<?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>IRCT20121021011192N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-06</date_registration>
      <primary_sponsor>Deputy of Research, Shahid Beheshti Universty of Medical Sciences</primary_sponsor>
      <public_title>Melatonin in type 2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of oral melatonin administration with placebo on biochemical parameters associated with diabetes in diabetes mellitus Type 2 patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27814</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: ُُSimple individual randomization with Microsoft Excel software, Blinding description: Participants, principle investigator, healthcare providers (Physicians, nurses) who care for participants during the trial, data collectors and outcome assessors all are blinded by providing placebo melatonin in same size, shape color, odor and package with real melatonin tablet which organized just by one responsible co-researcher has no involvement in running study.</study_design>
      <phase>3</phase>
      <hc_freetext>diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Addition of melatonin tablet orally 6 mg/d to  for 2 weeks Type 2 diabetes regimen for 2 months. Intervention 2: Control group: Addition of melatonin placebo tablet orally 6 mg/d to  for 2 weeks Type 2 diabetes regimen 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>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 There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nima Naderi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Pharmacy, Nyayesh  junction, Valiasr street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>00982188873704</zip>
        <telephone>+98 21 8820 9625</telephone>
        <email>naderi@sbmu.ac.ir</email>
        <affiliation>Deputy of research, School of Pharmacy, Shahid Beheshty Universiti of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad  Abbasinazari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Pharmacy, Nyayesh junction, Valiasr street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996835113</zip>
        <telephone>+98 21 8887 3704</telephone>
        <email>m_abbasi@sbmu.ac.ir</email>
        <affiliation>School of pharmacy, Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Type 2 diabetes based on ADA (American Diabetes Association) 2017 guideline
Age more than 18 years old</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of confirmed hypersensitivity reaction to melatonin or any parts of formulation
eGFR less than 30 ml/min/1.73m2
Liver failure (child pugh B, C)
Pregnancy &amp; lactation
Uncontrolled seizure &amp; untreated major depressive disorder
Concurrent use of fluvoxamine &amp; nifedipine</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus without complications</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Addition of melatonin tablet orally 6 mg/d to  for 2 weeks Type 2 diabetes regimen for 2 months</i_keyword>
      <i_keyword>Control group: Addition of melatonin placebo tablet orally 6 mg/d to  for 2 weeks Type 2 diabetes regimen for 2 months</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Change in hemoglobin A1C serum level. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.</prim_outcome>
      <prim_outcome>Change in fasting blood suger level. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.</prim_outcome>
      <prim_outcome>Change in percent of HOMA_IR. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.</prim_outcome>
      <prim_outcome>Change in percent of HOMA_Beta. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.</prim_outcome>
      <prim_outcome>Change in melatonin serum level. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.</prim_outcome>
      <prim_outcome>Change in total cholesterol serum level. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.</prim_outcome>
      <prim_outcome>Change in total L.D.L cholesterol serum level. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.</prim_outcome>
      <prim_outcome>Change in total H.D.L cholesterol serum level. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.</prim_outcome>
      <prim_outcome>Change in total triglyceride serum level. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.</prim_outcome>
      <prim_outcome>Change in total high sensitivity CRP serum level. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Record of Adverse drug reactions. Timepoint: During intervention. Method of measurement: Interview with patients.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Deputy of Research, Research Institute for Endocrine Sciences Shahid Beheshti University of Medical</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Deputy of Research, Shahid Beheshti Universty of Medical Sciences</source_name>
      <source_name>Deputy of Research, Research Institute for Endocrine Sciences Shahid Beheshti University of Medical</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-15</approval_date>
        <contact_name>Ethics committee of Research Institute for Endocrine Sciences  Shahid Beheshti University of Medical</contact_name>
        <contact_address>No.24 Arabi str., Daneshju Blvd., Yemen str., Velenjak Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
