Effect of Renexin Tablet in Patients With Recurrent Vestibulopathy

Study Overview
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Brief Summary
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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
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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. 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.

Official Title
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A Single-center, Prospective, Randomized, Parallel Group, Placebo-controlled Exploratory Study on the Effect of Renexin Tablet in Patients With Recurrent Vestibulopathy

Conditions
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Recurrent Vestibulopathy

Intervention / Treatment
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* Drug: Renexin (cilostazol 100mg + gingko biloba extract 80 mg)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Renexin<br>Renexin 1T bid for 12 weeks | Drug: Renexin (cilostazol 100mg + gingko biloba extract 80 mg)<br>* Take Renexin 1T bid po medication for 8 weeks<br>* Other names: Renexin;|
| Placebo Comparator: Placebo<br>Placebo 1T bid for 12 weeks | Drug: Placebo<br>* Take placebo drug 1T bid po medication for 8 weeks<br>* Other names: Renexin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| equilibrium score of dynamic posturography | compared with pretreatment equilibrium score | after 8 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dizziness handicap inventory | compared with pretreatment DHI score | at 4 weeks, 8 weeks after treatment | 
| visual analogue scale (VAS) of vertigo | compared with pretreatment VAS score | at 4 weeks, 8 weeks after treatment | 
| Questionnaire for Quality of life (SF36) | compared with pretreatment SF36 score | at 4 weeks, 8 weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renexin for Recurrent Vestibulopathy