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The Efficacy of Steroid Therapy in Vestibular Neuritis

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ClinicalTrials.gov Identifier: NCT02098330
Recruitment Status : Completed
First Posted : March 28, 2014
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Hong Ju Park, 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.

Condition or disease Intervention/treatment Phase
Vestibular Neuritis Drug: Ginkgo biloba & Methylprednisolone Drug: Ginkgo biloba Phase 3

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Steroid Therapy in Vestibular Neuritis Confirmed by Head Impulse Test: Prospective Randomized Controlled Study
Study Start Date : March 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : June 2015


Arm Intervention/treatment
Active Comparator: : Ginkgo biloba & methylprednisolone
Patients receive Ginkgo biloba & methylprednisolone per oral.
Drug: 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.
Other Names:
  • Ginexin
  • Methylprednisolone

Placebo Comparator: Ginkgo biloba
Patients receive Ginkgo biloba per oral.
Drug: Ginkgo biloba
Ginkgo biloba 160 mg/day (per oral, 80 mg twice a day) for 1 month.
Other Name: Ginexin




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02098330


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Songpa-gu, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
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Study Director: Hong Ju Park, Professor Asan Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hong Ju Park, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02098330    
Other Study ID Numbers: SVNHIT_kr
First Posted: March 28, 2014    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Keywords provided by Hong Ju Park, Asan Medical Center:
Vestibular neuritis
Vertigo
Head impulse test
Steroid
Additional relevant MeSH terms:
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Vestibular Neuronitis
Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Cranial Nerve Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents