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
|Condition or disease||Intervention/treatment||Phase|
|Vestibular Neuritis||Drug: Ginkgo biloba & Methylprednisolone Drug: Ginkgo biloba||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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
- 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).
- 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.
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
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Songpa-gu, Korea, Republic of, 138-736|
|Study Director:||Hong Ju Park, Professor||Asan Medical Center|