<?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>IRCT20090609002017N24</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-12-21</date_registration>
      <primary_sponsor>Nutritional Research Center</primary_sponsor>
      <public_title>Saffron effect on pancreatic beta cell pyroptosis in patients with type 2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Association between saffron supplementation and metabolic factors, serum oxidative stress indices and gene expression rate of pyroptosis related inflammatory factors in patients with type 2 diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1643</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization will be used for each person by random numbers. due to proper allocation concealment, trial investigators and participants will be unaware of upcoming allocations, Blinding description: This is a double-blind study and both of the patients and researcher will be blind to group allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Saffron powder, 50 mg capsule, 2 per day, for 2 months. Intervention 2: Starch and dextrose powder, 50 mg capsule, 2 per day, for 2 months.</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 All data are resulting from dissertation and will be used just for manuscript printing in academic journals.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Aynaz Seyed Tajaddini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition Faculty,  Attar Neishaburi Ave, Golgasht Ave</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5157743856</zip>
        <telephone>+98 41 3331 5579</telephone>
        <email>tajaddinia@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Ostadrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition Faculty, Attar Neishaburi Ave, Golgasht Ave</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 2295</telephone>
        <email>ostadrahimi@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Tendency to attend in study
Subjects with T2D
Males and females aged 20-60 years
BMI 25-35 kg/m2
Not on insulin therapy</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Not tendency to attend in study
Suffering from chronic inflammatory disorders, renal or hepatic disease
Consuming NSAIDs, steroids or hormonal drugs
Any change in type or dosage of drugs
Any change in diet or physical activity during the running period
Smoking
Subjects needed to start insulin therapy during intervention
Pregnancy or lactation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Non-insulin dependent diabetes</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Saffron powder, 50 mg capsule, 2 per day, for 2 months</i_keyword>
      <i_keyword>Starch and dextrose powder, 50 mg capsule, 2 per day, for 2 months</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Expression rate of TLR-4. Timepoint: before and 2 months after the intervention. Method of measurement: RT-PCR.</prim_outcome>
      <prim_outcome>Expression rate of NLRP3. Timepoint: before and 2 months after the intervention. Method of measurement: RT-PCR.</prim_outcome>
      <prim_outcome>Expression rate of TXNIP. Timepoint: before and 2 months after the intervention. Method of measurement: RT-PCR.</prim_outcome>
      <prim_outcome>Expression rate of Caspase-1. Timepoint: before and 2 months after the intervention. Method of measurement: RT-PCR.</prim_outcome>
      <prim_outcome>Expression rate of IL-1β. Timepoint: before and 2 months after the intervention. Method of measurement: RT-PCR.</prim_outcome>
      <prim_outcome>Expression rate of IL-18. Timepoint: before and 2 months after the intervention. Method of measurement: RT-PCR.</prim_outcome>
      <prim_outcome>Fasting Blood Glucose. Timepoint: before and 2 months after the intervention. Method of measurement: Enzymatic glucose oxidase method.</prim_outcome>
      <prim_outcome>HOMA-IR. Timepoint: before and 2 months after the intervention. Method of measurement: Estimation base on formula.</prim_outcome>
      <prim_outcome>Insulin. Timepoint: before and 2 months after the intervention. Method of measurement: ELISA Kit.</prim_outcome>
      <prim_outcome>HbA1c. Timepoint: before and 2 months after the intervention. Method of measurement: Spectrophotometry.</prim_outcome>
      <prim_outcome>Malon Dialdehyde. Timepoint: before and 2 months after the intervention. Method of measurement: Spectrophotometry.</prim_outcome>
      <prim_outcome>Nitric Oxide. Timepoint: before and 2 months after the intervention. Method of measurement: Spectrophotometry.</prim_outcome>
      <prim_outcome>Total Antioxidan Capacity. Timepoint: before and 2 months after the intervention. Method of measurement: kit.</prim_outcome>
      <prim_outcome>Catalase. Timepoint: before and 2 months after the intervention. Method of measurement: kit.</prim_outcome>
      <prim_outcome>Super Oxide Dismutase. Timepoint: before and 2 months after the intervention. Method of measurement: kit.</prim_outcome>
      <prim_outcome>Glutathion Peroxidase. Timepoint: before and 2 months after the intervention. Method of measurement: kit.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: before and 2 months after the intervention. Method of measurement: Enzymatic method.</prim_outcome>
      <prim_outcome>HDL-Colesterol. Timepoint: before and 2 months after the intervention. Method of measurement: Enzymatic method.</prim_outcome>
      <prim_outcome>Total Cholesterol. Timepoint: before and 2 months after the intervention. Method of measurement: Enzymatic method.</prim_outcome>
      <prim_outcome>LDL-Cholesterol. Timepoint: before and 2 months after the intervention. Method of measurement: Estimation base on formula.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight. Timepoint: before, 1 month and 2 months after the intervention. Method of measurement: Scale.</sec_outcome>
      <sec_outcome>Energy and Macro-nutrient intake. Timepoint: before, 1 month and 2 months after the intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Body Mass Index. Timepoint: before, 1 month and 2 months after the intervention. Method of measurement: Estimation.</sec_outcome>
      <sec_outcome>Waist Circumference. Timepoint: before, 1 month and 2 months after the intervention. Method of measurement: mounted tape.</sec_outcome>
      <sec_outcome>Hip Circumferences. Timepoint: before, 1 month and 2 months after the intervention. Method of measurement: mounted tape.</sec_outcome>
      <sec_outcome>Waist to Hip Ratio. Timepoint: before, 1 month and 2 months after the intervention. Method of measurement: Estimation.</sec_outcome>
      <sec_outcome>Systolic Blood Pressure. Timepoint: before, 1 month and 2 months after the intervention. Method of measurement: digital system.</sec_outcome>
      <sec_outcome>Diastolic Blood Pressure. Timepoint: before, 1 month and 2 months after the intervention. Method of measurement: digital system.</sec_outcome>
      <sec_outcome>Physical activity level. Timepoint: before, 1 month and 2 months after the intervention. Method of measurement: Questionnaire.</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>Nutritional Research Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-04</approval_date>
        <contact_name>کمیته اخلاق دانشگاه علوم پزشکی تبریز</contact_name>
        <contact_address>Attar Neishaburi Ave, Golgasht Ave, Tabriz University of Medical Sciences تبریز East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
