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临床试验/NCT02098330
NCT02098330已完成3 期

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

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
40
试验地点
1
主要终点
The improvement in vestibular function test (caloric & videop HIT) after treatment

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ages over 18 years
  • Acute vertigo that occurred within 7 days
  • The spontaneous nystagmus should be detected
  • Caloric weakness over 20%

排除标准

  • 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

研究组 & 干预措施

: Ginkgo biloba & methylprednisolone

Active Comparator

Patients receive Ginkgo biloba & methylprednisolone per oral.

干预措施: Ginkgo biloba & Methylprednisolone (Drug)

Ginkgo biloba

Placebo Comparator

Patients receive Ginkgo biloba per oral.

干预措施: Ginkgo biloba (Drug)

结局指标

主要结局

The improvement in vestibular function test (caloric & videop HIT) after treatment

时间窗: 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).

次要结局

  • The improvement in dizziness handicap inventory after treatment(The first results were collected at initial diagnosis. And following results were collected 6 months after the first exam.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hong Ju Park

Professor

Asan Medical Center

研究点 (1)

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