<?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>IRCT2015020720986N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-03-07</date_registration>
      <primary_sponsor>Vice chancellor for research, Isfahan University of Medical Science</primary_sponsor>
      <public_title>Effect of mixed of garlic and lemon juice on hyperlipidemia</public_title>
      <acronym></acronym>
      <scientific_title>Effect of garlic and lemon juice mixture on lipid profile and some cardiovascular risk factors in people 30-60 years old with hyperlipidemia.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18510</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hyperlipidemia.</hc_freetext>
      <i_freetext>Intervention 1: first group  received 20 grams of garlic  plus 1 tablespoon lemon juice daily. Intervention 2: forth group did not recive garlic and lemon juice during the intervention. Intervention 3: second group recived 20 gram of garlic, daily. Intervention 4: third group recived 1 tablespoon of lemon juice, daily.</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>Negar Aslani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Clinical nutrition, School of Nutrition and Food Sciences, Isfahan University of Medical Scienses, Hezar Jerib street, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3433 2929</telephone>
        <email>negar_aslani@nutr.mui.ac.ir; negaraslani5@yahoo.com</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Negar Aslani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department Of clinical Nutrition, School Of Nutrition and Food Sciences, Isfahan University Of Medical Sciences, Hezar Jerib Street, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3433 2929</telephone>
        <email>negar_aslani@nutr.mui.ac.ir; negaraslani5@yahoo.com</email>
        <affiliation>Isfahan university of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Subjects were eligible if they have a total cholesterol and LDL levels between 240-200 mmol/l and 160-100 mmol/l respectively. People should not be suffering from any other diseases, including heart problems, kidney, lung, thyroid disorders, gastrointestinal, rheumatoid arthritis and other liver problems such as hepatitis or fatty liver, pregnancy or lactating, no smoking, their weight may not change fast in the last two months, should not use drugs that affect blood sugar, blood fat, blood pressure and anti-inflammatory and not to have any sensitivity to garlic and lemon juice. Individual with a history of chronic disease, consuming medicine and flowing special regimen were excluded.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E78.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disorders of lipoprotein metabolism and other lipidaemias</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>first group  received 20 grams of garlic  plus 1 tablespoon lemon juice daily</i_keyword>
      <i_keyword>forth group did not recive garlic and lemon juice during the intervention</i_keyword>
      <i_keyword>second group recived 20 gram of garlic, daily</i_keyword>
      <i_keyword>third group recived 1 tablespoon of lemon juice, daily</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Total cholesterol. Timepoint: in the first of  intervention and end of 8th week. Method of measurement: enzymatic, mg/dl.</prim_outcome>
      <prim_outcome>Serum low-density lipoprotein cholesterol (LDL-C) levels. Timepoint: Before intervention and at the end of 8th week. Method of measurement: Enzymatic, mg/dl.</prim_outcome>
      <prim_outcome>Serum hight-density lipoprotein cholesterol (HDL-C) levels. Timepoint: Before intervention and at the end of 8th week. Method of measurement: Enzymatic, mg/dl.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: in the first of  intervention and end of 8th week. Method of measurement: Enzyme colorimetric methods, mg/dl.</prim_outcome>
      <prim_outcome>Fibrinogen. Timepoint: Before intervention and at the end of 8th week. Method of measurement: Clauss method.</prim_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: Before intervention and at the end of 8th week. Method of measurement: mmHg, Mercurial sphygmomanometer.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: Before intervention and at the end of 8th week. Method of measurement: mmHg, Mercurial sphygmomanometer.</prim_outcome>
      <prim_outcome>Body mass index. Timepoint: Before intervention and at the end of 8th week. Method of measurement: kg/m2, Weight/Height squar.</prim_outcome>
      <prim_outcome>Fasting blood sugar. Timepoint: Before intervention and at the end of 8th week. Method of measurement: Enzymatic, mg/dl.</prim_outcome>
      <prim_outcome>Weight. Timepoint: Before intervention and at the end of 8th week. Method of measurement: Scale, kilogram.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Isfahan University of Medical Sciences, School of Nutrition-School Nutrition Research Center</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, Isfahan University of Medical Science</source_name>
      <source_name>Isfahan University of Medical Sciences, School of Nutrition-School Nutrition Research Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-10-28</approval_date>
        <contact_name>Ethical Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan University of Medical Sciences, Hezar jarib street Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
