<?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>IRCT20170609034406N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-23</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of smelling peppermint essential oil on patients with nausea referred to emergency department of Sina Hospital</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of smelling peppermint essential oil on patients with nausea referred to emergency department of Sina Hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>168</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50202</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, Permuted Block Randomization method was used for entering patients in control and treatment groups.
Random method and description of each method: simple randomization, block
Arrange the accident stages: 
1) Determine the volume of each block (blocks of 6)
2) Prepare a list of 90 blocks and assign numbers to them
  AABBCC(1)      ABCBAC(2)      ABCCBA(3)     ...    CBAABC(90)
3) Choosing 28 random numbers between 1 and 90
4) Identification of the Treatment Assignment, Blinding description: This study was conducted in a single blind clinical trial. None of the people distributing drugs and patients were aware of which patients received the drug or placebo of Ondansetron, and were only diagnosed with the numbers given by the system to the patients.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: nausea. Condition 2: vomiting. Condition 3: pain. Condition 4: Duration of being in the emergency department. Condition 5: Patient satisfaction at discharge from emergency ward.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The first treatment group consists of 56 patients receiving inhaled peppermint essential oil 3 times and oral placebo (which apart from the active ingredient,were similar to ondansetron tablets) for 2 minutes. Intervention 2: Intervention group: The second treatment group consists of 56 patients receiving 4 mg oral ondansetron and inhaled peppermint essential oil 3 times for 2 minutes. Intervention 3: Control group:Control group consists of 56 patients receiving 4 mg oral ondansetron and inhaled saline solution placebo (which apart from the active ingredient,were similar to peppermint essential oil) 3 times for 2 minutes.</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 Threre is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Afshin Gharekhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Pharmacy , Tabriz University of Medical Science , Daneshgah Street , Tabriz , Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5147663419</zip>
        <telephone>+98 41 3230 5351</telephone>
        <email>gharekhania@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Afshin Gharekhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Pharmacy , Tabriz University of Medical Science , Daneshgah Street , Tabriz , Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5147663419</zip>
        <telephone>+98 41 3230 5153</telephone>
        <email>gharekhania@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18 years
Ability to understand and sign a consent form
self-reported nausea severity of 3 or greater on a verbal numeric response scale (range 0 to 10)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>known allergy to peppermint essential oil
inability to inhale through the nares ( include rhinitis)
recent intake of antivomiting medications including Ondansetron, Metoclopramide, Granisetron, Domperidone
clinical suspicion for serotonin syndrome
pregnancy
Changing the state of consciousness so as to prevent the understanding and signing of the informed consent form</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R11</hc_code>
      <hc_code>R11</hc_code>
      <hc_code>R52</hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nausea and vomiting</hc_keyword>
      <hc_keyword>Nausea and vomiting</hc_keyword>
      <hc_keyword>Pain, unspecified</hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The first treatment group consists of 56 patients receiving inhaled peppermint essential oil 3 times and oral placebo (which apart from the active ingredient,were similar to ondansetron tablets) for 2 minutes.</i_keyword>
      <i_keyword>Intervention group: The second treatment group consists of 56 patients receiving 4 mg oral ondansetron and inhaled peppermint essential oil 3 times for 2 minutes.</i_keyword>
      <i_keyword>Control group:Control group consists of 56 patients receiving 4 mg oral ondansetron and inhaled saline solution placebo (which apart from the active ingredient,were similar to peppermint essential oil) 3 times for 2 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nausea score. Timepoint: Immediately before intervention. 5،10،20،30،60 minutes after the intervention. Method of measurement: Verbal Numeric Scale.</prim_outcome>
      <prim_outcome>Vomiting frequency. Timepoint: Immediately before intervention. 5،10،20،30،60 minutes after the intervention. Method of measurement: Standard questionnaire.</prim_outcome>
      <prim_outcome>Pain score. Timepoint: Immediately before intervention. 5،10،20،30،60 minutes after the intervention. Method of measurement: Verbal Numeric Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of being in the emergency department. Timepoint: after the intervention. Method of measurement: previously designed checklist for recording the time.</sec_outcome>
      <sec_outcome>Patient satisfaction at discharge from emergency ward. Timepoint: after the intervention. Method of measurement: previously designed checklist for recording patient satisfaction.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-08-21</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>No 2 Central Building , Tabriz University of Medical Sciences , Golgasht Street , Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
