Randomized Double Blind Controlled Trial on Sulodexide Efficacy in Chronic Idiopathic Subjective Tinnitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Tinnitus Handicap Inventory (THI)
研究概览
简要总结
The objective of this prospective randomized and double blind controlled study is to evaluate the efficacy and safety of Sulodexide (25 mg) in the treatment of chronic idiopathic subjective tinnitus.
详细描述
Patients with chronic idiopathic subjective tinnitus, since at least 1 year, re recruited from our Ear, Nose and Throat (ENT) clinic. After verification of inclusion and exclusion criteria, patients consenting to enter the study are assigned randomly to one of the following groups: 1- Sulodexide 25 mg for 40 days 2- Placebo for 40 days. Clinical evaluation of the patient is performed; tinnitus is assessed according to Tinnitus Handicap Inventory score, Mini Tinnitus Questionnaire score. Adverse effects are also noted. Patients are followed at 40 days post-treatment and outcome measures are assessed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tinnitus for minimum of 1 year
- •Absence of psychiatric or neurological diseases
- •Absence of any disease that explains tinnitus
- •Noise-induced hearing loss
- •Cochlear and retro-cochlear damage
排除标准
- •Conductive hearing loss
- •Mixed hearing loss
- •Meniere's disease
- •Systemic vascular disease
- •Diabetic disease
- •Vestibular schwannoma
- •Cerebello-pontine angle tumors
- •Pulsatile tinnitus
- •Pregnancy
研究组 & 干预措施
Sulodexide
Sulodexide 25 mg twice per day for 40 days
干预措施: Sulodexide (Drug)
Placebo
1 tablet twice per day for 40 days
干预措施: Placebo (Drug)
结局指标
主要结局
Tinnitus Handicap Inventory (THI)
时间窗: At day 0 and at 40 days
Assessment of changes in THI questionnaire score between Day 40 and 0
次要结局
- Mini Tinnitus Questionnaire (Mini-TQ)(At day 0 and at 40 days)
- Adverse effects(Up to 40 days)
研究者
Dr Joseph Maarrawi
Head of the Laboratory of Neurosciences
St Joseph University, Beirut, Lebanon