<?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>IRCT2017102418858N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-11-13</date_registration>
      <primary_sponsor>University of Medical Sciences and Health Services, Yazd</primary_sponsor>
      <public_title>The effect of natural sweetener lacrithosis on blood glucose in type 2 diabetic patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of average blood sugar in people with type II diabetes natural sweetener consumers Lacriroze and control group-clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-11-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16994</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2</phase>
      <hc_freetext>Non-insulin-dependent diabetes mellitus.</hc_freetext>
      <i_freetext>Intervention 1: Sucrose and Lacritoze. Intervention 2: Lacritoze. Intervention 3: Sucrose.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mozhghan Modarresi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran, Yazd, Diabete Research Center</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 35 3728 0226</telephone>
        <email>mdmodarresi@gmail.com</email>
        <affiliation>Yazd University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Nazemian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Talar honar alley, Bahonar square, Yazd, Iran</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 35 3728 0226</telephone>
        <email>reza46ny@yahoo.com</email>
        <affiliation>Yazd University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Type 2 diabetes, the age group of 30-60, fasting blood glucose less than 200 mg / dl, HbA1C≤9≥7, are under the control of oral hypoglycemic or dietary medications, are not treated with insulin. Sugar in the diet of the patient. Drugs for blood sugar, blood lipids and blood pressure did not change during the past month, having a medical record at the Yazd diabetes research center, a willingness to participate in research.&#13;
Exclusion criteria: Patient's inability to follow-up (life in the city, end stage, patients who need to control high blood sugar due to complications of diabetes, those who have a severe change in their calories and their activity, people with deficiency of Lactose, pregnancy And lactation, patients with severe infections or endocrine disorders, those with acute illnesses, people with liver and kidney failure, patients with diabetes complications (nephropathy, neuropathy, retinopathy), BMI≥35</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Sucrose and Lacritoze</i_keyword>
      <i_keyword>Lacritoze</i_keyword>
      <i_keyword>Sucrose</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>FBS. Timepoint: Before the intervention, After the intervention. Method of measurement: Blood Test.</prim_outcome>
      <prim_outcome>2hPP. Timepoint: Before the intervention, After the intervention. Method of measurement: Blood Test.</prim_outcome>
      <prim_outcome>Fructosamine. Timepoint: Before the intervention, After the intervention. Method of measurement: Blood Test.</prim_outcome>
      <prim_outcome>Insulin. Timepoint: Before the intervention, After the intervention. Method of measurement: Blood Test.</prim_outcome>
      <prim_outcome>Urea. Timepoint: Before the intervention, After the intervention. Method of measurement: Blood Test.</prim_outcome>
      <prim_outcome>Cr. Timepoint: Before the intervention, After the intervention. Method of measurement: Blood Test.</prim_outcome>
      <prim_outcome>SGOT. Timepoint: Before the intervention, After the intervention. Method of measurement: Blood Test.</prim_outcome>
      <prim_outcome>SGPT. Timepoint: Before the intervention, After the intervention. Method of measurement: Blood Test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>BMI. Timepoint: Before the intervention, After the intervention. Method of measurement: Balance and meter.</sec_outcome>
      <sec_outcome>Digestive complications. Timepoint: Before the intervention, After the intervention. Method of measurement: Questionare.</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>University of Medical Sciences and Health Services, Yazd</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-15</approval_date>
        <contact_name>Ethics committee of Yazd University of Medical Science</contact_name>
        <contact_address>Bahonar square, Yazd, Iran Yazd  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
