Metformin Efficacy and Safety in Epileptic Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Seizures Frequency
研究概览
简要总结
The goal of this clinical trial is to Evaluating Metformin Efficacy and Safety when Co-administered with Antiepileptic Drugs in Patients with Seizures. The main question it aims to answer is:
- Does metformin have beneficial effect on epileptic patients?
- How metformin can affect epileptic patient's health?
Participants will be divided into 2 groups (control group and treatment group)
- Control group will receive standard treatment (levetiracetam &/or sodium valproate).
- Treatment group will receive standard treatment (levetiracetam &/or sodium valproate) + metformin
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 - 65 years old
- •Obese and overweight patients with body mass index (BMI) ≥
- •Diabetic & non diabetic patients.
排除标准
- •Patients with severe liver damage or kidney disease (eGFR below 45mL/min/1.73 m²).
- •Patients having acute or chronic disease which may cause tissue hypoxia and increase the risk of lactic acidosis (e.g. cardiac/respiratory failure, recent myocardial infarction).
- •Patients who are already taking metformin.
- •Cancer patients.
- •Pregnant or lactating women.
- •Patients with known hypersensitivity to the drug.
研究组 & 干预措施
Control group (+ve control)
levetiracetam &/or sodium valproate
干预措施: Levetiracetam &/or sodium valproate (Drug)
Treatment group
metformin + (levetiracetam &/or sodium valproate)
干预措施: Levetiracetam &/or sodium valproate (Drug)
Treatment group
metformin + (levetiracetam &/or sodium valproate)
干预措施: Metformin (Drug)
结局指标
主要结局
Seizures Frequency
时间窗: 6 months
will be recorded using seizures diary.
Quality of Life level
时间窗: 6 months
will be recorded using SF-36 health survey.
Seizures Severity
时间窗: 6 months
will be measured using chalfont seizures severity scale.
次要结局
- Change in BMI(6 months)
- Change in biological markers(6 months)
研究者
Omnia Ashraf Abd El Aziz Ahmed
Teacher Assisstant
Tanta University