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临床试验/NCT02255006
NCT02255006Unknown不适用

Effect of Acupuncture to Endothelial Dysfunction Induced by Ischemia-reperfusion Injury Via Adenosine Triphosphate-sensitive Potassium Channels or Prostaglandin Pathway

Kyunghee University Medical Center1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Experimental

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

Experimental

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

Sham Comparator

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

Experimental

Glibenclamide (Euglucon, Roche Pharma) is administered 3 hours before FMD measurement.

干预措施: Active acupuncture (Device)

Euglycon

Experimental

Glibenclamide (Euglucon, Roche Pharma) is administered 3 hours before FMD measurement.

干预措施: Euglucon 5mg (Drug)

Celebrex

Experimental

Celebrex(celecoxib, pfizer) 200mg twice daily is administered for 5 days before FMD measurement.

干预措施: Active acupuncture (Device)

Celebrex

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Weon Kim

Professor

Kyunghee University Medical Center

研究点 (1)

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