The Effect of α-lipoic Acid Treatment in Patient With Cardiac Autonomic Neuropathy by Comparing the Change of HRV Index & ANS Function:A 6month Multicenter, Randomized, Open Label Clinical Trial CANON Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 3
- 主要终点
- Primary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy
研究概览
简要总结
The purpose of this study is to see if it is safe and effective to give alpha lipoic acid in people with cardiac autonomic neuropathy(CAN). Cardiac autonomic neuropathy(CAN) affects the nerves that control heart rate and blood flow to the heart in people with diabetes. CAN may cause problems with the rhythm of the heartbeat or decrease blood flow to the heart.
详细描述
Study type : Interventional Study Design : Allocation: Randomized Control: no treatment Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment Primary Outcome Measures : Heart rate variability(HRV) Index
Secondary Outcome Measures : Autonomic Nerve System(ANS) function 5 test, EuroQoL 5-Dimension Questionnaire(EQ-5D)
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
α-lipoic acid
α-lipoic acid PO medication, 600mg per day, for 6weeks α-lipoic acid PO medication, 1200mg per day, for 6weeks
干预措施: α-lipoic acid (Drug)
结局指标
主要结局
Primary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy
时间窗: up to 24weeks
check the Heart rate variability(HRV) Index
次要结局
- Secondary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy(up to 24weeks)
研究者
Chong Hwa Kim
Professor
The Catholic University of Korea