The Efficacy of Steroid Therapy in Vestibular Neuritis

NCT ID: NCT02098330

Last Updated: 2019-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Vestibular Neuritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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: Ginkgo biloba & methylprednisolone

Patients receive Ginkgo biloba \& methylprednisolone per oral.

Group Type ACTIVE_COMPARATOR

Ginkgo biloba & Methylprednisolone

Intervention Type DRUG

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

Patients receive Ginkgo biloba per oral.

Group Type PLACEBO_COMPARATOR

Ginkgo biloba

Intervention Type DRUG

Ginkgo biloba 160 mg/day (per oral, 80 mg twice a day) for 1 month.

Interventions

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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.

Intervention Type DRUG

Ginkgo biloba

Ginkgo biloba 160 mg/day (per oral, 80 mg twice a day) for 1 month.

Intervention Type DRUG

Other Intervention Names

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Ginexin Methylprednisolone Ginexin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Hong Ju Park

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hong Ju Park, Professor

Role: STUDY_DIRECTOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, Songpa-gu, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 28391531 (View on PubMed)

Other Identifiers

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SVNHIT_kr

Identifier Type: -

Identifier Source: org_study_id

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