<?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>IRCT2015120722777N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-12-26</date_registration>
      <primary_sponsor>Vice chancellor for research,Arak University of Medical Sciences</primary_sponsor>
      <public_title>treatment of ataxia in patients with acute peripheral vertigo.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of diazepam and promethazine in relieving ataxia in patients with acute peripheral vertigo, a clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-08-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19574</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Simple randomization was performed by using a random number table.</study_design>
      <phase>3</phase>
      <hc_freetext>Acute peripheral vertigo.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1:&#13;
Patients with acute peripheral vertigo enroll to the study considering inclusion and exclusion criteria. First arm, include 35 patients who receive 5 mg of intravenous diazepam. The patients will reassessed 60 and 120 minutes after receiving the medication. The focus was on the effects of the medication on their ataxia, which was examined using both Romberg test and Tandem gait.  Systolic and diastolic blood pressure as well as heart rate were measured and recorded. The patients were also questioned regarding any of the common medication side effects. The results of both groups will be compared with each other and statistically analyzed. Intervention 2: Intervention 2: &#13;
Patients with acute peripheral vertigo enroll to the study considering inclusion and exclusion criteria. First arm, include 35 patients who receive 12.5 mg of intramuscular promethazine. The patients will reassessed 60 and 120 minutes after receiving the medication. The focus was on the effects of the medication on their ataxia, which was examined using both Romberg test and Tandem gait.  Systolic and diastolic blood pressure as well as heart rate were measured and recorded. The patients were also questioned regarding any of the common medication side effects. The results of both groups will be compared with each other and statistically analyzed.</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>Maryam Vakili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>A'lam-Al-Hoda Street, Shahid Shiroodi Street</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 86 3417 3601</telephone>
        <email>maryam.vakili.md@gmail.comabdolghader.pakniyat@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Morteza Qaribi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>A'lam-Al-Hoda Street, Shahid Shiroodi Street</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 86 3417 3601</telephone>
        <email>morteza.qaribi@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: aged between 18-60 years old; acute peripheral vertigo and ataxia.&#13;
exclusion criteria: history of syncope or cardiac event; considerations of a central origin for vertigo; focal neurological deficits; known pregnancy; evidence of drug-induced vertigo or orthostatic hypotension; known dystonic or adverse reaction to diazepam and promethazine or other similar agents; report of taking medication within 24 hours of ED presentation that might affect the results (e.g., antihistamines, antipsychotics, opioid analgesics or sedatives).</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H81.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Benign paroxysmal vertigo</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 1:&#13;
Patients with acute peripheral vertigo enroll to the study considering inclusion and exclusion criteria. First arm, include 35 patients who receive 5 mg of intravenous diazepam. The patients will reassessed 60 and 120 minutes after receiving the medication. The focus was on the effects of the medication on their ataxia, which was examined using both Romberg test and Tandem gait.  Systolic and diastolic blood pressure as well as heart rate were measured and recorded. The patients were also questioned regarding any of the common medication side effects. The results of both groups will be compared with each other and statistically analyzed.</i_keyword>
      <i_keyword>Intervention 2: &#13;
Patients with acute peripheral vertigo enroll to the study considering inclusion and exclusion criteria. First arm, include 35 patients who receive 12.5 mg of intramuscular promethazine. The patients will reassessed 60 and 120 minutes after receiving the medication. The focus was on the effects of the medication on their ataxia, which was examined using both Romberg test and Tandem gait.  Systolic and diastolic blood pressure as well as heart rate were measured and recorded. The patients were also questioned regarding any of the common medication side effects. The results of both groups will be compared with each other and statistically analyzed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ataxia. Timepoint: 60 and 120 minutes after intervention. Method of measurement: Romberg Test and tandem gait test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure. Timepoint: 60 and 120 minutes after intervention. Method of measurement: Sphygmomanometer.</sec_outcome>
      <sec_outcome>Heart Rate. Timepoint: 60 and 120 minutes after intervention. Method of measurement: Pulse oximetry.</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>Vice chancellor for research,Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-09-17</approval_date>
        <contact_name>Ethics committee of َArak University of Medical Sciences</contact_name>
        <contact_address>A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran Arak  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
