<?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>IRCT20171221037984N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-06</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>1.	Comparing the effectiveness of intravenous promethazine and diazepam</public_title>
      <acronym>ipd</acronym>
      <scientific_title>1.	Comparing the effectiveness of intravenous promethazine and diazepam in treating peripheral vertigo in patients who have referred to Emergency Unit of Baqiatullah (may Allah hasten his honorable appearance) Hospital during the time span from 2015 to 2016</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>164</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28749</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Other, Randomization description: 9.	In such a way that the patients are asked to score their intensity of vertigo in a range from one to ten. Next, the patients will be randomly assigned to two groups (by the use of random numbers table). Then, one group will be treated by the use of intravenous promethazine (25 mg/ml) and the other will be subjected to IV diazepam (5mg/ml) treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Patients with peripheral vertigo.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: the peripheral vertigo individuals who had referred to the emergency unit were subjected to treatment by IV promethazine for a dosage of 25mg/ml. Intervention 2: Control group:  the peripheral vertigo individuals who had referred to the emergency unit were subjected to treatment by IV diazepam for a dosage of 5mg/ml.</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:
Research and Ethics Committee Office of Shahid Beheshti University of Medical Sciences

When:
100 DAY

To whom:
Dr. Kamran Haidari

Conditions:
Dr. Kamran Haidari

Where to obtain:
33.	Sayyed Mohsen Fayyazi

How to obtain:
Patients with peripheral vertigo

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Kamran Haidari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tajrish Square, Shohaday-e-Tajrish Hospital</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7158896858</zip>
        <telephone>+98 21 2661 8710</telephone>
        <email>Heidari-k@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hamid Reza Javadzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vanak Square, Baqiatullah (may Allah hasten his honorable appearance) Hospital</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7158896859</zip>
        <telephone>+98 21 2661 8711</telephone>
        <email>nabizadehfaezeh85@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>7.	The individuals, above 18 years of age, with motion sickness (peripheral vertigo) who have referred to emergency unit. The exclusion criteria are: expressing dissatisfaction to participate in the study, pregnant women, history of allergy to the drugs administered in the study, a history of taking antivertigo drugs during the past 24 hours, development of drug-induced motion sickness symptoms, existence of central vertigo and a history of traumatic brain injury. The abovementioned cases can be diagnosed in examinations and the patients’ self-report</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H81.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other peripheral vertigo</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: the peripheral vertigo individuals who had referred to the emergency unit were subjected to treatment by IV promethazine for a dosage of 25mg/ml.</i_keyword>
      <i_keyword>Control group:  the peripheral vertigo individuals who had referred to the emergency unit were subjected to treatment by IV diazepam for a dosage of 5mg/ml.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Vertigo Treatment. Timepoint: 365 DAYS. Method of measurement: The Effectiveness OF Promethazine And Diazepam In tThe Treatment Of Peripheral Vertigo.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The individuals who had referred to the emergency unit were asked to complete the demographic characteristic and visual analog scale (VAS) forms; in such a way that the patients were asked to give a number from 1 to 12 to the intensity of vertigo they experience. In the next stage, the patients were randomly assigned to two groups (based on random numbers table). Afterwards, the first group was given IV promethazine (25 mg/ml) and the second group received IV diazepam (5mg/ml). The patients were asked to fill in the VAS form two hours after being administered with the drugs. The drug-induced symptoms, if any, were recorded in the questionnaire form. In case that the patients do not respond to the treatment favorably, a second dosage of the same drug will be prescribed. Timepoint: 25 and 5. Method of measurement: the first group was given IV promethazine (25 mg/ml) and the second group received IV diazepam (5mg/ml). The patients were asked to fill in the VAS form two hours after being administered with the drugs. The drug-induced symptoms, if any, were recorded in the questionnaire form. In case that the patients do not respond to the treatment favorably, a second dosage of the same drug will be prescribed.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-03-30</approval_date>
        <contact_name>Research and Ethics Committee Office of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Building Block One: No.5, ground floor, Medical Department, Shahid Beheshti Medical sciences University, Velenjak St., beside Taleqani Hospital, Tehran, Iran tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-03-29</approval_date>
        <contact_name>Research and Ethics Committee Office of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>31.	Vanak Square, Baqiatullah (may Allah hasten his honorable appearance) Hospital تهران Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
