<?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>IRCT201301263664N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-03-16</date_registration>
      <primary_sponsor>Nutritional Reseach Center of Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effects of fenugreek seeds consumption on metabolic status,serum adiponectin,Hs-CRP &amp; ICAM-1(Intercellular Adhesion Molecule-1) levels in type2 diabetic patients</public_title>
      <acronym></acronym>
      <scientific_title>Effects of fenugreek seeds consumption on metabolic status,serum adiponectin,Hs-CRP &amp; ICAM-1(Intercellular Adhesion Molecule-1) levels in type2 diabetic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3753</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Diabet Mellitus.</hc_freetext>
      <i_freetext>Intervention 1: 10 G of Powdered Fenugreek Seeds Twice a Day - 8 Weeks. Intervention 2: 5 G Starch Twice  a Day- 8 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mina Malekiyan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition School, Attare Neishaboori Avenue, Golgasht Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 42 6223 0227</telephone>
        <email>mina.malekiyan@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mina Malekiyan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition School, Attare Neishaboori Avenue, Golgasht Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 42 6223 0227</telephone>
        <email>mina.malekiyan@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: Volunteered to Participate in The Sudy ؛At Least 6 Months History of Dabetes ؛Use of Blood Sugar Lowering Drugs؛BMI ≤ 35, Women 30-50 Years  and Men Age 30-60، Exclusion Criteria: Pregnancy and lactation ؛Liver Disease،Kidney،Heart Disease،Thyroid Disease،Inflammatory and ... ؛Patients treated with Insulin،Lipid Lowering Drugs، Diuretics،and Use of Detary Supplements،Vitamins and Minerals ؛Hormone Therapy ؛Smoking؛Change in Dose of Oral Hypoglycemic Drugs During The Study ؛Taking Antioxidant Supplements at Least Three Months before the Study and During The Study؛ at Least 6 Weeks Prior to The Intervention Diet Weight Loss</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 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 - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>10 G of Powdered Fenugreek Seeds Twice a Day - 8 Weeks</i_keyword>
      <i_keyword>5 G Starch Twice  a Day- 8 Weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>FBS. Timepoint: Before of Intervention and 8 Weeks After Intervention. Method of measurement: Blood Sampling and Analysing With Spectrophotometer.</prim_outcome>
      <prim_outcome>HbA1C. Timepoint: Before of Intervention and 8 Weeks After Intervention. Method of measurement: Blood Sampling and Analysing With HPLC.</prim_outcome>
      <prim_outcome>Level of Serum Insulin. Timepoint: Before of Intervention and 8 Weeks After Intervention. Method of measurement: Blood Sampling and Analysing With ELISA.</prim_outcome>
      <prim_outcome>HOMA-IR. Timepoint: Before of Intervention and 8 Weeks After Intervention. Method of measurement: Calculated According to The Formula.</prim_outcome>
      <prim_outcome>Total Cholestrol. Timepoint: Before of Intervention and 8 Weeks After Intervention. Method of measurement: Blood Sampling and Analysing With Spectrophotometer.</prim_outcome>
      <prim_outcome>LDL-C. Timepoint: Before of Intervention and 8 Weeks After Intervention. Method of measurement: Calculated According to The Friedwald Formula.</prim_outcome>
      <prim_outcome>HDL-C. Timepoint: Before of Intervention and 8 Weeks After Intervention. Method of measurement: Blood Sampling and Analysing With Immunoturbidimetry.</prim_outcome>
      <prim_outcome>TG. Timepoint: Before of Intervention and 8 Weeks After Intervention. Method of measurement: Blood Sampling and Analysing With Spectrophotometer.</prim_outcome>
      <prim_outcome>Level of Serum Adiponectin. Timepoint: Before of Intervention and 8 Weeks After Intervention. Method of measurement: Blood Sampling and Analysing With ELISA.</prim_outcome>
      <prim_outcome>Level of Serum Hs-CRP. Timepoint: Before of Intervention and 8 Weeks After Intervention. Method of measurement: Blood Sampling and Analysing With Immunoturbidimetry.</prim_outcome>
      <prim_outcome>Level of Serum ICAM-1. Timepoint: Before of Intervention and 8 Weeks After Intervention. Method of measurement: Blood Sampling and Analysing With ELISA.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Vice chancellor for research, Tabriz University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Nutritional Reseach Center of Tabriz University of Medical Sciences</source_name>
      <source_name>Vice chancellor for research, Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-03-02</approval_date>
        <contact_name>The Research Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Attar Neishaboori Avenue, Golgasht Atreet Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
