Intratympanic dexamethasone injection versus Intratympanic Methylprednisolone for treatment of sudden sensorineural hearing loss : A Randomised controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- To assess the therapeutic effectiveness of a intratympanic dexamethasone as compared to
研究概览
简要总结
In this study, we will compare the therapeutic effectiveness of a intratympanic dexamethasone as compared to intratympanic methylprednisolone and the behavior of the different audiometric curves in response to both steroid therapies.
Patients presenting with sudden sensorineural hearing loss to the Department of ENT, Head and Neck Surgery at Government Multi Specialty Hospital, Chandigarh will be subjected to routine tests.
Patients will be randomly assigned into 2 groups based on their enrolment number. Even number patients will be in group I and odd number patient will be in group 2. Those in group I will be treated with 3 doses of 0.4 ml Intratympanic injections of Dexamethasone (4mg/ml); on alternate days and those in group 2 will receive 3 doses of 0.4 ml intratympanic methylprednisolone (40mg/ml). PTA will be repeated at 2 weeks, 4 weeks and 8 weeks from the first dose.
In the present study we will be comparing effectiveness of intratympanic dexamethasone and intratympanic methylprednisolone in the treatment of sudden sensorineural hearing loss as it creates a significant impact on the life of the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Individuals aged 18 years or older with sudden sensorineural hearing loss as determined by history & confirmed by audiometry.
- •2.Patients presenting within 2 weeks of onset of hearing loss.
排除标准
- •1.Patients who do not consent to participate in the study.
- •2.Patients with middle ear tumours and diseases.
- •3.Patients with viral infections.
- •4.Patients with hearing loss of more than 2 weeks duration.
- •5.Patients who have previously been treated for the same complaint.
- •6.Patients on ototoxic medication.
- •8.Patients with organic disorders such as Type 2 Diabetes Mellitus (T2DM), Chronic Renal Failure (CRF), tuberculosis, peptic ulcers, and glaucoma.
结局指标
主要结局
To assess the therapeutic effectiveness of a intratympanic dexamethasone as compared to
时间窗: To evaluate hearing by PTA at 2, 4 and 8 weeks
intratympanic methylprednisolone To evaluate the frequency specific improvement in both group of patients on steroid
时间窗: To evaluate hearing by PTA at 2, 4 and 8 weeks
therapies
时间窗: To evaluate hearing by PTA at 2, 4 and 8 weeks
次要结局
- To evaluate the side effects of both drugs in respective groups of patients.(To evaluate side effects)
研究者
Dr Kanika
Government Multi Specialty Hospital