<?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>IRCT2017102022689N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-11-05</date_registration>
      <primary_sponsor>Vice chancellor for research and technology, Tehran university of medical sciences</primary_sponsor>
      <public_title>The effect of Cynara Scolymus on hyperlipidemia</public_title>
      <acronym></acronym>
      <scientific_title>To determine the effectiveness of Cynara Scolymus extract on lipid profile of hemodialysis  patients compared with placebo</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19517</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>End stage renal disease.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, the samples receive artichoke capsules ( 320 mg) up to 6 weeks twice daily ( 8 am and 8 pm ). All samples in both intervention and control groups, routinely receive atorvastatin tablets and low salt diet. The samples will be asked not to change in their diet and physical activity during this study and inform researchers about any changes in their medications. Intervention 2: In the placebo group, the samples receive placebo capsule containing starch ( 320 mg) up to 6 weeks twice daily ( 8 am and 8 pm ). All samples in both intervention and control groups, routinely receive atorvastatin tablets and low salt diet. The samples will be asked not to change in their diet and physical activity during this study and inform researchers about any changes in their medications.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ebrahim Khadem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vice chancellor for student in Tehran university of medical science , building 43 , No. 21 , Fardanesh Alley , Ghods street , Keshavarz boulevard</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417733161</zip>
        <telephone>+98 21 8897 4638</telephone>
        <email>Dr.Ebrahimkhadem@yahoo.com</email>
        <affiliation>School of traditional medicine Tehran university of medical sciences ,Vice chancellor for student in</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyyed mansour Gatmiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nephrology research center , Imam Khomeini hospital complex , the end of Keshavarz blvd.</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 6119 2679</telephone>
        <email>gatmiri@tums.ac.ir</email>
        <affiliation>Tehran university of medical science ,Imam Khomeini hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Entry criteria:History of hyperlipidemia in  hemodialysis patient; with failure to control blood lipids (serum LDL ≥100 mg/dl );with Age over 18 and under 70 years old;with dialysis 2-3 time weekly every times for 3-4 hours;with The patient's willingness to participate in the research;having a case in considered nephrology center&#13;
without exclusion criteria;BMI less than 18;Artichoke use at least one month before the start of the study; unwillingness to continue to cooperate or traveling or death; pregnancy and lactation; the development of side effects of drug; lack of medication over a week.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N17,N19</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>End stage kidney disease: in allograft failure NOS on dialysis or without dialysis or transplant , Renal retinitis , Uraemic: apoplexia+ , dementia+ , neuropathy+ , paralysis+ , pericarditis</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>In the intervention group, the samples receive artichoke capsules ( 320 mg) up to 6 weeks twice daily ( 8 am and 8 pm ). All samples in both intervention and control groups, routinely receive atorvastatin tablets and low salt diet. The samples will be asked not to change in their diet and physical activity during this study and inform researchers about any changes in their medications.</i_keyword>
      <i_keyword>In the placebo group, the samples receive placebo capsule containing starch ( 320 mg) up to 6 weeks twice daily ( 8 am and 8 pm ). All samples in both intervention and control groups, routinely receive atorvastatin tablets and low salt diet. The samples will be asked not to change in their diet and physical activity during this study and inform researchers about any changes in their medications.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum LDL concentration. Timepoint: At baseline and at the end of 4 and 8 weeks of study. Method of measurement: Special kits.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Serum triglyceride concentrations. Timepoint: At baseline and at the end of 4 and 8 weeks of study. Method of measurement: Special kits.</sec_outcome>
      <sec_outcome>Serum HDL concentrations. Timepoint: At baseline and at the end of 4 and 8 weeks of study. Method of measurement: Special kits.</sec_outcome>
      <sec_outcome>Serum cholestrol concentrations. Timepoint: At baseline and at the end of 4 and 8 weeks of study. Method of measurement: Special kits.</sec_outcome>
      <sec_outcome>Serum CRP concentrations. Timepoint: At baseline and at the end of 4 and 8 weeks of study. Method of measurement: Special kits.</sec_outcome>
      <sec_outcome>Serum ESR concentrations. Timepoint: At baseline and at the end of 4 and 8 weeks of study. Method of measurement: Special kits.</sec_outcome>
      <sec_outcome>Serum ferritin concentrations. Timepoint: At baseline and at the end of 4 and 8 weeks of study. Method of measurement: Special kits.</sec_outcome>
      <sec_outcome>Serum iron concentrations. Timepoint: At baseline and at the end of 4 and 8 weeks of study. Method of measurement: Special kits.</sec_outcome>
      <sec_outcome>Serum TIBC concentrations. Timepoint: At baseline and at the end of 4 and 8 weeks of study. Method of measurement: Special kits.</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>Vice chancellor for research and technology, Tehran university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-12-13</approval_date>
        <contact_name>The ethics committee of Tehran university of medical sciences</contact_name>
        <contact_address>Sixth floor, , central building of the Tehran university of medical sciences , Ghods street , Keshavarz blvd Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
