<?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>IRCT20170701034828N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-12-28</date_registration>
      <primary_sponsor>Vice chancellor for research, Shahed University</primary_sponsor>
      <public_title>Effect of dietary interventions based on Persian medicine on infantile gastroesophageal reflux.</public_title>
      <acronym></acronym>
      <scientific_title>Effect of appliance of dietary interventions based on Persian medicine by nursing mothers on infantile gastroesophageal reflux.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26509</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method is permuted block randomization. Each unit of randomization is a person, Blinding description: This is a single binde trial, which participents are not aware of the two intervention methods.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Infantile Gastroesophageal Reflux.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1 (Intervention Group) : Dietary interventions based on Persian medicine will be presented to nursing mothers of this group in 1 session (1st clinical visit) as face to face teaching by executor of plan, and the written guidance paper will be. Intervention 2: Intervention 2 (Control Group): Classic medicine’s standard treatment strategy of mild to moderate infantile GERD which is about lifestyle modifications and breastfeeding pattern, will be presented to control group. So these infants are not being deprived.</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></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Jahangir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahed University, Front of Imam Khomeini holy shrine, Persian Gulf freeway (Tehran-Qom), Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3319118651</zip>
        <telephone>+98 21 5121 4055</telephone>
        <email>m.jahangir@shahed.ac.ir</email>
        <affiliation>Department of Persian Medicine, School of Medicine, Shahed University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Elham Emaratkar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahed University, Front of Imam Khomeini holy shrine, Persian Gulf freeway (Tehran-Qom), Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3319118651</zip>
        <telephone>+98 21 5121 4055</telephone>
        <email>e.emaratkar@gmail.com</email>
        <affiliation>Department of Persian Medicine, School of Medicine, Shahed University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Infants under 5 months old (girls and boys)
Exclusive breastfeeding
Clinically confirmation of infantile GER by the pediatric gastroenterologist
Score of Gastroesophageal Reflux Questionnair - Infantile (GSQ-I questionnaire) above 16 (the min score for confirm GER)</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>5 months</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any diagnosed disease of mother or infant that needs medical or surgical therapy
Any other type of gastrointestinal disease such as hiatal hernia, erosive esophagitis, etc in infants
Necessity of medical treatment for infantile reflux at the bigining or through the study
Any diagnosed disease of mother or infant that due to it breastfeeding is forbidden
Any consumption of effective medicine on GER in infants, such as Proton pump inhibitors, H2-receptor antagonists, etc</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P78.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified perinatal digestive system disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention 1 (Intervention Group) : Dietary interventions based on Persian medicine will be presented to nursing mothers of this group in 1 session (1st clinical visit) as face to face teaching by executor of plan, and the written guidance paper will be</i_keyword>
      <i_keyword>Intervention 2 (Control Group): Classic medicine’s standard treatment strategy of mild to moderate infantile GERD which is about lifestyle modifications and breastfeeding pattern, will be presented to control group. So these infants are not being deprived</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Frequency of Infantile Gastroesophageal Reflux signs. Timepoint: Before intervention, 2 weeks after intervention, the end of intervention (4th week), 6th week. Method of measurement: GERD Symptoms Questionnaire for infants (GSQ-I).</prim_outcome>
      <prim_outcome>Severity of Infantile Gastroesophageal Reflux signs. Timepoint: Before intervention, 2 weeks after intervention, the end of intervention (4th week), 6th week. Method of measurement: GERD Symptoms Questionnaire for infants (GSQ-I).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Infant weight. Timepoint: Before intervention, The end of intervention (4th week). Method of measurement: Baby scale, Gramme.</sec_outcome>
      <sec_outcome>Infant height. Timepoint: Before intervention, The end of intervention (4th week). Method of measurement: Measuring board, centimeter.</sec_outcome>
      <sec_outcome>Nursing mothers' gastric temperament. Timepoint: Before intervention, The end of intervention (4th week). Method of measurement: Gastric temperament check list.</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>Vice chancellor for research, Shahed University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-27</approval_date>
        <contact_name>Shahed University, Ethics Committee on Biomedical Research</contact_name>
        <contact_address>Shahed University, Front of Imam Khomeini holy shrine, Persian Gulf freeway (Tehran-Qom), Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
