A Randomized, Double-Blind, Placebo-Controlled Trial of Coenzyme Q10 as Adjunctive Therapy in Patients With Drug-Resistant Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Change in seizure frequency (seizures per month)
研究概览
简要总结
This study evaluates the efficacy and safety of coenzyme Q10 supplementation as adjunctive therapy in patients with drug-resistant epilepsy.
详细描述
This randomized, double-blind, placebo-controlled trial investigates coenzyme Q10 supplementation as adjunctive therapy in patients with drug-resistant epilepsy.
Eligible participants will be randomly assigned to receive either coenzyme Q10 or matching placebo in addition to their stable baseline anti-seizure medications. Coenzyme Q10 will be administered orally at a dose of 200 mg per day for 12 weeks.
Participants will be followed prospectively with scheduled clinical assessments throughout the study period to evaluate treatment response and safety.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, care providers, investigators, and outcomes assessors are blinded to group assignment. Placebo capsules are identical in appearance to coenzyme Q10 to maintain blinding.
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 20 to 80 years.
- •Diagnosed with drug-resistant epilepsy.
- •Receiving stable anti-seizure medications for at least 4 weeks prior to enrollment.
- •Able to provide informed consent.
- •Willing and able to maintain seizure diaries throughout the study period.
排除标准
- •History of progressive neurological disease.
- •Severe systemic illness (e.g., uncontrolled cardiovascular, hepatic, or renal disease).
- •Use of coenzyme Q10 or other mitochondrial supplements within 4 weeks prior to enrollment.
- •Pregnancy or breastfeeding.
- •Known allergy or hypersensitivity to coenzyme Q
- •Participation in another clinical trial within the past 3 months.
研究组 & 干预措施
Placebo
Matching placebo capsules administered orally once daily for 12 weeks.
干预措施: Placebo (Dietary Supplement)
Coenzyme Q10
Participants in this arm received oral coenzyme Q10 supplementation at a dose of 200 mg per day in addition to their stable baseline anti-seizure medications. The supplementation was administered daily for 12 weeks.
干预措施: coenzyme Q10 (Dietary Supplement)
结局指标
主要结局
Change in seizure frequency (seizures per month)
时间窗: Baseline and 12 weeks
Seizure frequency will be assessed using patient seizure diaries. The number of seizures per month will be calculated and compared between baseline and 12 weeks.
次要结局
- Change in cognitive function assessed by the Cognitive Abilities Screening Instrument (CASI; score range 0-100, higher scores indicate better cognitive function)(Baseline and 12 weeks)