<?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>IRCT20120704010181N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-12</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of dill  powder on the treatment of type 2 diabetic patients</public_title>
      <acronym></acronym>
      <scientific_title>Assessment of the effect of dill powder on gastrointestinal symptoms, glycemic control, lipid profile, serum levels of oxidant and Inflammatory markers in type 2 diabetic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29037</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple (assigning a person to a particular group completely randomly) using a random number table, Blinding description: In this double blind study neither the patients nor researcher the treatment know which capsules are being received. In fact, a third person who knows the contents of the capsules distributes supplements among the participants. The shape, size and color of the capsules are similar in both groups, while their content is different.</study_design>
      <phase>3</phase>
      <hc_freetext>diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Dill powder, 1 gram , three capsule per day for 8 weeks. Intervention 2: placebo, 1 gram , three capsule per day for 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is it is not the objective of this study.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Golnaz Amoohi Foroushani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Highway</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+98 61 3221 1503</telephone>
        <email>Golnazamoochi@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Haidari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Highway</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+98 61 3373 8317</telephone>
        <email>haidari-f@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with type 2 diabetic
Body mass index between 25-35
Age between 30-60 years
Desire to collaborate on the research project</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having other endocrine diseases, cardiovascular, liver, kidney, thyroid
Taking steroids or hormone medications, consumption vitamin , herbal, mineral or, antioxidants supplements  in the last three months
Having physical activity
Weight loss diet
pregnancy
lactation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>,E10-E14</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Dill powder, 1 gram , three capsule per day for 8 weeks</i_keyword>
      <i_keyword>placebo, 1 gram , three capsule per day for 8 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fasting Glucose. Timepoint: baseline, 8 weeks after intervention period. Method of measurement: Fasting serum Glucose concentration in mg/dl by kit.</prim_outcome>
      <prim_outcome>Serum levels of insulin. Timepoint: baseline, 8 weeks after intervention period. Method of measurement: Fasting serum Insulin concentration in µU/ml by kit.</prim_outcome>
      <prim_outcome>Serum Fructosamine. Timepoint: baseline, 8 weeks after intervention period. Method of measurement: Fasting serum Fructosamine concentration in µmol/L by kit.</prim_outcome>
      <prim_outcome>Serum cholestrol. Timepoint: baseline, 8 weeks after intervention period. Method of measurement: Fasting Serum cholestrol concentration in mg/dl by kit.</prim_outcome>
      <prim_outcome>LDL Cholestrol. Timepoint: baseline, 8 weeks after intervention period. Method of measurement: Fasting Serum HDL Cholestrol concentration in mg/dl, calculating by Friedewald formula.</prim_outcome>
      <prim_outcome>HDL Cholestrol. Timepoint: baseline, 8 weeks after intervention period. Method of measurement: Fasting Serum HDL Cholestrol concentration in mg/dl by kit.</prim_outcome>
      <prim_outcome>Serum Teriglycerid. Timepoint: baseline, 8 weeks after intervention period. Method of measurement: Fasting serum Teriglycerid concentration in mg/dl by kit.</prim_outcome>
      <prim_outcome>Hs- CRP. Timepoint: baseline, 8 weeks after intervention period. Method of measurement: serum hs- CRP concentration in mg/L by kit.</prim_outcome>
      <prim_outcome>Serum malondialdehyde. Timepoint: baseline, 8 weeks after intervention period. Method of measurement: Fasting serum malondialdehyde concentration in µmol/ml by kit.</prim_outcome>
      <prim_outcome>Total Antioxidant Capacity. Timepoint: baseline, 8 weeks after intervention period. Method of measurement: Fasting serum Total Antioxidant Capacity in U/ml by kit.</prim_outcome>
      <prim_outcome>Gastrointestinal symptoms. Timepoint: baseline, 8 weeks after intervention period. Method of measurement: Using the questionnaire by percentage.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Body Mass Index. Timepoint: baseline, 8 weeks after intervention period. Method of measurement: body weight / hight square (kg/m2).</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-11-20</approval_date>
        <contact_name>Ethics Committee of Ahwaz University of Medical Sciences</contact_name>
        <contact_address>Golestan Highway ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
