Recurrent Vestibulopathy
Conditions
Keywords
Renexin for Recurrent Vestibulopathy
Brief summary
The purpose of this study is to determine whether Renexin is effective in the treatment of vestibular symptoms in patients with recurrent vestibulopathy.
Detailed description
1. Study design * Among patients who visitied for recurrent vertigo more than 3 months, patients will be included after ruling out other peripheral vertigo through history taking, physical examination, Dix-Hallpike test, head-thrust test. * Included patients will go through permission, laboratory tests (CBC, chemical battery, coagulation battery, urine HCG (only women of childbearing age), posturography. During patients selection period for inclusion(2 weeks), taking medication for vertigo is prohibited. * Included patients will be randomized to Treatment group (Renexin) and Placebo group. * All patients before treatment will do dizziness handicap inventory(DHI), visual analogue scale (VAS) for vertigo, questionnaire for quality of life (SF36). * After 4 weeks(+-\ 3 days) of drug administration, DHI, VAS for vertigo, SF36 will be done for drug compliance and side effects. * After 8 weeks(+-\ 3 days) of drug administration, posturography, DHI, VAS for vertigo, SF36 will be done for drug compliance and side effects. * For control of severe vertigo during drug administration, Valium 2mg can be used as a salvage treatment, and number of valium administration will be checked at every visit. 2. Statistical analysis * As a statistical analysis, paired T-test will be used to compare equilibrium score, DHI, VAS, SF-36. When p-value is \<0.05, it will be considered as significant difference.
Interventions
DRUGRenexin (cilostazol 100mg + gingko biloba extract 80 mg)
Take Renexin 1T bid po medication for 8 weeks
DRUGPlacebo
Take placebo drug 1T bid po medication for 8 weeks
Sponsors
SK Chemicals Co., Ltd.
Asan Medical Center
Jong Woo Chung
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Recurrent vestibulopathy patient with symptoms more than 3 months of recurrent vertigo * Visual analogue scale (VAS) score between 4 to 8
Exclusion criteria
* Showing signs of central lesion in MRI or neurologic exams * central nystagmus or loss of consciousness with vertigo * cerebellar symptoms such as ataxia, dysarthria, gait disturbance * Diagnosed as peripheral vertigo such as benign paroxysmal positional vertigo, Meniere's disease, migrainous vertigo in recent 3 months * Bilateral vestibular dysfunction * Vestibular neuronitis symptom appeared in recent 6 months * Chronic liver disease (ALT\>100 or AST\>100) or chronic kidney disease (Creatinine \> 3.0 mg) * Blood Hemoglobin \< 10mg/dl (in male) or \< 8 mg/dl (in female) * Contraindication for testing drug (ex. Pregnancy or breast feeding etc.) * Taking antiepileptics such as phenobarbital, phenytoin, carbamazepine or rifampin in recent 2 weeks * Taking cilostazol, gingko biloba for other disease * Allergy/hypersensitivity to Renexin * Severe drug toxicity when taking Renexin previously
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| equilibrium score of dynamic posturography | after 8 weeks of treatment | compared with pretreatment equilibrium score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| dizziness handicap inventory | at 4 weeks, 8 weeks after treatment | compared with pretreatment DHI score |
| visual analogue scale (VAS) of vertigo | at 4 weeks, 8 weeks after treatment | compared with pretreatment VAS score |
| Questionnaire for Quality of life (SF36) | at 4 weeks, 8 weeks after treatment | compared with pretreatment SF36 score |
Countries
South Korea
Outcome results
None listed