<?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>IRCT201009094722N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-04-26</date_registration>
      <primary_sponsor>Golestan University Of Medical Sciences, Gorgan, Iran</primary_sponsor>
      <public_title>The effect of Ginger extract on gastric residual volume in patients with mechanical ventilation hospitalized in intensive care unit</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Ginger extract on gastric residual volume in patients with mechanical ventilation hospitalized in intensive care unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>26</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5043</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Ischaemic heart diseases. Condition 2: Cerebrovascular  diseases. Condition 3: Chronic lower respiratory diseases. Condition 4: Hypertensive diseases. Condition 5: Diseases of the nervous system. Condition 6: Diseases of the circulatory system.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 3ml ginger extract plus 40ml water through NGT, twice a day, will be added to the special food for the feeding via NG tube. Intervention 2: Control group: 43 ml water, twice a day, as placebo, will be added to the special food for the feeding via NG tube.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mitra Hekmatafshar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan University of Medical Sciences, Bouyeh School of Nursing and  midwifery, Shastkola Road, Gorgan</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 17 1443 0360</telephone>
        <email>hekmatafshar@goums.ac.irm.hekmatafshar@yahoo.comm.hekmatafshar@gmail.com</email>
        <affiliation>Golestan University Of Medical Sciences, Gorgan, Iran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Mahasti Jouybari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan University of Medical Sciences, Bouyeh School of Nursing and midwifery, Shastkola Road, Gorgan</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 17 1443 0360</telephone>
        <email>jouybari@gmail.com</email>
        <affiliation>Golestan University Of Medical Sciences, Gorgan, Iran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: mechanical ventilation for less than 48 hrs, patients with nasogastric tube feeding (NGT), age 18-60 years old, presence of medical or surgical problems hospitalized in intensive care unit&#13;
Exclusion criteria: Presence of gallstone disease, pregnancy, breast feeding, active bleeding, lesion in gastrointestinal tract, malignancy, hypoglycemia, hyperglycemia, consumption of any medication affecting gastrointestinal motility during two weeks prior to the study or during research period</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I23. I25</hc_code>
      <hc_code>I63, I65, </hc_code>
      <hc_code>J40, J41, </hc_code>
      <hc_code>I10, I11, </hc_code>
      <hc_code>G35</hc_code>
      <hc_code>163, 166</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic ischaemic heart disease, Chronic ischaemic heart disease,</hc_keyword>
      <hc_keyword>Cerebral infarction, Occlusion and stenosis of precerebral arteries, not resulting in cerebral infarction , Other cerebrovascular diseases</hc_keyword>
      <hc_keyword>Chronic lower respiratory diseases</hc_keyword>
      <hc_keyword>Essential (primary) hypertension , Hypertensive heart disease ,Secondary hypertension</hc_keyword>
      <hc_keyword>Demyelinating diseases of the central nervous system</hc_keyword>
      <hc_keyword>Cerebral infarction</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: 3ml ginger extract plus 40ml water through NGT, twice a day, will be added to the special food for the feeding via NG tube.</i_keyword>
      <i_keyword>Control group: 43 ml water, twice a day, as placebo, will be added to the special food for the feeding via NG tube.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Gastric residual volume. Timepoint: Every 3 hrs exactly before doing gavage. Method of measurement: by using 50cc gavage syringe.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The amount of energy received. Timepoint: Every 24 hours. Method of measurement: the amount of received gavage food (ml) is converted to calorie.</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>Golestan University Of Medical Sciences, Gorgan, Iran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-01-30</approval_date>
        <contact_name>Golestan University Of Medical Sciences, Gorgan, Iran</contact_name>
        <contact_address>Golestan University of medical Sciences, Bouyeh School of Nursing &amp; midwifery, Shastkola Road, Gorgan Gorgan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
