<?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>IRCT20190303042905N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-17</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The effects of melatonin supplementation on type 2 diabetes mellitus</public_title>
      <acronym></acronym>
      <scientific_title>The effects of melatonin supplementation on mean arterial pressure, pulse pressure, atherogenic index of plasma and new anthropometric index in type 2 diabetes mellitus patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38114</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Based on inclusion criteria, 50 patients will be randomly allocated to placebo (n = 25) or intervention (n = 25) groups. Block design based on the combined analysis will be used for randomization. In fact, according to pattern and using two codes of A and B 6 groups with 4 blocks will be select. This work is repeated in 2 steps. At the end, two A and B codes will be assign to the 2 last people and the randomization will be complete (50 patients), Blinding description: Patients with type 2 diabetes who go to the diabetes Clinic of Department of Golestan Hospital are selected. Participants in this study and person who responsible for data collection are not aware of the type of drug used. َAlso, the researchers and patients  are not aware of the contents of the packets (a double-blind). The coding in this study will be done by a person outside the study who has information about diabetes and knows what code is related to supplement and which is related to placebo. But do not have much information about the details of our research methods.</study_design>
      <phase>2</phase>
      <hc_freetext>type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:intervention group  receive two melatonin tablets(Nature Made, USA) (3 mg) per day for 60 days. Intervention 2: Control group: The control group receive 2 tablets of placebo 3 mg per day containing cellulose, silicone dioxide and starch (made by the Faculty of Pharmacy, Ahvaz Jundishapur University of Medical Sciences) for 60 days.</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 Due to the financial support of this research by the Ahvaz Jundishapur University of Medical Sciences , data of the study will be published after the end of the intervention as an article.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parichehr Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Khuzestan, Ahvaz, Iran</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4445561358</zip>
        <telephone>+98 21 4568 9745</telephone>
        <email>amiriparichehr70@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ahmad Zare Javid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, khuzestan, Ahvaz, Iran</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1456978253</zip>
        <telephone>+98 74 3333 1475</telephone>
        <email>ahmaddjavid@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>age between 30-60
diagnosed diabetes more than 5 years</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to participate in the study
complications of diabetes mellitus such as kidney failure
insulin-dependent diabetic patients
pregnancy
lactation
travel for more than 2 weeks
smokers
use of food supplements
probiotics and anti-inflammatory drugs
Using any antioxidant supplements in the last 3 months
using immunosuppressive medications
following specific diets
change of diet or deciding to lose weight in the last 6 months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:intervention group  receive two melatonin tablets(Nature Made, USA) (3 mg) per day for 60 days</i_keyword>
      <i_keyword>Control group: The control group receive 2 tablets of placebo 3 mg per day containing cellulose, silicone dioxide and starch (made by the Faculty of Pharmacy, Ahvaz Jundishapur University of Medical Sciences) for 60 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Triglycerides. Timepoint: before and after intervention. Method of measurement: enzymatic assay by kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>High density lipoprotein. Timepoint: before and after intervention. Method of measurement: enzymatic assay by kit.</sec_outcome>
      <sec_outcome>Mean arterial pressure(MAP). Timepoint: before and after intervention. Method of measurement: MAP(mmHg)=[systolic blood Pressure +(2×diastolic blood pressure)]/3.</sec_outcome>
      <sec_outcome>Pulse pressure(PP). Timepoint: before and after intervention. Method of measurement: formula:PP(mmHg)= systolic blood pressure (mmHg)  - diastolic blood pressure(mmHg).</sec_outcome>
      <sec_outcome>Atherogenic index of plasma(AIP). Timepoint: before and after intervention. Method of measurement: based on formula: AIP=log⁡〖triglycerides /high density lipoprotein〗.</sec_outcome>
      <sec_outcome>Weight. Timepoint: before and after intervention. Method of measurement: with Seca scale, light clothes and precision of 0.1 kg.</sec_outcome>
      <sec_outcome>Waist circumference(WC). Timepoint: before and after intervention. Method of measurement: a non-stretchable measuring tape as the smallest horizontal girth between the costal and iliac crests at minimal respiration.</sec_outcome>
      <sec_outcome>A body shape index(ABSI). Timepoint: before and after intervention. Method of measurement: based on formula: ABSI=waist circumfrence/(〖Body mass index〗^(2/3) 〖×height〗^(1/2) ).</sec_outcome>
      <sec_outcome>Lipid Accumulation Product(LAP). Timepoint: before and after intervention. Method of measurement: based on formula.</sec_outcome>
      <sec_outcome>Abdominal volume index(AVI). Timepoint: before and after intervention. Method of measurement: based on formula.</sec_outcome>
      <sec_outcome>Body adiposity index(BAI). Timepoint: before and after intervention. Method of measurement: based on formula.</sec_outcome>
      <sec_outcome>Conicity. Timepoint: before and after intervention. Method of measurement: based on formula.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-02</approval_date>
        <contact_name>Ethics committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, khuzestan, Ahvaz, Iran Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
