<?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>IRCT20151128025274N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-30</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The effects of rutin flavonoid on type 2 diabetes mellitus</public_title>
      <acronym></acronym>
      <scientific_title>The effects of rutin flavonoid supplement on glycemic status, lipid profile, plasma atherogenic index, brain derived neurotropic factor (BDNF), some serum inflammatory biomarkers and oxidative stress in patients with type 2 diabetes mellitus</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53180</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Based on inclusion criteria, 50 patients will randomly allocated to placebo (n = 25) or intervention (n = 25) groups. Block design based on the combined analysis and using packed envelopes is used for randomization. In fact, according to pattern and using two codes of A and B 6 groups with 4 blocks are selected. This work is repeated in 2 steps. At the end, two A and B codes are assigned to the 2 last patients and the randomization is completed (50 patients). (step1; AABB, BBAA, ABAB, BABA, ABBA, BABA, step2; AABB, BBAA, ABAB, BABA, ABBA, BABA and AB), Blinding description: The researchers and patients will not informed of the contents of the packets. A third person of health care does the coding. This person will not
 aware of the details of the research trial.</study_design>
      <phase>2</phase>
      <hc_freetext>Type 2 diabetes mellitus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Every day, one tablet of 1 g rutin (containing 500 mg of pure rutin and 500 mg other compounds include di-calcium phosphate, microcrystalline cellulose, plant cellulose, stearic acid, magnesium stearic, silica, glycerin), made by the Solgar company, USA, after meals for 90 days. Intervention 2: Control group: One tablet of 1 g placebo/day (containing compound similar to supplement except rutin), made by the Faculty of Pharmacy of Ahvaz Jundishapur University of Medical Sciences, in terms of shape, color, size similar to supplement, after meals for 90 days.</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 The person's information will be confidential and the results will be as collective statistics</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hadi Bazyar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Nutrition, School of Allied Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan St., Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7853167465</zip>
        <telephone>+98 61 3333 0747</telephone>
        <email>hadibazyar2015@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ahmad Zare Javid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Nutrition, School of Allied Medical Sciences, Jundishapur University of Medical Sciences, Golestan St., Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6163764754</zip>
        <telephone>+98 74 3333 1257</telephone>
        <email>ahmaddjavid@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
People between 20 to 60 years old in both sexes
Over at least 2 years from time of diagnosis of  type 2 diabetes mellitus
Body mass index (BMI) less than 35 (BMI ≤ 35)
Glycosylated hemoglobin (HbA1c) between 6.5 to 11%</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reluctance of patients to participate in the study
Developing complications from diabetes such as kidney failure
Diabetic patients taking insulin
Thyroid disease
Anemia
Pregnancy, lactation
Traveling more than 2 weeks
Smokers
Use of other dietary supplements, probiotics and anti-inflammatory drugs
Use of any antioxidant supplements in the last 3 months
Use of immunosuppressive drugs
Following of special diets other than the diet specific to diabetic patients
Change of diet or decide to lose weight</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 - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Every day, one tablet of 1 g rutin (containing 500 mg of pure rutin and 500 mg other compounds include di-calcium phosphate, microcrystalline cellulose, plant cellulose, stearic acid, magnesium stearic, silica, glycerin), made by the Solgar company, USA, after meals for 90 days.</i_keyword>
      <i_keyword>Control group: One tablet of 1 g placebo/day (containing compound similar to supplement except rutin), made by the Faculty of Pharmacy of Ahvaz Jundishapur University of Medical Sciences, in terms of shape, color, size similar to supplement, after meals for 90 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fasting blood sugar. Timepoint: Before and after the intervention. Method of measurement: Using enzymatic kit method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Insulin. Timepoint: Before and after the intervention. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>HbA1C. Timepoint: Before and after the intervention. Method of measurement: By HPLC method and with Ds5 device.</sec_outcome>
      <sec_outcome>HOMA -IR. Timepoint: Before and after the intervention. Method of measurement: [FPG (mmol / l x FPI (FIU/ml)] / 22.5.</sec_outcome>
      <sec_outcome>QUICKi. Timepoint: Before and after the intervention. Method of measurement: 1 / [log (I0) + log (G0)] ISQUICKi.</sec_outcome>
      <sec_outcome>Plasma atherogenic index. Timepoint: Before and after the intervention. Method of measurement: log TG/HDL.</sec_outcome>
      <sec_outcome>HDL-c. Timepoint: Before and after the intervention. Method of measurement: Using enzymatic kit method.</sec_outcome>
      <sec_outcome>Triglyceride. Timepoint: Before and after the intervention. Method of measurement: Using enzymatic kit method.</sec_outcome>
      <sec_outcome>LDL.C. Timepoint: Before and after the intervention. Method of measurement: Using enzymatic kit method.</sec_outcome>
      <sec_outcome>Total cholestrol. Timepoint: Before and after the intervention. Method of measurement: Using enzymatic kit method.</sec_outcome>
      <sec_outcome>IL-6. Timepoint: Before and after the intervention. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>TAC. Timepoint: Before and after the intervention. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>MDA. Timepoint: Before and after the intervention. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>BDNF. Timepoint: Before and after the intervention. Method of measurement: ELISA.</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>2020-12-26</approval_date>
        <contact_name>The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan,Iran Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
