Effect of Acupuncture to Endothelial Dysfunction Induced by Ischemia-reperfusion Injury (AURORAS)

Kyung Hee University

Status: Unknown

Conditions: Healthy

Treatments: Drug: Euglucon 5mg; Drug: Celebrex 200mg; Device: Active acupuncture; Device: Sham acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02255006

HI13C0580-2

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 25 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy volunteer age 25 to 40 years
• non-smoker

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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36 participants in 4 patient groups

active acupuncture

Experimental group

Description:

The participants in this group receive real acupuncture treatment at first. Afterwards crossover study is scheduled to be performed.

Treatment:

Device: Active acupuncture

Drug: Celebrex 200mg

Drug: Euglucon 5mg

Sham acupuncture

Sham Comparator group

Description:

The participants in this group receive sham acupuncture treatment at first. afterwards crossover study is scheduled to be performed

Treatment:

Device: Sham acupuncture

Euglycon

Experimental group

Description:

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

Treatment:

Device: Active acupuncture

Drug: Euglucon 5mg

Celebrex

Experimental group

Description:

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

Treatment:

Device: Active acupuncture

Drug: Celebrex 200mg