<?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>IRCT20131125015536N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-06-19</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Nano-curcumin in Coronary Slow Flow Phenomenon</public_title>
      <acronym></acronym>
      <scientific_title>The study of the effect of nano-curcumin supplementation on biomarkers of endothelial function and inflammation in overweight or obese patients with Coronary Slow Flow Phenomenon</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40083</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Study participants will be assigned to nano-curcumin or placebo groups by stratified permuted block randomization. As the first step, we will have stratified randomization for gender. Then, either points 1 or 0 will be given to various confounding factors in this study. For example, having family history of coronary artery disease: 1 and no family history of CAD: 0, 
diabetes mellitus:1 , no diabetes mellitus: 0
hypertention: 1, no hypertention: 0
dyslipidemia: 1 , no dyslipidemia: 0
smoker:1 , non-smoker:0
Using any of these medications: ACE-I, ARBs, beta-blockers, statins, anticoagulants, calcium channel blockers and nitrates: 0, no use: 1.
The sum of these points will be a score between 0 to 6 for each patient. The patients with scores 3 and below will be considered as low risk and patients with scores equivalent to or higher than 4 will be considered as high risk for condition of the disease and then, they will go through stratified randomization according to their risk level.
Patients are randomized by using permuted blocks of size 4 and 6 (specific random number tables will be used), Blinding description: Using identical boxes with either A or B code labels for nano-curcumin and placebo supplements, will help to blind both patients and investigators.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Coronary Slow Flow Phenomenon (CSFP).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Dietary supplement nano-curcumin 80 mg one capsule daily (Exir Nano Sina Co.). Intervention 2: Control group: Placebo supplement one capsule daily (Exir Nano Sina Co.).</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is "There is no further information"</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahsa Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No: 44, Hojjat-dost Alley, Naderi St., Keshavarz Blvd, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1416643931</zip>
        <telephone>+98 21 8895 5975</telephone>
        <email>mahsarezaei1372@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad-Javad Hosseinzadeh-Attar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.44, Hojjatdoust Alley, Naderi Ave, Keshavarz Blvd, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1416643931</zip>
        <telephone>+98 21 8895 5569</telephone>
        <email>mhosseinzadeh@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>35 to 70 years old men and women
BMI range: 25 - 39.9
Angiographically diagnosed as coronary slow flow phenomenon by Corrected TIMI Frame Count (CTFC) method which is equivalent to 27 or higher for one or more coronary vessels.
Normal coronary vessels with coronary stenosis less than 40%
Left ventricular ejection fraction higher than 45%
Giving informed consent for participation in the study</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Premature menopause
addiction or alcohol consumption
Routine use of NSAIDs or antioxidants one month prior to study
Use of aphrodisiac medication within 9 months before study
Routine use of corticosteroids or immunosuppressants
Use of anticonvulsants
Taking antioxidant or omega3 supplements (more than 3 grams per day) at least twice a week within 3 months prior to study
Taking vitamin B12, folic acid or vitamin B6 supplements within one month before study
Being a professional athlete or execising regularly
Uncontrolled hypertension defined as diastolic blood pressure above 90 mmHg, systolic blood pressure above 140 mmHg.
Past medical history: hypothyroidism or hyperthyroidism
Malignancy
Chronic obstructive pulmonary diseases
Systemic diseases
Connective tissue diseases
Renal failure
Liver failure
Autoimmune diseases
Myocardial Infarction
Sever heart failure
Heart transplant
Revascularization procedure or PCI or CABG
Left ventricular dysfunction or echocardiographically diagnosed left ventricular hypertrophy
Cardiac conduction disturbances
Valvular heart disease
Atrial fibrillation
Aneurysms
Cardiomyopathy
Congenital heart disease
Coronary artery disease
Hematologic disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I20.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other forms of angina pectoris</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Dietary supplement nano-curcumin 80 mg one capsule daily (Exir Nano Sina Co.)</i_keyword>
      <i_keyword>Control group: Placebo supplement one capsule daily (Exir Nano Sina Co.)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum Homocysteine levels. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Enzymatic Kit.</prim_outcome>
      <prim_outcome>Serum Adropin levels. Timepoint: Before and after 12 weeks of intervention. Method of measurement: ELISA kit.</prim_outcome>
      <prim_outcome>Serum Endocan levels. Timepoint: Before and after 12 weeks of intervention. Method of measurement: ELISA kit.</prim_outcome>
      <prim_outcome>Different aspects of angina pectoris. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Seattle Angina Questionnore.</prim_outcome>
      <prim_outcome>Serum visfatin level. Timepoint: Before and after 12 weeks of intervention. Method of measurement: ELISA kit.</prim_outcome>
      <prim_outcome>Serum hs-CRP level. Timepoint: Before and after 12 weeks of intervention. Method of measurement: ELISA kit.</prim_outcome>
      <prim_outcome>Serum uric acid level. Timepoint: Before and after 12 weeks of intervention. Method of measurement: enzymatic kit.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before and after 12 weeks of intervention. Method of measurement: SF-36 items questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Body composition analysis. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Bio-electrical impedance analysis.</sec_outcome>
      <sec_outcome>Serum lipid profile. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Enzymatic Kit.</sec_outcome>
      <sec_outcome>Serum alkaline phosphatase levels. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Enzymatic Kit.</sec_outcome>
      <sec_outcome>Serum insulin level. Timepoint: Before and after 12 weeks of intervention. Method of measurement: ELISA kit.</sec_outcome>
      <sec_outcome>Serum urea level. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Enzymatic Kit.</sec_outcome>
      <sec_outcome>Serum creatinine level. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Enzymatic Kit.</sec_outcome>
      <sec_outcome>Fasting Blood Sugar. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Enzymatic Kit.</sec_outcome>
      <sec_outcome>Hemoglobin A1C. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Turbidimetry.</sec_outcome>
      <sec_outcome>Complete Blood Count(CBC). Timepoint: Before and after 12 weeks of intervention. Method of measurement: Sysmex.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-06</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Sixth Floor, Central Organization of Tehran University of Medical Sciences, Qods St, Keshavarz Blvd,Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
