<?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>IRCT20191007045013N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-29</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of Granisetron and Ondansetrone on nausea and vomiting in adult patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Granisetron and Ondansetrone on nausea and vomiting in adult patients referred to the emergency department</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42886</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patient  will randomly divide  into two groups according to the method of quadratic random block permutation,after sorting patients by computer ,the number of each patient and the drug combination used will be identified and the drugs packaged in packages, only the number on each envelope is that the executor and the nurse are unaware of its contents and the list of medicines is only available to the researcher, Blinding description: In this randomized controlled trial, patients are given one of two drugs, Granisetron or Ondansetron, which has no information about the type of drug used by the patient, the injector, and the person examining the effects of the drug. (Patient informed consent to participate in this study and randomized injection of either drug).</study_design>
      <phase>3</phase>
      <hc_freetext>Nausea and vomiting in patients admitted to the emergency department.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group was injected with a conscious consent of 4 mg intravenous Ondansetron(Tehran chemistry company product) in single dose and   nausea and vomiting are  measure 15,30,45,60,75,90 minutes after to take Ondansetron by visual analogue scale method   and questionnaire . Intervention 2: The second intervention group was injected with a conscious consent of 1 mg intravenous Granisetron(Aboureihan company product)  in single dose and    nausea and vomiting are  measure 15,30,45,60,75,90 minutes after to take Granisetron by visual analogue scale method   and questionnaire .</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:
Patient information including nausea and vomiting and associated symptoms that the patient has been referred to, how to use the medication and its effects on patients recorded through the questionnaire, and the patient's informed consent to participate in the study. But the names of study participants are not shared for patient privacy.

When:
The start of the access period after the end of the job is the result of the confirmation.

To whom:
It will be accessible to everyone.

Conditions:
Use nausea and vomiting or granisetron or ondansetron or emergency keywords to access this study.

Where to obtain:
Email your requests to
alivefagh@yahoo.com.

How to obtain:
Request email to study person.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alivefagh Nematollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emergency Medicine ,Imam Khomeini training center,Azadegan Ave</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6193673111</zip>
        <telephone>+98 61 3222 9166</telephone>
        <email>alivefagh@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alivefagh Nematolahy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emergency Medicine, Imam Khomeini Training Center, Azadegan Ave</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6193673111</zip>
        <telephone>+98 61 3222 9166</telephone>
        <email>Alivefagh@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Nausea and vomiting in adult patients</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with symptoms such as headaches, lateralized symptoms, and unstable vital signs.
Patients who have chest pain or ECG changes.
Patients with symptoms of Rise ICP.
Patients who have been taking sertonin (eg, fluoxetine, doxepin, isomerboxazide, amitriptyline, etc.) in the past few days.
Patients who have used hepatic cytochrome P450 enzyme stimulating drugs or liver enzyme inhibitors in recent days.
Patients who have consumed grapefruit in the past 24 hours
Patient does not consent to attend or continue treatment.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nausea and vomiting</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>The first intervention group was injected with a conscious consent of 4 mg intravenous Ondansetron(Tehran chemistry company product) in single dose and   nausea and vomiting are  measure 15,30,45,60,75,90 minutes after to take Ondansetron by visual analogue scale method   and questionnaire .</i_keyword>
      <i_keyword>The second intervention group was injected with a conscious consent of 1 mg intravenous Granisetron(Aboureihan company product)  in single dose and    nausea and vomiting are  measure 15,30,45,60,75,90 minutes after to take Granisetron by visual analogue scale method   and questionnaire .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nausea. Timepoint: 15minute ,30minute,45minute,60minute,75 minute,90minute   after  to take Granisetron or Ondansetron. Method of measurement: Using a visual analogue scaling  method where the patient signs a nausea rate on a line measuring 10 cm in length from zero to ten.</prim_outcome>
      <prim_outcome>Vomiting. Timepoint: 15,30,45,60,75,90minute after to take Granisetron or Ondansetron. Method of measurement: Count the number of vomiting.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-08-04</approval_date>
        <contact_name>Ethics committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard, Ahvaz, Iran Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
