<?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>IRCT201407242602N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-08-22</date_registration>
      <primary_sponsor>Iran University Medical Science</primary_sponsor>
      <public_title>The effect of hesperidin in the treatment of diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Supplementation of  Hesperidin on Serum Glucose,  Insulin, Insulin Resistance, Lipid Profile,  Hemoglobin A1C, hs-CRP and IL6 in Type II Diabetic Mellitus  Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-09-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2381</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>diabet.</hc_freetext>
      <i_freetext>Intervention 1: Hesperidin, Capsules 500 mg, 1 time a day for 2 months. Intervention 2: Starch placebo capsules, 500 mg, 1 time a day for 2 months.</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>Shahryar Eghtesadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hemmat Highway, Iran University of Medical Sciences, School of Public Health</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 218670475</telephone>
        <email>egtesadi@iums.ac.ir, eghtesadi@yahoo.com</email>
        <affiliation>Iran University Medical School</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahryar Eghtesadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hemmat Highway, Iran University of Medical Sciences, School of Public Health</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 218670475</telephone>
        <email>egtesadi@iums.ac.ir, eghtesadi@yahoo.com</email>
        <affiliation>Iran University Medical School</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Being volunteer or Wishing to attend 2.diagnosed with type 2 diabetes for at least 1 year (FPG ≥ 126 mg/dl or 2hPG ≥ 200 mg/dl)3. At least one year history of diabet 4.&#13;
Not using tobacco 5. Lack of cardiovascular disease, liver disease, kidney disease, chronic inflammatory disease of the gastrointestinal tract 6.HbA1C &lt; 8% 7. 20-65 y old 8. Lack of insulin 9.  Not drinking alcohol 10. BMI&lt;35 kg/m2 11. Not using any supplements, antioxidants and vitamins in the last 3 months 12. Not pregnant or nursing 13.TG&lt;400 mg/dl 14. The absence of any skin allergies or digestive antioxidant supplements and vitamins.  Exclusion criteria 1.The use of antioxidant supplements and vitamins 2.Use of insulin 3. See allergy symptoms at any time during the study 4.Taking over500ml beverages rich in flavonoids include tea, coffee, citrus juice, which it is determined by taking the 24-hour dietary recalls 5. Accept less than 70 6. Follow weight loss diets 7.  NSAID nonsteroidal anti-inflammatory drugs and estrogens, oral contraceptives, anticonvulsants, corticosteroids</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Non-insulin-dependent diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Hesperidin, Capsules 500 mg, 1 time a day for 2 months</i_keyword>
      <i_keyword>Starch placebo capsules, 500 mg, 1 time a day for 2 months</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>IL6. Timepoint: After the. Method of measurement: ELISA based on a scale pg / ml.</prim_outcome>
      <prim_outcome>Hs CRP. Timepoint: After the intervention. Method of measurement: ELISA based on a scale ng / ml.</prim_outcome>
      <prim_outcome>Glucose. Timepoint: Before the intervention and after the intervention. Method of measurement: Glucose oxidase method based on scale mg / dl.</prim_outcome>
      <prim_outcome>Insulin. Timepoint: Before the intervention and after the intervention. Method of measurement: ELISA based on a scale μmol / ml.</prim_outcome>
      <prim_outcome>Glycated hemoglobin. Timepoint: Before the intervention and after the intervention. Method of measurement: Chromatography based on the percentage of glycated hemoglobin.</prim_outcome>
      <prim_outcome>TG. Timepoint: Before the intervention and after the intervention. Method of measurement: By an enzymatic method based on the scale mg / dl.</prim_outcome>
      <prim_outcome>TC. Timepoint: Before the intervention and after the intervention. Method of measurement: By an enzymatic method based on the scale mg / dl.</prim_outcome>
      <prim_outcome>LDL. Timepoint: Before the intervention and after the intervention. Method of measurement: To help Frydvald formula based on mg / dl.</prim_outcome>
      <prim_outcome>HDL. Timepoint: Before the intervention and after the intervention. Method of measurement: By an enzymatic method based on the scale mg / dl.</prim_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: Before the intervention and after the intervention. Method of measurement: Using a pressure gauge based on a scale mm Hg.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: Before the intervention and after the intervention. Method of measurement: Using a pressure gauge based on a scale mm Hg.</prim_outcome>
      <prim_outcome>Insulin Resistance. Timepoint: Before the intervention and after the intervention. Method of measurement: Using the formula.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Age. Timepoint: Before the intervention and after the intervention. Method of measurement: Using Balance 0/1kg carefully based on kg scale.</sec_outcome>
      <sec_outcome>BMI. Timepoint: Before the intervention and after the intervention. Method of measurement: Using the formula.</sec_outcome>
      <sec_outcome>Physical activity. Timepoint: Before the intervention and after the intervention. Method of measurement: Using a questionnaire, based on three levels of light, medium and heavy.</sec_outcome>
      <sec_outcome>Dietary intake. Timepoint: Before the intervention and after the intervention. Method of measurement: based on a 3-day recall measure kcal.</sec_outcome>
      <sec_outcome>Gender. Timepoint: before the intervention. Method of measurement: Using view on men or women.</sec_outcome>
      <sec_outcome>Types of drugs. Timepoint: Before the intervention and after the intervention. Method of measurement: Using a questionnaire based on observation.</sec_outcome>
      <sec_outcome>Dose of drugs. Timepoint: Before the intervention and after the intervention. Method of measurement: Using a questionnaire based on the number of.</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>Iran University Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-07-14</approval_date>
        <contact_name>School of Public Health, Iran University of Medical Sciences</contact_name>
        <contact_address>Hemmat Highway, Iran University of Medical Sciences Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
