The Efficacy of Steroid Therapy in Vestibular Neuritis
Primary Purpose
Vestibular Neuritis
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ginkgo biloba & Methylprednisolone
Ginkgo biloba
Sponsored by
About this trial
This is an interventional treatment trial for Vestibular Neuritis focused on measuring Vestibular neuritis, Vertigo, Head impulse test, Steroid
Eligibility 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
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
: Ginkgo biloba & methylprednisolone
Ginkgo biloba
Arm Description
Patients receive Ginkgo biloba & methylprednisolone per oral.
Patients receive Ginkgo biloba per oral.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02098330
Brief Title
The Efficacy of Steroid Therapy in Vestibular Neuritis
Official Title
The Efficacy of Steroid Therapy in Vestibular Neuritis Confirmed by Head Impulse Test: Prospective Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Neuritis
Keywords
Vestibular neuritis, Vertigo, Head impulse test, Steroid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
: Ginkgo biloba & methylprednisolone
Arm Type
Active Comparator
Arm Description
Patients receive Ginkgo biloba & methylprednisolone per oral.
Arm Title
Ginkgo biloba
Arm Type
Placebo Comparator
Arm Description
Patients receive Ginkgo biloba per oral.
Intervention Type
Drug
Intervention Name(s)
Ginkgo biloba & Methylprednisolone
Other Intervention Name(s)
Ginexin, Methylprednisolone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ginkgo biloba
Other Intervention Name(s)
Ginexin
Intervention Description
Ginkgo biloba 160 mg/day (per oral, 80 mg twice a day) for 1 month.
Primary Outcome Measure Information:
Title
The improvement in vestibular function test (caloric & videop HIT) after treatment
Description
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 Outcome Measure Information:
Title
The improvement in dizziness handicap inventory after treatment
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Ju Park, Professor
Organizational Affiliation
Asan Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-gu
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
28391531
Citation
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.
Results Reference
derived
Learn more about this trial
The Efficacy of Steroid Therapy in Vestibular Neuritis
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