<?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>IRCT20191216045752N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-28</date_registration>
      <primary_sponsor>Research Institute for Islamic and Complementary Medicine</primary_sponsor>
      <public_title>Comparative study of the effect of abdominal massage with rose oil and olive oil on the symptoms of Gastroesophagal reflux disease in pediatrics</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of the effect of abdominal massage with rose oil and olive oil on the symptoms of Gastroesophagal reflux disease in pediatrics</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44437</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The presenter divides the participants into two groups according to the severity of the disease and refers them to the secretary of the ward.Two series of randomized blocks for severely and moderately ill patients are already provided to the secretary, in which letters A and B are written in unspecified sequences.Depending on the severity of the disease, the secretary selects one of these groups for the patient and gives him/her the appropriate drug.The drugs, which are almost similar in color and smell, are packed in 60cc containers and given to the secretary who is unaware of the contents of the container, Blinding description: The presenter divides the participants into two groups according to the severity of the disease and refers them to the secretary of the ward.Two series of randomized blocks for severely and moderately ill patients are already provided to the secretary, in which letters A and B are written in unspecified sequences.Depending on the severity of the disease, the secretary selects one of these groups for the patient and gives him/her the appropriate drug.The drugs, which are almost similar in color and smell, are packed in 60cc containers and given to the secretary who is unaware of the contents of the container.</study_design>
      <phase>3</phase>
      <hc_freetext>gastroesophageal reflux (GERD).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Infants from 2 months to 1 year of age with gastroesophageal reflux of the first group, in addition to the usual treatment, are given an abdominal massage with rose oil  (in the base of olive oil) every 12 hours. For greater effectiveness, a topical abdominal massaging method is chosen, with 1-5 drops per 10-15 minutes based on birth months. Intervention 2: Intervention group: Infants from 2 months to 1 year of age with gastroesophageal reflux of the second group, in addition to the usual treatment, are given an abdominal massage with olive oil every 12 hours. For greater effectiveness, a topical abdominal massaging method is chosen, with 1-5 drops per 10-15 minutes based on birth months.</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:
This will be mentioned in the article method.

When:
This will be mentioned in the article method.

To whom:
This will be mentioned in the article method.

Conditions:
This will be mentioned in the article method.

Where to obtain:
This will be mentioned in the article method.

How to obtain:
This will be mentioned in the article method.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hoorieh mohammadi Kenari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.748, Behesht street, Vahdat eslami Ave., Hasan Abad Sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>114733311</zip>
        <telephone>+98 21 5558 0388</telephone>
        <email>mohammadikenari.h@iums.ac.ir</email>
        <affiliation>Research Institute for Islamic and Complementary Medicine</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hoorieh mohammadi Kenari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.748, Behesht street, Vahdat eslami Ave., Hasan Abad Sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>114733311</zip>
        <telephone>+98 21 5558 0388</telephone>
        <email>mohammadikenari.h@iums.ac.ir</email>
        <affiliation>Research Institute for Islamic and Complementary Medicine</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children 2 months to 1 year referred to Ali Asghar Hospital Clinic
Diagnosis of GERD based on GSQ-I questionnaire by  pediatric gastroenterologist</inclusion_criteria>
      <agemin>2 months</agemin>
      <agemax>1 year</agemax>
      <gender>Both</gender>
      <exclusion_criteria>serious gastrointestinal diseases such as esophagitis, achalasia, gastrointestinal ulcers, inflammatory gastrointestinal diseases
A history of allergy to herbal ingredients
Allergy to cow milk protein
History of gastrointestinal surgery
History of liver, kidney, neurologic or severe cardiopulmonary diseases
Inability of parents to cooperate in filling out  the forms (mental disorders or language problems)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Infants from 2 months to 1 year of age with gastroesophageal reflux of the first group, in addition to the usual treatment, are given an abdominal massage with rose oil  (in the base of olive oil) every 12 hours. For greater effectiveness, a topical abdominal massaging method is chosen, with 1-5 drops per 10-15 minutes based on birth months.</i_keyword>
      <i_keyword>Intervention group: Infants from 2 months to 1 year of age with gastroesophageal reflux of the second group, in addition to the usual treatment, are given an abdominal massage with olive oil every 12 hours. For greater effectiveness, a topical abdominal massaging method is chosen, with 1-5 drops per 10-15 minutes based on birth months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The intensity and frequency of vomiting during the past 7 days. Timepoint: Weeks 1, 2, 3 and 4 during the intervention and weeks 1 and 4 after the intervention. Method of measurement: Asking parents.</prim_outcome>
      <prim_outcome>Time to control symptoms. Timepoint: Weeks 1, 2, 3 and 4 during the intervention and weeks 1 and 4 after the intervention. Method of measurement: Asking parents.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Crying and restlessness while breastfeeding. Timepoint: Weeks 1, 2, 3 and 4 during the intervention and weeks 1 and 4 after the intervention. Method of measurement: Asking parents.</sec_outcome>
      <sec_outcome>Side effects. Timepoint: Weeks 1, 2, 3 and 4 during the intervention and weeks 1 and 4 after the intervention. Method of measurement: Asking parents.</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>Research Institute for Islamic and Complementary Medicine</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-04</approval_date>
        <contact_name>Iran university of medical sciences</contact_name>
        <contact_address>Hemat highway, next to Milad tower tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
