An interventional study of Active acupuncture and Sham acupuncture in Healthy, sponsored by Kyunghee University Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 25 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-02.
Sponsored by Kyunghee University Medical Center · Not applicable, Interventional, and Treatment
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.
271 studies on the registry are indexed under Reperfusion Injury; 42 are open to participants now.
This study's planned enrollment of 36 is below the median of 61 across 215 interventional studies indexed under Reperfusion Injury.
Browse Reperfusion Injury studies →Kyunghee University Medical Center is the lead sponsor of 62 studies on the registry; 5 are open to participants now.
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The participants in this group receive real acupuncture treatment at first. Afterwards crossover study is scheduled to be performed.
Device: Active acupuncture · Drug: Euglucon 5mg · Drug: Celebrex 200mg
The participants in this group receive sham acupuncture treatment at first. afterwards crossover study is scheduled to be performed
Device: Sham acupuncture
Glibenclamide (Euglucon, Roche Pharma) is administered 3 hours before FMD measurement.
Device: Active acupuncture · Drug: Euglucon 5mg
Celebrex(celecoxib, pfizer) 200mg twice daily is administered for 5 days before FMD measurement.
Device: Active acupuncture · Drug: Celebrex 200mg
Active acupuncture treatment group receive electroacupuncture (EA). For EA treatment, unilateral acupuncture meridian point Pericardium5 (PC5), Pericardium6 (PC6), Stomach36 (ST36), and Stomach37 (ST37) are chosen. Disposable, sterile needles and low frequency electrical stimulator (ES-160, ITO, Japan) are used. Each needle is inserted to the depth of 2cm with a 90 degree angle. Thereafter, needles are connected with the pole and electrical stimulation is applied with 2 Hertz continuous wave current. After FMD measurement, a pneumatic cuff placed above the upper arms is inflated to 200 mmHg for 15 minutes. The cuff is then deflated, and 15 minutes of reperfusion is allowed before FMD measurement again. Acupuncture is performed from after ten minutes of ischemia till end time of reperfusion
For sham intervention, nonacupuncture points are used. Electrical acupuncture is connected but electrical stimulation is not given to sham acupuncture group. Volunteers undergo FMD measurement and acupuncture like above methods.
8 healthy volunteers are administered 5 mg of glibenclamide (Euglucon, Roche Pharma) 3 hour before FMD measurement. This dosage has previously been shown to be able to completely inhibit forearm KATP channels. With the glibenclamide administration, a 10% dextrose infusion is started and titrated to maintain blood sugar levels between 80 and 120 mg/dL throughout the study period. 3 hours after glibenclamide administration, the subjects undergo FMD measurement before and after ischemia reperfusion injury. During ischemia reperfusion period, active acupuncture treatment is performed for 20 minutes like above method.
Also known as: Glibenclamide
8 healthy volunteers are administered celecoxib, a selective COX-2 inhibitor, 200 mg twice daily for 5 days. Last dose of celecoxib is administered at morning. Volunteers undergo FMD measurements before and after ischemia reperfusion injury in that morning of last dose of celecoxib. During ischemia reperfusion period, active acupuncture treatment is performed for 20 minutes like above method
Also known as: Celecoxib
The difference of endothelial function
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
Time frame: 4 week
The difference of endothelial function
Endothelial function is also measured by brachial flow mediated dilation (FMD). Is the difference of endothelial function mediated by acupuncture hampered by Triphosphate-Sensitive Potassium (KATP) Channels inhibitor glibenclamide or selective cox-2 inhibitor celebrex if acupuncture could improve flow mediated dilation after ischemia reperfusion injury? It is performed for knowing which mechanisms are involved in this improvement if acupuncture could improve flow mediated dilation after ischemia reperfusion injury?
Time frame: 4 week
This study is status unknown, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Kyunghee University Medical Center