Overview

This trial is active, not recruiting.

Condition vestibular neuritis
Treatments ginkgo biloba & methylprednisolone, ginkgo biloba
Phase phase 3
Sponsor Asan Medical Center
Start date March 2014
End date June 2015
Trial size 60 participants
Trial identifier NCT02098330, SVNHIT_kr

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Patients receive Ginkgo biloba & methylprednisolone per oral.
ginkgo biloba & methylprednisolone Ginexin
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.
(Placebo Comparator)
Patients receive Ginkgo biloba per oral.
ginkgo biloba Ginexin
Ginkgo biloba 160 mg/day (per oral, 80 mg twice a day) for 1 month.

Primary Outcomes

Measure
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.

Secondary Outcomes

Measure
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.

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title The Efficacy of Steroid Therapy in Vestibular Neuritis Confirmed by Head Impulse Test: Prospective Randomized Controlled Study
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Asan Medical Center.