<?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>IRCT20171220037971N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-09</date_registration>
      <primary_sponsor>Bandare-abbas University of Medical Sciences</primary_sponsor>
      <public_title>Therapeutic effect of chicory in type 2 diabetic patients</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of therapeutic effect of Cichorium intybus in patients with type 2 diabetes: a randomized double blind clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28582</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling method at this study will be according to random allocation. Participants will enter the study according to inclusion criteria, and then will be divided into two groups according to randomization table. One group will receive chicory (powder of whole plant within capsules) and the other will receive placebo (Maltodextrin within capsules). The participants and administrator do not have any information about content of capsules (double blinded study), Blinding description: The identical capsules will be separated into 2 groups by corresponding author: group 1 and group 2. Just the corresponding author knows about content of the capsules, and during the intervention period she doesn't have any contact with participants or administrators. The persons who collect data don't have any information about content of the capsules. Participants do not have any information about content of the capsules because the shape and color of capsules are identical. All analyses will be performed just using codes: group 1 and 2. At the end of assessment the contents of capsules will be revealed by the corresponding author.</study_design>
      <phase>3</phase>
      <hc_freetext>Type 2 diabetes mellitus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group in this research will receive whole chicory plant powder. Participants take 3 gr chicory powder daily as 6 capsules and take them 2 times a day after breakfast and dinner. This herb will be bought and packaged in Tehran Faculty of Pharmacy. Intervention 2: Control group: The placebo group in this research will receive Maltodextrin. Participants take 3 gr Maltodextrin daily as 6 capsules and take them 2 times a day after breakfast and dinner. This compound will be Bought and packaged in Tehran Faculty of Pharmacy.</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 There is no more data available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Hendijani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Pharmacy and Pharmaceutical Sciences, Opposite the Sports Club of Workers, Imam Hossein Blvd, Bandar abbas</address>
        <city>Bandar abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7919691982</zip>
        <telephone>+98 76 3371 0405</telephone>
        <email>f_hendijani@pharm.mui.ac.ir</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Hendijani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Pharmacy and Pharmaceutical Sciences, Opposite the Sports Club of Workers, Imam Hossein Blvd, Bandar abbas</address>
        <city>Bandar abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7919691982</zip>
        <telephone>+98 76 3371 0405</telephone>
        <email>f_hendijani@pharm.mui.ac.ir</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patients with type 2 diabetes (T2DM)
age from 30 to 65 years
BMI less than 30kg / m ^ 2
They have been diagnosed for diabetes at least one year before entering into the study
Taking anti-diabetes drugs (the type of medicine is not a criterion)
not using insulin</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Addiction to alcohol and drugs
Abnormal level of liver enzymes or BUN or creatinine
Any change in the type, or dosage of antidiabetic drugs or administration of insulin
The presence of special diseases or condition (eg, nephropathy, thyroid disease, pregnancy, etc.)
Taking medications that affect blood sugar levels
Failure to follow the study protocol</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 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>Intervention group: The intervention group in this research will receive whole chicory plant powder. Participants take 3 gr chicory powder daily as 6 capsules and take them 2 times a day after breakfast and dinner. This herb will be bought and packaged in Tehran Faculty of Pharmacy.</i_keyword>
      <i_keyword>Control group: The placebo group in this research will receive Maltodextrin. Participants take 3 gr Maltodextrin daily as 6 capsules and take them 2 times a day after breakfast and dinner. This compound will be Bought and packaged in Tehran Faculty of Pharmacy.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fasting blood glucose. Timepoint: investigate fasting blood glucose at the first and end of research. Method of measurement: Autoanalyzer spectrophotometer.</prim_outcome>
      <prim_outcome>Hemoglobin A1c. Timepoint: investigate Hemoglobin A1c  at the first and end of research. Method of measurement: Autoanalyzer spectrophotometer.</prim_outcome>
      <prim_outcome>Homeostatic Model Assessment of Insulin Resistance. Timepoint: investigate Homeostatic Model Assessment of Insulin Resistance  at the first and end of research. Method of measurement: Autoanalyzer spectrophotometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Serum level of triglyceride. Timepoint: investigate serum level of triglyceride at the first and end of research. Method of measurement: Autoanalyzer spectrophotometer.</sec_outcome>
      <sec_outcome>Serum level of total cholesterol. Timepoint: investigate serum level of total cholesterol at the first and end of research. Method of measurement: Autoanalyzer spectrophotometer.</sec_outcome>
      <sec_outcome>Serum level of low density lipoprotein cholesterol. Timepoint: investigate serum level of low density lipoprotein cholesterol at the first and end of research. Method of measurement: Autoanalyzer spectrophotometer.</sec_outcome>
      <sec_outcome>Serum level of high density lipoprotein cholesterol. Timepoint: investigate serum level of high density lipoprotein cholesterol at the first and end of research. Method of measurement: Autoanalyzer spectrophotometer.</sec_outcome>
      <sec_outcome>Serum level of Aspartate Aminotransferase. Timepoint: investigate serum level of Aspartate Aminotransferase  at the first and end of research. Method of measurement: Autoanalyzer spectrophotometer.</sec_outcome>
      <sec_outcome>Serum level of Alanine Aminotransferase. Timepoint: investigate serum level of Alanine Aminotransferase at the first and end of research. Method of measurement: Autoanalyzer spectrophotometer.</sec_outcome>
      <sec_outcome>Serum level of alkaline phosphatase. Timepoint: investigate serum level of alkaline phosphatase at the first and end of research. Method of measurement: Autoanalyzer spectrophotometer.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: investigate blood pressure at the first and end of research. Method of measurement: The mercury manometer.</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>Bandare-abbas University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-04-29</approval_date>
        <contact_name>Ethics committee of Hormozgan University of Medical Sciences</contact_name>
        <contact_address>Payambar Aazam Medical and Educational complex, Kuy e Farhangiyan, Bandar Abbas, Hormozgan Province Bandar-abbas Hormozgan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
