<?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>IRCT20090117001556N153</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-22</date_registration>
      <primary_sponsor>Department of Health, Rescue and Treatment of I.R.Iran Police Force, Applied Research Center</primary_sponsor>
      <public_title>The effect of Melatonin for sleep and function of shift workers</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Melatonin on Sleep Quality and Cognitive Function of Shift Workers with Sleep Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71410</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization using A and B blocks in a 1:1 ratio will be done with n=4:
AABB, ABAB, ABBA, BABA, BAAB, BBAA
The blocks were randomly used  to achieve total sample size.
("A" and "B" are the study groups), Blinding description: An independent group will perform randomization, allocation concealment, and blinding procedures. The allocated group numbers will be kept confidential in sequentially numbered, sealed, and opaque envelopes to conceal treatment assignments from patients, healthcare providers, outcome assessors, and the research team. Melatonin and matched placebo are identical in size, shape, color, smell, and taste.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Sleep disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Melatonin (C13H16N2O2) in the form of tablets with a dose of 5 mg produced by Jalinous Pharmaceutical Company, administered orally 30 minutes before the person's desired time to sleep at night after shift work for one month. Intervention 2: Control group: Placebo in tablet form, completely similar to the medication in terms of shape, color, smell and taste produced by Jalinous Pharmaceutical Company.</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 The decision maker is the research center.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sajad Khanjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417944661</zip>
        <telephone>+98 21 8123 5481</telephone>
        <email>khanjanis23@yahoo.com</email>
        <affiliation>Department of Health, Rescue and Treatment of I.R.Iran Police Force, Applied Research Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahin Akhondzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>South Kargar St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1333715914</zip>
        <telephone>+98 21 5541 2222</telephone>
        <email>s.akhond@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being a resident physician with night shift work
Age between 25 and 55 years
Working at least seven night shifts in the past month
Having an schedule to work at least seven night shifts during the study month
Complaining about sleep disturbance after shift work and poor sleep quality (Cut-off value greater than 4 in shortPSQI)</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Complaining about sleep disturbance during normal sleeping hours (always and not related to the night shift)
Pregnancy, breastfeeding or intention to become pregnant in female participants
History of sensitivity or side effects after taking melatonin and its agonists
History of thyroid, cardiovascular, kidney, and endocrine diseases and psychiatric disorders (except sleep disorder)
Working less than six night shifts during the study month</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F51</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sleep disorders not due to a substance or known physiological condition</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: Melatonin (C13H16N2O2) in the form of tablets with a dose of 5 mg produced by Jalinous Pharmaceutical Company, administered orally 30 minutes before the person's desired time to sleep at night after shift work for one month</i_keyword>
      <i_keyword>Control group: Placebo in tablet form, completely similar to the medication in terms of shape, color, smell and taste produced by Jalinous Pharmaceutical Company</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep Quality. Timepoint: Baseline, Week 1, and Week 4. Method of measurement: Short Pittsburgh Sleep Quality Index.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Occupational Cognitive Failure. Timepoint: Baseline, Week 1, and Week 4. Method of measurement: Occupational Cognitive Failure Questionnaire.</sec_outcome>
      <sec_outcome>Side effects. Timepoint: Baseline, Week 1, Week 4, and whenever the participant experiences a complication, by phone. Method of measurement: Checklist of side effects in which the side effects of melatonin are clearly reported, and it is possible for the participant to report other side effects that are not included in it.</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>Department of Health, Rescue and Treatment of I.R.Iran Police Force, Applied Research Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-06</approval_date>
        <contact_name>Research Ethics Committees of Directorate of Health, Rescue and Treatment of Police Headquarter of I</contact_name>
        <contact_address>Valiasr St Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
