The Efficacy of Steroid Therapy in Vestibular Neuritis

January 8, 2019 updated by: Hong Ju Park, Asan Medical Center

The Efficacy of Steroid Therapy in Vestibular Neuritis Confirmed by Head Impulse Test: Prospective Randomized Controlled Study

The purpose of this study was to compare the treatment effectiveness of steroid therapy for vestibular neuritis by using video head impulse test.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was a prospective, randomized controlled study. The enrolled vestibular neuritis patients were randomized to conservative treatment or steroid treatment when they are diagnosed with caloric test. After initial vestibular work-up including caloric, video head impulse tests, and a questinnaire (DHI), the patient was examined with the same tests again at 6 months later. The efficacy of steroid for the patients with vestibular neuritis would be determined by the comparison of the data of each group.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Songpa-gu
      • Seoul, Songpa-gu, Korea, Republic of, 138-736
        • Asan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ages over 18 years
  • Acute vertigo that occurred within 7 days
  • The spontaneous nystagmus should be detected
  • Caloric weakness over 20%

Exclusion Criteria:

  • Suspicious or verified a central nervous system lesion
  • If the patient has denied.
  • Other otologic disease (acute/chronic otitis media, otosclerosis, etc)
  • The patient with history of otologic surgery
  • The patient with history of brain surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: : Ginkgo biloba & methylprednisolone
Patients receive Ginkgo biloba & methylprednisolone per oral.
Drug: Ginkgo biloba & Methylprednisolone
Ginkgo biloba 160 mg/day (per oral, 80 mg twice a day) for 1 month. Methylprednisolone 48 mg/day(per oral, once a day for first 9 days. And then methylprednisolone tapering was started every 2 days. The entire duration of methylprednisolone treatment was 14 days.
Other Names:
  • Methylprednisolone
  • Ginexin
Placebo Comparator: Ginkgo biloba
Patients receive Ginkgo biloba per oral.
Drug: Ginkgo biloba
Ginkgo biloba 160 mg/day (per oral, 80 mg twice a day) for 1 month.
Other Names:
  • Ginexin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The improvement in vestibular function test (caloric & videop HIT) after treatment
Time Frame: The first results were collected at initial diagnosis. And following results were collected 6 months after the first exam.
The effectiveness of steroid therapy was determined by comparing the improvement of vestibular function (the degree of canal paresis by caloric test; gain and presence of refixation-saccade by video HIT test).
The first results were collected at initial diagnosis. And following results were collected 6 months after the first exam.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The improvement in dizziness handicap inventory after treatment
Time Frame: The first results were collected at initial diagnosis. And following results were collected 6 months after the first exam.
The effectiveness of steroid therapy was determined by comparing improvement of subjective symptoms (symptom score by DHI) in each group.
The first results were collected at initial diagnosis. And following results were collected 6 months after the first exam.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Study Director: Hong Ju Park, Professor, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

March 21, 2014

First Submitted That Met QC Criteria

March 25, 2014

First Posted (Estimate)

March 28, 2014

Study Record Updates

Last Update Posted (Actual)

January 10, 2019

Last Update Submitted That Met QC Criteria

January 8, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SVNHIT_kr

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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