EFFICACY AND SAFETY OF CAROVERINE VERSUS AMITRIPTYLINE IN TREATMENT OF TINNITUS.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The change in the severity of tinnitus after treatment in patients with tinnitus according to THI scoring at 2 months.
研究概览
简要总结
•Tinnitus may be defined as conscious awareness of a sound in the absence of an external auditory stimulus.
•Tinnitus may be categorised as subjective, objective, primary or secondary. The assessment of tinnitus begins by determining which of these types the patient present with.
•Being described its prevalence has been estimated to be as high as 32% in the adult population, with approximately 13%-17% reporting bothersome tinnitus.
•A wide variety of drugs have been used off-label to treat tinnitus sufferers, with limited effect.
•NMDA (N-methyle-D-aspartate)and AMPA(alpha-amino-3-hydroxy-5-methyle-4-isoxazolepropionic acid) receptors both are ionotropic glutamate receptor subtypes which are present in afferent nerve fibers of inner hair
cell are targeted for the therapy of tinnitus.
•Caroverine, is a class B calcium-channel-blocker that exhibits competitive AMPA antagonism, and noncompetitive NMDA antagonism.
•The pharmacologic effects of Amitriptyline a tricyclic antidepressants-act on various neurotransmitter receptors and endorphin pathways decreases the cochlear potential and decreased production of endolymph.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •The patients complaining of tinnitus affecting quality of life i.e. THI scoring more than
- •Idiopathic tinnitus.
排除标准
- •Vascular lesions of head and inner ear, ICSOL.
- •Secondary causes of tinnitus.
- •Eg.external ear and middle ear pathologies, patient on ototoxic drugs.
- •Patients not willing to give written consent after receiving due instructions.
- •Contra-indication for caroverine therapy (e.g. severe hypertension) Pregnancy or plan for having children Status post psychiatric therapy.
结局指标
主要结局
The change in the severity of tinnitus after treatment in patients with tinnitus according to THI scoring at 2 months.
时间窗: 8 Weeks
次要结局
- THI scoring at 1 month(The safety of caroverine versus amitriptyline according to CTCAE (Common Terminology Criteria for Adverse Events))
研究者
Archana mishra
Department of ENT