The Efficacy of Steroid Therapy in Vestibular Neuritis

Phase 3

Completed

• Conditions: Vestibular Neuritis
• Interventions: Drug: Ginkgo biloba & Methylprednisolone; Drug: Ginkgo biloba

• Registration Number: NCT02098330
• Lead Sponsor: Asan Medical Center

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.

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 Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-21
• Study First Submitted QC: 2014-03-25
• Study First Posted: 2014-03-28
• Primary Completion: 2014-12
• Study Completion: 2015-06
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
: Ginkgo biloba & methylprednisolone	Ginkgo biloba & Methylprednisolone	Patients receive Ginkgo biloba \& methylprednisolone per oral.
Ginkgo biloba	Ginkgo biloba	Patients receive Ginkgo biloba per oral.

Primary Outcome Measures

Name	Time	Method
The improvement in vestibular function test (caloric & videop HIT) after treatment	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).

Secondary Outcome Measures

Name	Time	Method
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.	The effectiveness of steroid therapy was determined by comparing improvement of subjective symptoms (symptom score by DHI) in each group.

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Songpa-gu, Korea, Republic of