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CompletedNCT02098330Updated Jan 10, 2019

The Efficacy of Steroid Therapy in Vestibular Neuritis

A Phase 3 interventional study of Ginkgo biloba & Methylprednisolone and Ginkgo biloba in Vestibular Neuritis, sponsored by Asan Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-01-10.

Sponsored by Asan Medical Center · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Vestibular Neuritis

Keywords

  • Vestibular neuritis
  • Vertigo
  • Head impulse test
  • Steroid
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In context

Vestibular Neuronitis

34 studies on the registry are indexed under Vestibular Neuronitis; 4 are open to participants now.

This study's enrollment of 40 is below the median of 50 across 27 interventional studies indexed under Vestibular Neuronitis.

Browse Vestibular Neuronitis studies →

Lead sponsor

Asan Medical Center is the lead sponsor of 578 studies on the registry; 73 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    : Ginkgo biloba & methylprednisolone

    Patients receive Ginkgo biloba \& methylprednisolone per oral.

    Drug: Ginkgo biloba & Methylprednisolone

  • Placebo comparator
    Ginkgo biloba

    Patients receive Ginkgo biloba per oral.

    Drug: Ginkgo biloba

Interventions

  • DrugGinkgo biloba & Methylprednisolone

    Drug pages: Ginkgo biloba extract · 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.

    Also known as: Ginexin, Methylprednisolone

  • DrugGinkgo biloba

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

    Also known as: Ginexin

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What researchers measure

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).

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

    Time frame: The first results were collected at initial diagnosis. And following results were collected 6 months after the first exam.

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Study locations

1 site
  • Asan Medical Center
    Seoul, Songpa-gu 138-736, Korea, Republic of
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References and documents

Publications

  • 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. PubMed 28391531 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02098330
Responsible party
Hong Ju Park (Professor, Asan Medical Center) — Principal investigator
First posted
Mar 28, 2014
Start date
Mar 2014
Primary completion
Dec 2014
Completion
Jun 2015
Last update
Jan 10, 2019

Study contacts

Hong Ju Park, Professor
study director · Asan Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Ginkgo biloba extract · Methylprednisolone

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