Effects of myoinositol supplementation on seizure frequency in person with drug resistant epilepsy:A double blind randomized N-of-1 trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- To find out the percentage change in seizure frequency after every month for the six months with alternating monthly treatment cycle of myoinositol or placebo drug resistant epilepsy patients.
研究概览
简要总结
This study is being conducted to asses the percentage change in seizure frequency in drug resistant epilepsy patients after alternative therapy of myoinositol/palcebo every month and to find effect of myoinositol on various biomarker in epilpetogenesis such as EEG evaluation ,HMIT cotransporter, PI3k biomarker , IGF-1 biomarker. To find out the effect of myoinositol in epilepsy.To find out the safety of myoinositol intervention through monthly assessment of safety monitoring (ADR assessment ,Liverpool Adverse event profile ,DASS-21,BPAQ and quality of life index in epilepsy (QOLIE-10),seizure severity scale,duration of days with seizure freedom, liver and renal function test.Randomisation was done based on age,sex,seizure frequency, type of epilepsy.All patients are counselled for life style, including diet, not to change the regular diet habit during whole double blind study period. subjects are asked to avoid alcohol and smoking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Clinically diagnosed persons with drug resistant epilepsy
- •Either gender 18-45 year 3.Able to maintain seizure diary 4.Subjects with diagnosis of pre diabetics or PCOS.
排除标准
- •Any other neurological disease 2.Status epileptics within 3 months prior to enrollment or during treatment period 3.Person with kidney failure.
结局指标
主要结局
To find out the percentage change in seizure frequency after every month for the six months with alternating monthly treatment cycle of myoinositol or placebo drug resistant epilepsy patients.
时间窗: Six months
次要结局
- A.To find out the effect of myoinositol on epileptogenesis by estimation of various biomarker such as:(1.EEG evaluation)
研究者
Dr Saket Yadav
All India Institute of Medical Sciences ,New Delhi