Effect of vitamin E as an add-on therapy on oxidative stress in patients with epilepsy- A randomized placebo controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- JIPMER
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- primary objectives
研究概览
简要总结
**1.**Epilepsy is one of the most common neurological disorders worldwide. With numerous treatment options the need for antiepileptics for a long term in many patients makes their quality of life distressing. One of the profound mechanisms is due to oxidative stress that plays a major role in development and progression of epileptogenesis. This can be combated by vitamin E an antioxidant Vitamin which shows effective reduction in seizure frequency and oxidative stress as evidenced from previous literature. The novelty of this study lies in the fact that Indian population has inherently high oxidative stress which is due to higher homocysteine levels in blood contributed by various genetic and dietary factors. This study uses this property of vitamin E to modify the course of disease in patients with epilepsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 59.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adult patients of age ≥18 to ≤60 years of either gender.
- •2.Patients on Monotherapy with sodium valproate, Phenytoin, carbamazepine for at least a period of 6 months.
- •3.Patients with uncontrolled seizure (defined as having a seizure episode at least one per year when maintained on an adequate trial of antiepileptics).
排除标准
- •Patients with other comorbidities like renal diseases and liver diseases
- •Patients already on treatment with Vitamin E.
- •Patients with structural brain diseases and space occupying lesions as diagnosed on appropriate imaging
- •Patients not willing to give written informed consent
- •Pregnant and lactating women.
结局指标
主要结局
primary objectives
时间窗: Antioxidant levels and oxidative stress markers will be assessed at baseline and every 2 months until the follow up period of 6months
1.To estimate the changes in antioxidant levels and oxidative stress markers in patients receiving vitamin E as add-on therapy and its impact on seizure free interval when compared with placebo
时间窗: Antioxidant levels and oxidative stress markers will be assessed at baseline and every 2 months until the follow up period of 6months
次要结局
- To assess the EEG changes between both groups(This will be done at baseline and at 6 months)