<?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>IRCT20210125050135N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-09</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Comparison the effect of industrial and traditional honeys on blood glucose levels in diabetic patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison effects of industrial and traditional honeys on blood glucose levels and its correlation with sucrose tests of honey (randomized clinical trial)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53893</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Blinding description: Clinical caregivers and patients will not know whether they are in the control or intervention group. In this way, industrial, traditional honeys, fructose syrup and drinking water are prepared by a person (out-of-study,in a room away from the eyes of clinical caregivers and patients) in equal amounts in similar glasses as soluble and then coded, that only he is known from the contents of the dishes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetes Mellitus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Diabetic patients receiving traditional honey (equivalent to 50 grams of carbohydrates consumed in the diet, once, fasting). Intervention 2: Intervention group 2: Diabetic patients receiving industrial honey (produced in Khomeyn Honey's Ferdows factory, with thr Giti Sabz Khomeyn brand), (equivalent to 50 grams of carbohydrates consumed in the diet, once, fasting). Intervention 3: Intervention group 3: Diabetic patients receiving industrial honey (produced in Khomeyn Honey's Salar factory, with the Salar brand), (equivalent to 50 grams of carbohydrates consumed in the diet, once, fasting). Intervention 4: Intervention group 4: Diabetic patients receiving industrial honey (produced in Shahram Nabavi's factory, with the Teymareh brand), (equivalent to 50 grams of carbohydrates consumed in the diet, once, fasting). Intervention 5: Intervention group 5: Diabetic patients receiving fructose syrup (produced in Zar Industrial and Research Group, with the Zar brand) (equivalent to 50 grams of carbohydrates consumed in the diet, once, fasting). Intervention 6: Control group: Patients receiving drinking water (130 cc, once, fasting).</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The information will be published in the final report and article.

When:
The information will be published in the final report and article.

To whom:
The information will be published in the final report and article.

Conditions:
The information will be published in the final report and article.

Where to obtain:
The information will be published in the final report and article.

How to obtain:
The information will be published in the final report and article. If they need more information, they can send an email to responsible author.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abbas Alimoradian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak, Golestan District - Deputy of Food and Drug Arak University of Medical Sciences</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3818653366</zip>
        <telephone>+98 86 3367 8626</telephone>
        <email>ab_alimoradian@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abbas Alimoradian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak, Golestan District - Deputy of Food and Drug</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3818653366</zip>
        <telephone>+98 86 3368 5570</telephone>
        <email>ab_alimoradian@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Fast blood sugar upper 110 mg/dl</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnant and breastfeeding women
Patients with history of major surgery,  or underlying disease, including cardiovascular and infectious
Non-insulin dependent diabetes mellitus</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E08</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Diabetic patients receiving traditional honey (equivalent to 50 grams of carbohydrates consumed in the diet, once, fasting)</i_keyword>
      <i_keyword>Intervention group 2: Diabetic patients receiving industrial honey (produced in Khomeyn Honey's Ferdows factory, with thr Giti Sabz Khomeyn brand), (equivalent to 50 grams of carbohydrates consumed in the diet, once, fasting)</i_keyword>
      <i_keyword>Intervention group 3: Diabetic patients receiving industrial honey (produced in Khomeyn Honey's Salar factory, with the Salar brand), (equivalent to 50 grams of carbohydrates consumed in the diet, once, fasting)</i_keyword>
      <i_keyword>Intervention group 4: Diabetic patients receiving industrial honey (produced in Shahram Nabavi's factory, with the Teymareh brand), (equivalent to 50 grams of carbohydrates consumed in the diet, once, fasting)</i_keyword>
      <i_keyword>Intervention group 5: Diabetic patients receiving fructose syrup (produced in Zar Industrial and Research Group, with the Zar brand) (equivalent to 50 grams of carbohydrates consumed in the diet, once, fasting)</i_keyword>
      <i_keyword>Control group: Patients receiving drinking water (130 cc, once, fasting)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fast Blood Sugar (FBS). Timepoint: FBS is measured at the beginning of study, then 30 minutes after consumption of honey will be measured again. Method of measurement: Digital blood glucose testing device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-19</approval_date>
        <contact_name>Arak University of Medical Sciences</contact_name>
        <contact_address>A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
