<?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>IRCT2014121920366N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-02-14</date_registration>
      <primary_sponsor>Vice chancellor for research,Isfahan University of Medical Science</primary_sponsor>
      <public_title>The Effects of Portulaca oleracea Extract capsule on inflammatory biomarkers, lipid profile and serum glucose, anthropometric indices and blood pressure</public_title>
      <acronym></acronym>
      <scientific_title>The Effects of Portulaca oleracea Extract capsule on inflammatory biomarkers, lipid profile and serum glucose, anthropometric indices and blood pressure  in adult with Metabolic syndrome for prevention of heart disease.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-04-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18064</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: Making Purslane extract capsule: Purslane Confirmed in the Department of Pharmacognosy , Faculty of Pharmacy, then, 20 kg of plants dried in the shade , with 150 liters of ethanol  with maceration method for 4 days extraction was repeated three times. The extract was filtered through filter paper using a rotary evaporator ( Haydolf , Germany ) under the pressure of a vacuum pump with a pressure of 10 mbar and a temperature of 40 ° C Was solved. The concentrated extract mixtured with anhydrous calcium phosphate powder (di calcium phosphate), and then through a sieve size 20 (850/0 mm) was granulated and dried at 40 ° C. The dried granules were sifting with sieve size 20 again. Finally purslane capsules were made granules containing dried extract of Portulaca oleracea extract as much as 500 mg per capsule at the Isfahan School Pharmacy.</study_design>
      <phase>1</phase>
      <hc_freetext>Metabolic syndrome.</hc_freetext>
      <i_freetext>Intervention 1: intervention group consume Purslane extract capsules. Two capsules 500 mg , one  30 minutes before breakfast and another 30 minutes before dinner. Intervention 2: control group consume placebo capsule for 2 months. 1 capsule 30 minutes before breakfast and 1 capsule 30 minutes  before dinner. Placebo was made ​​of calcium phosphate.</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>Marjan  Badakhanian</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 3792 2752</telephone>
        <email>marjanbadakhanian@ymail.com</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marjan Badakhanian</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 3792 2752</telephone>
        <email>marjanbadakhanian@ymail.com</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: persons suffering from obesity as defined by the IDF (WC≥ 102 in men) and have 2 signs of the 4 following symptoms, the metabolic syndrome was diagnosed.  In this study, the characteristics of metabolic syndrome will be considered, if the criteria were the terms of this syndrome (having 2 of the first 4), other criteria will be checked:&#13;
1-high blood pressure (systolic&gt;130mhg and diastolic&gt;85mmhg); 2-fasting blood glucose&gt;100mg/dl; 3-TG&gt;150mg/dl; 4-HDL&lt;40mg/dl; -gender: male; no history of cancer, kidney, thyroid, diabetes, and anemia; lack of use of alcohol and drugs; no smoking history or drug allergy;  no special diet; no change in medication in the last three months; lack of drugs that control blood sugar, lipid and blood pressure; no taking medications affecting inflammation, such as corticosteroids.&#13;
Exclusion criteria: during the study , patients who lose their inclusion criteria, including smoking; suffering from diseases such as heart problems , kidney , thyroid and digestive disorders and lack of cooperation.</inclusion_criteria>
      <agemin>27 years</agemin>
      <agemax>59 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group consume Purslane extract capsules. Two capsules 500 mg , one  30 minutes before breakfast and another 30 minutes before dinner.</i_keyword>
      <i_keyword>control group consume placebo capsule for 2 months. 1 capsule 30 minutes before breakfast and 1 capsule 30 minutes  before dinner. Placebo was made ​​of calcium phosphate</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum high sensitive-C Reactive Protein (hs-CRP) levels. Timepoint: In the first of intervention and end of 8th week. Method of measurement: mg/l-imonotorbidometry.</prim_outcome>
      <prim_outcome>NON-HDL CHOL. Timepoint: In the first of intervention and end of 8th week. Method of measurement: Calculation method.</prim_outcome>
      <prim_outcome>Waist circumference. Timepoint: In the first of intervention and end of 8th week. Method of measurement: meter, centimeter.</prim_outcome>
      <prim_outcome>Weight. Timepoint: In the first of intervention and end of 8th week. Method of measurement: scale, kilogram.</prim_outcome>
      <prim_outcome>Body mass index. Timepoint: In the first of intervention and end of 8th week. Method of measurement: kg/m2, Weight/Height square.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: In the first of intervention and end of 8th week. Method of measurement: mmHg, Mercurial sphygmomanometer.</prim_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: In the first of intervention and end of 8th week. Method of measurement: mmHg, Mercurial sphygmomanometer.</prim_outcome>
      <prim_outcome>Fasting blood sugar. Timepoint: In the first of intervention and end of 8th week. Method of measurement: Enzymatic, mg/dL.</prim_outcome>
      <prim_outcome>Serum total cholesterol levels. Timepoint: In the first of intervention and end of 8th week. Method of measurement: Enzymatic, mg/dL.</prim_outcome>
      <prim_outcome>Serum High-Density Lipoprotein cholesterol (HDL-c) levels. 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: In the first of intervention and end of 8th week. Method of measurement: Calculation method.</prim_outcome>
      <prim_outcome>Fibrinogen. Timepoint: In the first of intervention and end of 8th week. Method of measurement: Clauss  method.</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 Jerib Avenue Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
