NCT01378650已完成不适用
A Randomized, Prospective, Placebo-controlled Double-blind, Pilot Study on the Effect of Cilostazol for 4 Weeks in Patients With Chronic Tinnitus
Jong Woo Chung1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change of the tinnitus handicap inventory (THI) score
研究概览
简要总结
- Overview of tinnitus Tinnitus is a noisy sound which is perceived without any external sound source. According to the survey of the US, 10-20% of adult have the symptom of tinnitus and 3-5% of tinnitus patients have severe discomfort of daily life. Severe tinnitus can result in psychiatric problems such as depression and anxiety disorders. Enhancement of environmental sound, hearing aids, sound generators, cognitive therapy, transcranial magnetic therapy, and drug therapy have been tried for treatment of tinnitus. Nitric oxide(NO) is a well-known neurotransmitter acting as a vasodilator through regulation of production of cyclic guanosine monophosphate(cGMP) and can be found in various sites of cochlea. It is reported that cGMP enhances activity of protein kinase A (PKA), a mediator of platelet aggregation inhibition and vasodilatation and results in increase of vascular flow.
- Characteristics of the clinical research drug, cilostazol Cilostazol inhibits phosphodiesterase type 3 (PDE3) selectively and increases amount of cAMP by inhibition of degradation of cyclic adenosine monophosphate(cAMP). cAMP again by increasing the active form of PKA suppress the production of blood clots and increase blood flow by expanding blood vessels. Anti-platelet activity and vasodilatation effect of cilostazol have been used for improvement of diabetic peripheral vascular disorders and suppression of stroke recurrence. Previous studies reported that by increasing the activity of NO and PKA, the blood flow of stria vascularis and cochlear hair cells can be improved. These studies implies that cilostazol, which causes inhibition of PDE3 and increase of PKA, can have a potential effect on improvement of tinnitus by increase of blood flow to peripheral cochlear cells. Thus, we hypothesized that cilostazol, which has been widely used for enhancing peripheral blood flow, can bring improvement of tinnitus by causing better peripheral blood flow of cochlea.
- The aim of the study We planned this study to validate the assumptions of the background. The aim of our study is whether administration of cilostazol can improve tinnitus in terms of subjective degree of symptoms in chronic tinnitus patients.
详细描述
- Clinical research methods
- Determination of eligibility by history taking, physical examination, pure tone audiometry, speech audiometry, and distortion product otoacoustic emission test.
- Randomization by random sequence generation
- Administration : cilostazol 100mg Bid 4 weeks for the study group and placebo tablet Bid 4 weeks for the control group.
- Evaluation battery: questionnaires (tinnitus handicap inventory, visual analogue scale, Quality of life SF-36)
- Time of evaluation : pre-administration, 2 weeks after administration, 4 week after administration
- Monitoring of side effects
- Evaluation of treatment response - Statistical analysis of scores of questionnaires using SPSS K12.0 (paired t-test for changes of each group and Mann-Whitney U test for comparing the mean scores of two groups)
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults of age over 19
- •Unilateral or bilateral tinnitus
- •Chronic tinnitus lasting more than 3 months
- •Initial visual analogue scale of tinnitus >3
排除标准
- •Conductive hearing loss on pure tone audiometry
- •Associated other inner ear diseases such as Meniere's disease
- •Objective or pulsatile tinnitus
- •Contraindication to anti-platelet drug
- •Any cardiac disease
- •Bleeding tendency and major operation within 3 months
- •Breastfeeding
- •Pregnancy
研究组 & 干预措施
Cilostazol group
Experimental
Administration of Cilostazol 100mg twice a day for 4 weeks
干预措施: Cilostazol (Drug)
Placebo group
Placebo Comparator
placebo drug twice a day for 4 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change of the tinnitus handicap inventory (THI) score
时间窗: within 2 weeks before administration, 2 weeks after administration, 4 week after administration
A Questionnaire for assessing subjective discomfort from chronic tinnitus
次要结局
- Changes of Quality of Life (SF-36) score(within 2weeks before administration, 2 weeks after administration, 4 weeks after administration)
- Change of the visual analogue scale (VAS) score(within 2 weeks before administration, 2 weeks after administration, 4 week after administration)
研究者
Jong Woo Chung
MD
Asan Medical Center
研究点 (1)
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