Effect of Acupuncture to Endothelial Dysfunction Induced by Ischemia-reperfusion Injury Via Adenosine Triphosphate-sensitive Potassium Channels or Prostaglandin Pathway
试验速览
- 阶段
- 不适用
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The difference of endothelial function
研究概览
简要总结
Some studies suggest that acupuncture improve flow mediated dilation (FMD) that represents endothelial function, but no study has investigated whether acupuncture protects against ischemia and reperfusion (IR)-induced endothelial dysfunction in humans.
This is a prospective crossover study clinical trial. In the first crossover study, 20 healthy nonsmoking volunteers (25 to 40 years old) will be randomly assigned to acupuncture or control. Endothelium-dependent, FMD of the brachial artery will be measured before and after IR (15 minutes of ischemia at the level of the proximal upper arm followed by 15 minutes of reperfusion). Acupuncture will be performed from 10 minute after ischemia till the end time of reperfusion for 20 minutes. In the second single arm study, 16 volunteers are administered oral 5mg glibenclamide two hours before IR injury (n=8) or selective cox-2 inhibitor celecoxib 200mg twice a day for 5 days to know what mechanism is responsible for acupuncture effect on IR injury. FMD measurements and acupuncture intervention during IR injury are same as above mentioned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 40 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteer age 25 to 40 years
- •non-smoker
排除标准
- •hypertension (>140/90 mmHg), diabetes any cardiovascular disease kidney disease thyroid disease cerebrovascular disease liver disease (bilirubin level >2 mg/dl) pregnancy body mass index >25 kg/m2
研究组 & 干预措施
active acupuncture
The participants in this group receive real acupuncture treatment at first. Afterwards crossover study is scheduled to be performed.
干预措施: Active acupuncture (Device)
active acupuncture
The participants in this group receive real acupuncture treatment at first. Afterwards crossover study is scheduled to be performed.
干预措施: Euglucon 5mg (Drug)
active acupuncture
The participants in this group receive real acupuncture treatment at first. Afterwards crossover study is scheduled to be performed.
干预措施: Celebrex 200mg (Drug)
Sham acupuncture
The participants in this group receive sham acupuncture treatment at first. afterwards crossover study is scheduled to be performed
干预措施: Sham acupuncture (Device)
Euglycon
Glibenclamide (Euglucon, Roche Pharma) is administered 3 hours before FMD measurement.
干预措施: Active acupuncture (Device)
Euglycon
Glibenclamide (Euglucon, Roche Pharma) is administered 3 hours before FMD measurement.
干预措施: Euglucon 5mg (Drug)
Celebrex
Celebrex(celecoxib, pfizer) 200mg twice daily is administered for 5 days before FMD measurement.
干预措施: Active acupuncture (Device)
Celebrex
Celebrex(celecoxib, pfizer) 200mg twice daily is administered for 5 days before FMD measurement.
干预措施: Celebrex 200mg (Drug)
结局指标
主要结局
The difference of endothelial function
时间窗: 4 week
Endothelial function is measured by brachial flow mediated dilation (FMD). Is there a difference of forearm FMD achieved following ischemia reperfusion injury between acupuncture and control group
次要结局
- The difference of endothelial function(4 week)
研究者
Weon Kim
Professor
Kyunghee University Medical Center
