Effect of Renexin Tablet in Patients With Recurrent Vestibulopathy

Phase 3TerminatedNCT01895400

Jong Woo Chung26 enrolled

Overview

The purpose of this study is to determine whether Renexin is effective in the treatment of vestibular symptoms in patients with recurrent vestibulopathy.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Recurrent Vestibulopathy

Interventions

Renexin (cilostazol 100mg + gingko biloba extract 80 mg)DRUG

Take Renexin 1T bid po medication for 8 weeks

PlaceboDRUG

Take placebo drug 1T bid po medication for 8 weeks

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Asan Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

equilibrium score of dynamic posturography

compared with pretreatment equilibrium score

Time frame: after 8 weeks of treatment

Secondary Outcomes

dizziness handicap inventory

compared with pretreatment DHI score

Time frame: at 4 weeks, 8 weeks after treatment

visual analogue scale (VAS) of vertigo

compared with pretreatment VAS score

Time frame: at 4 weeks, 8 weeks after treatment

Questionnaire for Quality of life (SF36)

compared with pretreatment SF36 score

Time frame: at 4 weeks, 8 weeks after treatment

Data from ClinicalTrials.gov

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