Role of vitamin E supplementation in treatment resistant epilepsy in children in the age group 1-12 years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To study effect of Vitamin E supplementation in the reduction of seizure episodes in treatment resistant epilepsy patients on antiepileptuc drugs
研究概览
简要总结
Vitamin E is a antioxidant , oxidative stress is important pathogen for epilepsy and many of anti epileptic drugs produces oxidative stress, so vitamin E can act here.
Here Vitamin E is supplementing to treatment resistant epilepsy in addition to anticoagulant drugs for 6 months , study the outcomes like reduction in seizure episodes, relation with antiepileptic drugs and also side effects of vitamin E if any. EEG will be recorded before and after study.
Study completed, concluded that Vitamin helpful in reducing the number seizure lasting more than 5 min ( impending status).
No significant change in number seizure , EEG changes , antiepileptic drugs after supplementing vitamin E to children with treatment resistant epilepsy
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 1-12 years Diagnosis of treatment resistant epilepsy A) Recieving any of at least two anti convulsant drugs for past 6 months B) at least 3 seizures in last 6 months C) the ability of family or friends to count the number of seizures in epileptic patients during the determined period.
排除标准
- •Neuroimaging suggestive of mass lesion Receiving vitamin E supplementation within 6 months of study Presence of live and kidney disease.
结局指标
主要结局
To study effect of Vitamin E supplementation in the reduction of seizure episodes in treatment resistant epilepsy patients on antiepileptuc drugs
时间窗: 6 months
次要结局
- To study seizure episode reduction in different types of seizure in Vitamin E supplemented children(To study correlation of vitamin E supplementation and reduction of seizure episodes with different antiepileptic drugs)