<?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>IRCT20130710013947N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-14</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>The effects and side effects of Cinnarizine and Bethahistine in The Treatment of Patients with Acute Peripheral Vertigo</public_title>
      <acronym></acronym>
      <scientific_title>The effects and side effects of Cinnarizine and Bethahistine in The Treatment of Patients with Acute Peripheral Vertigo</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36500</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly assigned to a study based on grading visits and inclusion criteria according to the required sample population. In the first of study, they were placed in a lacquer envelope and sealed in the research center. They were randomly assigned into 3 groups (betahistine and Placebo groups) Group B (Cinnarizine and Placebo Group) and Group C (Betahistine and cinnarizine) Random Allocation. The study blindness is done in such a way that random sequences are placed in closed envelopes at the nursing station, and the individual's in-person-based sequencing is carried out by the nurse of the department and the specialist does not know about the treatment. No information is available from the pocket. The nurse do not know anything about the illness level . The method of measuring vertigo symptoms is based on a questionnaire attached to the proposal (by a third person who has not played any role in the design of the research). Therefore, this study is a randomized, double blinded clinical trial study, Blinding description: Patients were randomly assigned to a study based on grading visits and inclusion criteria according to the required sample population. In the first of study, they were placed in a lacquer envelope and sealed in the research center. They were randomly assigned into 3 groups (betahistine and Placebo groups) Group B (Cinnarizine and Placebo Group) and Group C (Betahistine and cinnarizine) Random Allocation. The study blindness is done in such a way that random sequences are placed in closed envelopes at the nursing station, and the individual's in-person-based sequencing is carried out by the nurse of the department and the specialist does not know about the treatment. No information is available from the pocket. The nurse do not know anything about the illness level . The method of measuring vertigo symptoms is based on a questionnaire attached to the proposal (by a third person who has not played any role in the design of the research). Therefore, this study is a randomized, double blinded clinical trial study.</study_design>
      <phase>3</phase>
      <hc_freetext>Benign Positional Vertigo.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The first group was treated with cinnarizine 25 mg and placebo 3 times a day. Intervention 2: Intervention group: The second group received 1 week treatment with betahistine 8 mg and placebo 3 times a day. Intervention 3: Intervention group: The third group was treated for 1 week with 1 betahistine 8 mg and cinnarizine 25 mg 3 times daily.</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:
All data will published as article in journal without patients name

When:
After publication in journal

To whom:
After publication in journal

Conditions:
After publication in journal

Where to obtain:
It will be free or not depend on journal policy

How to obtain:
It will be free or not depend on journal policy

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Peyman Asadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>parastar street, rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4144666949</zip>
        <telephone>+98 13 3322 2444</telephone>
        <email>payman.asadi@yahoo.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr peyman Asadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>parastar street, rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4144666949</zip>
        <telephone>+98 13 3322 2444</telephone>
        <email>payman.asadi@yahoo.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age more than 18 years old
Age less than 60 years old
patients referred with Benign Positional Vertigo (BPV)
Did not use drug before reference</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Meniere syndrome
Vertigo caused by untreated primary organ disease
Pregnancy
Patients use Benzodiazepines, CNS suppressant, Barbiturates
History of internal and middle ear surgery
Migraine headaches
Headache at the time of study
A history of mental or neurological illness
Gastric ulcer and digestive problems</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H81.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Benign paroxysmal Positional vertigo</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The first group was treated with cinnarizine 25 mg and placebo 3 times a day</i_keyword>
      <i_keyword>Intervention group: The second group received 1 week treatment with betahistine 8 mg and placebo 3 times a day</i_keyword>
      <i_keyword>Intervention group: The third group was treated for 1 week with 1 betahistine 8 mg and cinnarizine 25 mg 3 times daily</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Rate of positional vertigo. Timepoint: At first, 3rd days and 1 week later. Method of measurement: Visual Analog Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Significance improvement. Timepoint: 3rd days and 1 week later after treatment. Method of measurement: Mean Vertigo Score (MVS).</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-31</approval_date>
        <contact_name>Ethics committee of Guilan University of medical Sciences</contact_name>
        <contact_address>Namjoo Street, Rasht, Guilan, Iran Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
