<?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>IRCT201008224612N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-04-30</date_registration>
      <primary_sponsor>the International  Branch of Shahid Beheshti University of Medical Sciences &amp; Health Services</primary_sponsor>
      <public_title>The effect of sour tea (Hibiscus sabdariffa L.) on the lipid</public_title>
      <acronym></acronym>
      <scientific_title>The effect of sour tea consumption (Hibiscus sabdariffa L.) on the lipid profile in dyslipidemic subjects</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4925</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>polygenic Dyslipidemia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The Intervention group will receive lifestyle modification education at baseline and then consume two cups of sour tea extract daily between morning and evening meals for 90 days (each time, add two teaspoons (2 grams) of pulverized sour tea in one glass of boiling water (240 ml) for 30 minutes, and take it with a sugar cube (3 grams)). Intervention 2: Control group: The Control group will receive lifestyle modification education at baseline only and do not consume sour tea.</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>Farihe  Ahmadzadeh Sani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gonabad  University of Medical Sciences, Food and Drug Administration, Ghadir Square</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9691699967</zip>
        <telephone>+98 53 3722 1929</telephone>
        <email>farihe_ahmadzadeh1384@gmu.ac.ir</email>
        <affiliation>the International  Branch of Shahid Beheshti University of Medical Sciences &amp; Health Services</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farihe  Ahmadzadeh Sani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gonabad  University of Medical Sciences, Food and Drug Administration, Ghadir Square</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9691699967</zip>
        <telephone>+98 53 3722 1929</telephone>
        <email>farihe_ahmadzadeh1384@gmu.ac.ir</email>
        <affiliation>the International Branch of Shahid Beheshti University of Medical Sciences &amp; Health Services</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Polygenic dyslipidemia as defined; not intaking lipid lowering drugs Exclusion criteria: allergy to tea; not interested in consuming tea; take a trip; having other diseases such as familial dyslipidemia; diabetes; cardiovascular disease; kidney and liver diseases</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E78.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mixed hyperlipidaemia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The Intervention group will receive lifestyle modification education at baseline and then consume two cups of sour tea extract daily between morning and evening meals for 90 days (each time, add two teaspoons (2 grams) of pulverized sour tea in one glass of boiling water (240 ml) for 30 minutes, and take it with a sugar cube (3 grams)).</i_keyword>
      <i_keyword>Control group: The Control group will receive lifestyle modification education at baseline only and do not consume sour tea.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Total cholesterol. Timepoint: Baseline, six weeks and twelve weeks after intervention. Method of measurement: Cholesterol oxidase enzymatic method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>LDL-C. Timepoint: Baseline, six weeks and twelve weeks after intervention. Method of measurement: Fridvald is calculated using the formula.</sec_outcome>
      <sec_outcome>HDL-c. Timepoint: Baseline, six weeks and twelve weeks after intervention. Method of measurement: Cholesterol oxidase enzymatic method.</sec_outcome>
      <sec_outcome>Triglyceride. Timepoint: Baseline, six weeks and twelve weeks after intervention. Method of measurement: Glycerol oxidase enzymatic methods.</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>the International  Branch of Shahid Beheshti University of Medical Sciences &amp; Health Services</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-01-01</approval_date>
        <contact_name>Medical Ethics Committee of the International  Branch of Shahid Beheshti University of Medical Scien</contact_name>
        <contact_address>19 Shahid Abbaspour St., Vali-Asr Ave., the International Branch of Shahid Beheshti University of Medical Sciences &amp; Health Services Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
