CTRI/2023/10/058825招募中Unknown
Adjuvant potential of metformin with standard AEDs in persons with active epilepsy: a Randomised controlled trial - NI
Ratnav Singh0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1) Clinically diagnosed persons with active epilepsy (PWE) with at least 2 seizures in the past 3 months and on a stable AEDs treatment regimen for last one month.
- •2) Either male or female subject of 18 to 60 years old age 3) Pharmacoresistance to at least one tolerated and appropriately chosen and used AED schedules to achieve
- •sustained seizure freedom.
- •4) Patient ready to give informed consent
- •5) Ability to maintain seizure diary
排除标准
- •1) Pregnant or seeking pregnancy and nursing mother
- •2) Patient undergoing AED tapering
- •3) Patient with active liver disease or persistent liver dysfunction, gallstones or biliary disease
- •4) Patient with severe renal impairment (eGFR <45ml/min/1.73m 2) or undergoing dialysis
- •5) Patient with known cardiac diseases including heart failure, severe pulmonary disease, chronic alcoholism, sepsis, severe vitamin B12 deficiency.
- •6) Patienton any other drugs known to alter seizure threshold or cause interactions with AEDs (e.g. isoniazid,
- •theophylline, metronidazole, fluoxetine, fluvoxamine, clarithromycin, erythromycin, fluconazole, etc.) or
- •with metformin (e.g. cimetidine, nifedipine, furosemide etc.)
- •7) Patient already on metformin therapy for the past 3 months or with a known hypersensitivity to
- •8) Poor compliance with AEDs
研究者
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