The Efficacy of Steroid Therapy in Vestibular Neuritis
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study was to compare the treatment effectiveness of steroid therapy for vestibular neuritis by using video head impulse test.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2014
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 21, 2014
CompletedFirst Posted
Study publicly available on registry
March 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJanuary 10, 2019
January 1, 2019
9 months
March 21, 2014
January 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The improvement in vestibular function test (caloric & videop HIT) after treatment
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 Outcomes (1)
The improvement in dizziness handicap inventory after treatment
The first results were collected at initial diagnosis. And following results were collected 6 months after the first exam.
Study Arms (2)
: Ginkgo biloba & methylprednisolone
ACTIVE COMPARATORPatients receive Ginkgo biloba \& methylprednisolone per oral.
Ginkgo biloba
PLACEBO COMPARATORPatients receive Ginkgo biloba per oral.
Interventions
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.
Ginkgo biloba 160 mg/day (per oral, 80 mg twice a day) for 1 month.
Eligibility Criteria
You may qualify if:
- Ages over 18 years
- Acute vertigo that occurred within 7 days
- The spontaneous nystagmus should be detected
- Caloric weakness over 20%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asan Medical Center
Seoul, Songpa-gu, 138-736, South Korea
Related Publications (1)
Yoo MH, Yang CJ, Kim SA, Park MJ, Ahn JH, Chung JW, Park HJ. Efficacy of steroid therapy based on symptomatic and functional improvement in patients with vestibular neuritis: a prospective randomized controlled trial. Eur Arch Otorhinolaryngol. 2017 Jun;274(6):2443-2451. doi: 10.1007/s00405-017-4556-1. Epub 2017 Apr 8.
PMID: 28391531DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hong Ju Park, Professor
Asan Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 21, 2014
First Posted
March 28, 2014
Study Start
March 1, 2014
Primary Completion
December 1, 2014
Study Completion
June 1, 2015
Last Updated
January 10, 2019
Record last verified: 2019-01