 1 and 2.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Coronary Artery Disease (CAD).</hc_freetext>
      <i_freetext>Intervention 1: Control group: The group that consumes a 500 mg capsule containing cellulose .Daily two capsules for 3 months.This capsule is prepared by the Essential Oil Pharmaceutical Company. Intervention 2: Intervention group: The group that consumes a 500 mg capsule containing EGCG-rich green tea powder.Daily two capsules for 3 months.This capsule is prepared by the Essential Oil Pharmaceutical Company.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Hassanshahi Raviz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Medical School, Revolution Square, Rafsanjan</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7719617996</zip>
        <telephone>+98 34 3131 5000</telephone>
        <email>e.hassanshahi94@gmail.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ali Shamsizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Central Administration of Rafsanjan University of Medical Sciences, Imam Ali Blvd</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7719617996</zip>
        <telephone>+98 34 3428 0039</telephone>
        <email>alishamsy@gmail.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>coronary artery stenosis above 50% at least in one of the major coronary arteries and clinical stability, based on the Gensini criteria
the willingness to participate in the study
Age 40 and older</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>include allergy to green tea or components and green tea products
the use of any antioxidant supplement
daily intake of green tea before and during the study
follow a special diet
participate in another study
alcohol intake
candidate for surgery Coronary artery bypass graft (CABG)
pregnancy
lactation
perceptual disorders
unstable angina
arrhythmia
Diseases such as kidney and urinary tract and osteoporosis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic ischaemic heart disease, unspecified</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>Control group: The group that consumes a 500 mg capsule containing cellulose .Daily two capsules for 3 months.This capsule is prepared by the Essential Oil Pharmaceutical Company.</i_keyword>
      <i_keyword>Intervention group: The group that consumes a 500 mg capsule containing EGCG-rich green tea powder.Daily two capsules for 3 months.This capsule is prepared by the Essential Oil Pharmaceutical Company.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Re-admission. Timepoint: Before intervention and 3 months after study. Method of measurement: Number of patients re-admission.</prim_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: Before intervention and 3 months after study. Method of measurement: Digital barometer.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: Before intervention and 3 months after study. Method of measurement: Digital barometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of Life. Timepoint: Before intervention and 3 months after study. Method of measurement: SF36 quality of life questionnaire.</sec_outcome>
      <sec_outcome>Triglycerides. Timepoint: Before intervention and 3 months after study. Method of measurement: Autoanalysis machine.</sec_outcome>
      <sec_outcome>Low density lipoprotein. Timepoint: Before intervention and 3 months after study. Method of measurement: Autoanalysis machine.</sec_outcome>
      <sec_outcome>High density lipoprotein. Timepoint: Before intervention and 3 months after study. Method of measurement: Autoanalysis machine.</sec_outcome>
      <sec_outcome>Cholesterol. Timepoint: Before intervention and 3 months after study. Method of measurement: Autoanalysis machine.</sec_outcome>
      <sec_outcome>Blood sugar. Timepoint: Before intervention and 3 months after study. Method of measurement: Autoanalysis machine.</sec_outcome>
      <sec_outcome>Total capacity antioxidant. Timepoint: Before intervention and 3 months after study. Method of measurement: German Zellbio chromogen kit and Spectrophotometer.</sec_outcome>
      <sec_outcome>Anti-Inflammatory Cytokine Level IL-10. Timepoint: Before intervention and 3 months after study. Method of measurement: German-made Zellbio kits and Enzyme-linked immunosorbent assay (ELISA).</sec_outcome>
      <sec_outcome>Weight. Timepoint: Before intervention and 3 months after study. Method of measurement: Digital Scale.</sec_outcome>
      <sec_outcome>Body mass index. Timepoint: Before intervention and 3 months after study. Method of measurement: Using the formula: Weight (kg) per square meter height.</sec_outcome>
      <sec_outcome>Waist circumference. Timepoint: Before intervention and 3 months after study. Method of measurement: Strip meter.</sec_outcome>
      <sec_outcome>Wrist circumference. Timepoint: Before intervention and 3 months after study. Method of measurement: Strip meter.</sec_outcome>
      <sec_outcome>Abdominal circumference. Timepoint: Before intervention and 3 months after study. Method of measurement: Strip meter.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: Before intervention and 3 months after study. Method of measurement: Digital monitor device.</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>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-14</approval_date>
        <contact_name>Ethics committe of Rafsanjan University of Medical Sciences</contact_name>
        <contact_address>Central Administration of Rafsanjan University of Medical Sciences, Imam Ali Blvd Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
