CTRI/2018/07/014797尚未招募Unknown
A prospective, open-label, non-comparative study to assess the efficacy and safety of Betahistine in patients with Acute Peripheral Vertigo
Dr Carlton Pereira1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年7月16日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To establish the efficacy of betahistine in treatment naïve acute peripheral vertigo patients
研究概览
简要总结
The study is a prospective, open-label, non-comparative toassess the effectiveness and safety of Betahistine in patients with Acute PeripheralVertigo. Eligible patients will receive the study drug at the baseline visit. Subjects will be monitored throughout the study duration for adverse events, drug to drug interactions.The subject will be in the study for 21 days and subjects are assessed for effectiveness of the treatment during their visits using certain assessment scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female aged ≥18 years 2.Patients with confirmed peripheral vertigo based on clinical diagnosis 3.Patients naïve to treatment for peripheral vertigo.
排除标准
- •1.Patients with middle or inner ear infection, who required surgery 2.Patients suffering from brain tumor, head trauma, epilepsy, multiple sclerosis and paralysis of eye muscles 3.Patient with established psychiatric disorders, significant neurological disorder like Parkinson’s disease or spinal cord damage.
- •4.Pregnant and lactating women 5.Patients with peptic ulcer 6.Patients with pheochromocytoma 7.Patients with bronchial asthma 8.Patients receiving any other agents for peripheral vertigo such as diuretics, transtympanic gentamycin, cinnarizine, and H1 antagonists (dimenhydrinate, promethazine, diphenhydramine etc.) 9.Patients who are regular users of excessive amount of drugs and alcohol 10.Patients with known hypersensitivity/allergic reaction to Betahistine 11.Participants in any clinical trial in past 30 days before enrollment.
结局指标
主要结局
To establish the efficacy of betahistine in treatment naïve acute peripheral vertigo patients
时间窗: During Treatment period/Study duration.
次要结局
- 1 To evaluate the effect of betahistine on frequency and severity of peripheral vertigo using VNG test.(2 To evaluate the effect of betahistine on severity of peripheral vertigo using DHI and SVVSLCRE scales.)
研究者
研究点 (1)
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