<?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>IRCT2016042717254N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-11-23</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effects of green cardamom supplementation in type 2 diabetic patients</public_title>
      <acronym></acronym>
      <scientific_title>The effects of green cardamom supplementation on blood pressure and endothelium function,blood glucose indices, lipids, oxidant  and anti oxidant parameters, sirtuin-1, irisin, oxidised LDL, apolipoprotein A1 and B and paraoxonase in type 2 diabetic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-11-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15919</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Randomization description: Using block randomization method, in which the assignment was done based on sex (male/female) and BMI (overweight/ obese). By using stratified randomization participants were matched based on sex and BMI into blocks. Therefore, the block size was 4. By using this method equal number of men and women as well as overweight and obese patients were assigned to green cardamom  and rusk powder group. Random allocation sequence was generated by using Random allocation software: RAS. The allocation process of participants into cardamom and rusk powder groups was done by a third person who was not involved in the project directly, Blinding description: In this study is a a randomized, double-blind, placebo controlled clinical trial. The capsules were labeled as A or B to be delivered to the subjects by a third person who was not involved in the project directly  and had the job to make the supplements. All placebo capsules were placed close to cardamom capsules to take cardamom smell. For doing this, the supplements were safely capsulated. Then a person who was not involved in the study, packaged the two types of supplements in the plastic bags and placed them close together in a covered box. After one week the capsules were packaged in the small containers to be delivered to the subjects. It was tested to see if the placebo capsules took the smells.</study_design>
      <phase>N/A</phase>
      <hc_freetext>diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Green cardamom supplements are prepared as 0.5 gram capsules. 2 capsule per meal (3 gram daily) should be consumed for 10 weeks. Intervention 2: placebo (flour breadcrumbs) supplements are prepared as 0.5 gram capsules. 2 capsule per meal (3 gram daily) should be consumed for 10 weeks.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Gity Sotoudeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 44, Hojjatdoust alley, Naderi St, Keshavarz Beulvard</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417653761</zip>
        <telephone>+98 21 8895 5814</telephone>
        <email>Gsotodeh@tums.ac.ir</email>
        <affiliation>Nutrition and Dietetics Faculty of Tehran Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Gity Sotoudeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition and Dietetics Faculty, Hojjatdoust alley, Naderi St, Keshavarz Beulvard</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417653761</zip>
        <telephone>+98 21 8895 5814</telephone>
        <email>Gsotodeh@tums.ac.ir</email>
        <affiliation>Nutrition and Dietetics Faculty of Tehran Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria Men and women between the age of 30–60 years old who have confirmed diagnosis of type 2 diabetes for more than 2 years; last HbA1C value greater than 7 %; Body Mass Index (BMI) between 25 and 35 kg/m2; Lipid-lowering drugs more than 3 months</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>59 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Exclusion criteria Patients with any of the following criteria will be excluded: being on insulin regimen; use of fibrat(PPAR alpha ligand); TZD (PPAR gamma ligand); Smoking or alcohol consumption at least once a week in the past month; consumption of (at least once a week) herbal supplements; antioxidant; Multivitamin-Mineral in the past 3 months; pregnant and lactating women; have any gastrointestinal disorder, hepatic or renal disease, inflammatory disease, thyroid problems; any Chang in diet during the past 3 months, Consumers of anticoagulants (warfarin , heparin), antiplatelet drugs (Plavix), suppressor CNS (benzodiazepines), barbiturates (phenobarbital), antidepressants.</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>Placebo</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Green cardamom supplements are prepared as 0.5 gram capsules. 2 capsule per meal (3 gram daily) should be consumed for 10 weeks</i_keyword>
      <i_keyword>placebo (flour breadcrumbs) supplements are prepared as 0.5 gram capsules. 2 capsule per meal (3 gram daily) should be consumed for 10 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>FBS. Timepoint: Before intervention, after intervention. Method of measurement: KIT.</prim_outcome>
      <prim_outcome>FPI. Timepoint: Before intervention, after intervention. Method of measurement: KIT.</prim_outcome>
      <prim_outcome>Hg A1c. Timepoint: Before intervention, after intervention. Method of measurement: kit.</prim_outcome>
      <prim_outcome>Lipid profile. Timepoint: Before intervention, after intervention. Method of measurement: kit.</prim_outcome>
      <prim_outcome>TAC. Timepoint: Before intervention, after intervention. Method of measurement: kit.</prim_outcome>
      <prim_outcome>SOD. Timepoint: Before intervention, after intervention. Method of measurement: kit.</prim_outcome>
      <prim_outcome>GPx. Timepoint: Before intervention, after intervention. Method of measurement: kit.</prim_outcome>
      <prim_outcome>MDA. Timepoint: Before intervention, after intervention. Method of measurement: kit.</prim_outcome>
      <prim_outcome>Sirt1. Timepoint: Before intervention, after intervention. Method of measurement: kit.</prim_outcome>
      <prim_outcome>Irisin. Timepoint: Before intervention, after intervention. Method of measurement: kit.</prim_outcome>
      <prim_outcome>VCAM. Timepoint: Befor intervention, after intervention. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>CD-163. Timepoint: Before intervention, after intervention. Method of measurement: kit.</prim_outcome>
      <prim_outcome>ADMA. Timepoint: Befor intervention, after intervention. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>SBP. Timepoint: Before intervention, middle of intervention, after intervention. Method of measurement: mmhg by mercury manometer.</prim_outcome>
      <prim_outcome>OX-LDL. Timepoint: Before intervention, after intervention. Method of measurement: KIT.</prim_outcome>
      <prim_outcome>PON. Timepoint: Before intervention, after intervention. Method of measurement: KIT.</prim_outcome>
      <prim_outcome>Apo A1 - apo B. Timepoint: Before intervention, after intervention. Method of measurement: KIT.</prim_outcome>
      <prim_outcome>ICAM. Timepoint: Befor intervention, after intervention. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>NO. Timepoint: Befor intervention, after intervention. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>TNF-alfa. Timepoint: Befor intervention, after intervention. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>IL-6. Timepoint: Befor intervention, after intervention. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>HsCRP. Timepoint: Befor intervention, after intervention. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>DBP. Timepoint: Befor intervention, middle of intervention,after intervention. Method of measurement: mmhg by mercury manometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-12-13</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>First of Qods, Keshavarz Beulvard tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
