<?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>IRCT20150803023478N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-02</date_registration>
      <primary_sponsor>Psychiatry and psychology research center</primary_sponsor>
      <public_title>Effects of emoution regulation, acupuncture.TACS with retalin on attention deficit disorder / hyperactivity</public_title>
      <acronym></acronym>
      <scientific_title>Compare of Effects of emoution regulation,acupuncture.TACS with retalin on attention deficit disorder / hyperactivity</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>4</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27922</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: simple : 120 children aged 12-8 years with ADHD were randomly selected from patients referred to the psychiatric clinic of children and adolescents after the diagnosis of psychiatry in children and adolescents. This people have been randomly assigned to draw lots in four groups with code. children will be randomly assigned to acupuncture, TACS, drugs, and excitement training.</study_design>
      <phase>2</phase>
      <hc_freetext>attention deficit disorder / hyperactivity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: pharmacological intervention (for 8 weeks) treatment protocol Ritalin: children under 30 kg the first week of morning, 1/4 tablet, noon 1/4 tablets, the second week until the eighth morning, 1/2 tablet, noon 1/2 tablets, 30 kg of the first week of morning, 1/4 tablet noon 1/4 tablets, the second week of the third morning, 1/2 tablet, noon 1/2 tablets, week, quarter to eight in the morning a tablet, noon a tablet. Intervention 2: Intervention group: interventional therapy ear acupuncture (8 weeks, every day two times, each time for each point a Minutes Medium equitability on glue ear (ear seed) on a five-point on auricle, Brain, Excitement, Prefrontal Cortex, Shen Men, and Tranquilizar given. Intervention 3: Intervention group: 30 were under treatment intervention with TACS (8 weeks and weeks three days ) in the treatment of alternating current to the anode and cathode supplant. Gets colon on the anode F3 (dorsolateral frontal left) pad small cathode (dorsolateral frontal right-F4 mini pad to lack of anodes C3 iPad mini cathode C4 mini pad to hyperactivity Impulsivity use It will be. 1-Stream is set to 1 mA. 2-Rise-Fall is set to 30 seconds. 3- Frequency is set to 10 Hz for lack of attention and 13 Hz for hyperactivity-impulsivity for 10-15 minutes. Intervention 4: Intervention group: Therapeutic Therapy Training Course included: 8 sessions and each session was trained for one and half hours.</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 Because of the ethical issues, individual data is not identifiable.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farideh farrokhzadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Enghelab Square - South Kargar Avenue</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1333795914</zip>
        <telephone>+98 21 5542 1959</telephone>
        <email>Farokhzadi.f@gmail.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammadreza Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Enghelab Square.South Kargar Avenue</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1333795914</zip>
        <telephone>+98 21 5541 3540</telephone>
        <email>Mohammadimr@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>children aged 12-8 years with ADHD-
IQ&gt;90</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>autism spectrum disorder
IQ&lt;90</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F90.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Attention-deficit hyperactivity disorder, combined type</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: pharmacological intervention (for 8 weeks) treatment protocol Ritalin: children under 30 kg the first week of morning, 1/4 tablet, noon 1/4 tablets, the second week until the eighth morning, 1/2 tablet, noon 1/2 tablets, 30 kg of the first week of morning, 1/4 tablet noon 1/4 tablets, the second week of the third morning, 1/2 tablet, noon 1/2 tablets, week, quarter to eight in the morning a tablet, noon a tablet</i_keyword>
      <i_keyword>Intervention group: interventional therapy ear acupuncture (8 weeks, every day two times, each time for each point a Minutes Medium equitability on glue ear (ear seed) on a five-point on auricle, Brain, Excitement, Prefrontal Cortex, Shen Men, and Tranquilizar given</i_keyword>
      <i_keyword>Intervention group: 30 were under treatment intervention with TACS (8 weeks and weeks three days ) in the treatment of alternating current to the anode and cathode supplant. Gets colon on the anode F3 (dorsolateral frontal left) pad small cathode (dorsolateral frontal right-F4 mini pad to lack of anodes C3 iPad mini cathode C4 mini pad to hyperactivity Impulsivity use It will be. 1-Stream is set to 1 mA. 2-Rise-Fall is set to 30 seconds. 3- Frequency is set to 10 Hz for lack of attention and 13 Hz for hyperactivity-impulsivity for 10-15 minutes</i_keyword>
      <i_keyword>Intervention group: Therapeutic Therapy Training Course included: 8 sessions and each session was trained for one and half hours</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Attention, their impulsivity, and their active involvement. Timepoint: Before and after intervention. Method of measurement: questionnaire CSI (parent's form) CSI-4 test IVA.</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>Psychiatry and psychology research center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-11-26</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Enghelab Square,south kargar Avenue,Roozbeh Hospital, psychiatry Research center Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
