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Completed

NCT Number: NCT02098330

The Efficacy of Steroid Therapy in Vestibular Neuritis

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

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Key information

Conditions

Vestibular Neuritis Cranial Nerve Diseases Ear Diseases Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Retrocochlear Diseases Signs and Symptoms Vertigo Vestibular Diseases Vestibular Neuronitis Vestibulocochlear Nerve Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asan Medical Center

Seoul, Songpa-gu, 138-736, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ginkgo biloba & Methylprednisolone

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.

Other names: Ginexin, Methylprednisolone

Ginkgo biloba

Drug

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

Other names: Ginexin

Primary outcomes

  1. 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.

    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 outcomes

  1. 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.

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

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

The Efficacy of Steroid Therapy in Vestibular Neuritis Confirmed by Head Impulse Test: Prospective Randomized Controlled Study

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Mar 28, 2014
Registry last updated
Jan 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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