<?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>IRCT20120913010826N19</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-04</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>The effect of saffron tablet in obese prediabetic patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of saffron tablet on lipid profiles and blood glucose and oxidative stress in obese prediabetic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11258</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Block randomization will be done using www.randomization.com to assign equal participants in each group (1:1 allocation ). An independent researcher will make random allocation cards using computer-generated random numbers. he will keep the original random allocation sequences until analysis time. Another independent researcher will measure the patients outcome and she will not know the allocation, Blinding description: dietary supplements and placebo produced and coded in similar shape, color, and size by the company. Allocation concealment will be done using sealed envelopes. So, principal researcher, clinician, and participants are not aware about group assignment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Obese Pre-dabetic.</hc_freetext>
      <i_freetext>Intervention 1: The control group will receive placebo (the same as  saffron pill in doses of 15mg)once a day for 8 weeks. Intervention 2: The intervention group will receive saffron pill in dosage 15 mg ,once a 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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Decisions will be made case by case based on requests.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Azadeh Nadjarzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>department of nutrition, school of public health,shahid sadoughi university of medical sciences, Yazd, Iran</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173160</zip>
        <telephone>+98 35 3149 2239</telephone>
        <email>azadnajarzadeh@ssu.ac.ir</email>
        <affiliation>shahid sadoughi university of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Azadeh Nadjarzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>department of nutrition, school of public health,shahid sadoughi university of medical sciences, Yazd, Iran</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173160</zip>
        <telephone>+98 35 3149 2239</telephone>
        <email>azadnajarzadeh@ssu.ac.ir</email>
        <affiliation>shahid sadoughi university of medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>all patients which are defined as pre-diabetes who referring to the Imam Ali nutrition clinic
all patients with BMI greater than 25 who referring to the Imam Ali nutrition clinic</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
change in diet or physical activity
change in dosage
change in  type of drug
Lack of interest in cooperation
having other diseases in during the study
Do not use more than 30% pills</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R73.02</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Impaired glucose tolerance (oral)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The control group will receive placebo (the same as  saffron pill in doses of 15mg)once a day for 8 weeks</i_keyword>
      <i_keyword>The intervention group will receive saffron pill in dosage 15 mg ,once a day (for 8 weeks)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>LDL (lipid profile index). Timepoint: Before and after intervention. Method of measurement: Standards of medical diagnostic laboratories.</prim_outcome>
      <prim_outcome>TG (lipid profile index). Timepoint: Before and after intervention. Method of measurement: Standards of medical diagnostic laboratories.</prim_outcome>
      <prim_outcome>Cholesterol(lipid profile index). Timepoint: Before and after intervention. Method of measurement: Standards of medical diagnostic laboratories.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Triglyceride, , LDL-Chol, BUN, Creatinine, DPPH. Timepoint: before and after intervention. Method of measurement: Standards of medical diagnostic laboratories.</sec_outcome>
      <sec_outcome>Cholesterol. Timepoint: before and after intervention. Method of measurement: Standards of medical diagnostic laboratories.</sec_outcome>
      <sec_outcome>LDL cholesterol concentration. Timepoint: before and after intervention. Method of measurement: Standards of medical diagnostic laboratories.</sec_outcome>
      <sec_outcome>BUN. Timepoint: before and after intervention. Method of measurement: Standards of medical diagnostic laboratories.</sec_outcome>
      <sec_outcome>Creatinine. Timepoint: before and after intervention. Method of measurement: Standards of medical diagnostic laboratories.</sec_outcome>
      <sec_outcome>DPPH. Timepoint: before and after intervention. Method of measurement: Standards of medical diagnostic laboratories.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-03-05</approval_date>
        <contact_name>Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>Campus of Sadoughi University of Medical Sciences, Shohadaye Gomnam Blv,Yazd Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
