<?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>IRCT20170423033605N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-17</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>The effect of coconut oil on  enuresis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of coconut oil on mono symptomatic primary enuresis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25877</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Through the delivery of envelopes in which they are written as sample or control, Blinding description: The participants, the main researcher who is also a clinical caregiver and outcome evaluator, were blinded in this study.</study_design>
      <phase>1</phase>
      <hc_freetext>enuresis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Coconut oil: 6 drops of coconut oil are sacrificed in each of the supra pubic, perineal, sacral and flank areas, and each night before bed, these areas are anointment by the child's parents.          Control group: Placebo: In the above areas, a placebo is used to anointment. Intervention 2: Control group: Six placebo drops are sacrificed in each supra pubic, perineal, sacral and analgesic areas and each night before bed, these areas are anointment by the child's parents.</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 total potential data can be shared after unidentifiable people

When:
Start the access period 6 months after printing the results

To whom:
Only available to scholars working in academia

Conditions:
To promote the level of pediatric's health, especially psychologically
Use of data is conditional on obtaining permission from the original researcher.

Where to obtain:
Dr. Abolfazl Dehghanpour, Iranian Clinic of Medicine, Yazd-Ardakan- Imam Khomeini Ave., Faculty of Iranian Medicine, Postcode: 8951737915
Phone: 035-37238915-18
Email: tebsonati@ssu.ac.ir

How to obtain:
Six months after the article was published in one of the ISI journals, the applicant can submit his request by email (at A.dehghanpoor@ssu.ac.ir) and obtain permission to receive the data.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abolfazl Dehghanpoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Clinic of Persian medicine ; Imam Khomeini Street</address>
        <city>Ardekan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8951737915</zip>
        <telephone>+98 35 3723 8915</telephone>
        <email>A.Dehghanpoor@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Majid Emtiazy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Clinic of Persian Medicine ; Imam Khomeini Street</address>
        <city>Ardekan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8951737915</zip>
        <telephone>+98 35 3723 8915</telephone>
        <email>tebsonati@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children with enuresis 6 years and older
Do not take medication for  complaints two weeks before the start of the study
Gain consent to enter the study and continue it
Possibility of patient tracking</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>16 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>There are other symptoms of the lower urinary tract
Positive urine test for urinary tract infection during the study
Hematuria
Proteinuria
Glucosuria
Anatomical and congenital anomalies
The creation of a dangerous side effect due to drug use
Patient refusal to continue cooperation
Create an unpredictable problem for each patient</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F98.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Enuresis (primary)(secondary) of non organic origin</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: Coconut oil: 6 drops of coconut oil are sacrificed in each of the supra pubic, perineal, sacral and flank areas, and each night before bed, these areas are anointment by the child's parents.          Control group: Placebo: In the above areas, a placebo is used to anointment.</i_keyword>
      <i_keyword>Control group: Six placebo drops are sacrificed in each supra pubic, perineal, sacral and analgesic areas and each night before bed, these areas are anointment by the child's parents.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The frequency of nocturia per week. Timepoint: Before the intervention, 2 weeks, 4 weeks and 8 weeks after the intervention. Method of measurement: Questionnaire on the frequency of nocturia per week.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Age. Timepoint: Before intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Sex. Timepoint: Before intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Complications of intervention. Timepoint: 2 weeks, 4 weeks and 6 weeks after intervention. Method of measurement: questionnaire.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-12-26</approval_date>
        <contact_name>Ethics committee of Yazd Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>Yazd, Shahid Dr. Bahonar Square, Shahid Sadoughi Blvd, Central Office of Yazd Shahid Sadoughi University of Medical Sciences and Health Services Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
