Study on the Effect of Electroacupuncture at Both Zusanli and at Both Yanglingquan Acupoints on Cardiovascular Activity
This study is currently recruiting participants.
Verified August 2012 by China Medical University Hospital
Sponsor:
China Medical University Hospital
Information provided by (Responsible Party):
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01665105
First received: July 20, 2012
Last updated: August 13, 2012
Last verified: August 2012
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Purpose
The purpose of this present study was to investigate the effect of electroacupuncture at both Zusanli and at both Yanglingquan acupoints on autonomic nerve modulating cardiovascular activity, and skin blood flow and skin temperature. The investigators use pulse rate variability to investigate autonomic nerve modulates cardiovascular function, and using distant skin blood flow and skin temperature recordings to investigate the relationship between the same names meridian of hand and foot.
| Condition | Intervention |
|---|---|
|
Reaction of Autonomic Nervous System Reaction of Acupuncture Reaction of Blood Circulation |
Device: acupuncture |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Study on the Effect of Electroacupuncture at Both Zusanli and at Both Yanglingquan Acupoints on Autonomic Nerve Modulating Cardiovascular Activity , and Skin Blood Flow and Skin Temperature |
Resource links provided by NLM:
Further study details as provided by China Medical University Hospital:
Primary Outcome Measures:
- From pulse wave, pulse rate variability and skin blood flow to measure cardiovascular activities with electroacupuncture at Zusanli and at Yanglingquan. [ Time Frame: each period was 20 min in duration. The parameters of pulse wave, 5-min pulse rate variability were recorded at the end of each period. ] [ Designated as safety issue: No ]Each session was divided into three periods of before electroacupuncture, electroacupuncture, and post electroacupuncture. Each period was 20 min in duration. During each period, the final 5 min of the period was pulse rate variability recordings of left hand by ANSWatch(TS-0411 model). This data were storage as primary outcomes and analyzed in a personal computer.
Secondary Outcome Measures:
- From skin blood flow and skin temperature to measure cardiovascular activities with electroacupuncture at Zusanli and at Yanglingquan. [ Time Frame: each period was 20 min in duration. The parameters of skin blood flow and skin temperature were recorded at the end of each period. ] [ Designated as safety issue: No ]Each session was divided into three periods of before electroacupuncture, electroacupuncture, and post electroacupuncture. Each period was 20 min in duration. During each period, the ahead 15 min of the period was the skin blood flow and skin temperature recordings at Hoku's and Zhongzhu's region of right hand by Laser doppler blood flow monitor (Moor instruments DRT4 model). This data were storage as seconrdary outcomes and analyzed in a personal computer.
| Estimated Enrollment: | 24 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Zusanli Group
electroacupuncture at both Zusanli on the leg, and record simultaneously the pulse rate variability as well as take the skin blood flow and skin temperature recordings at Hoku's and Zhongzhu's region of right hand.
|
Device: acupuncture
electroacupuncture at at Zusanli, electroacupuncture at Yanglingquan, and acupuncture at non-acupoint.
|
|
Active Comparator: Yanlingquan Group
electroacupuncture at both Yanglingquan on the leg, and record simultaneously the pulse rate variability as well as take the skin blood flow and skin temperature recordings at Hoku's and Zhongzhu's region of right hand.
|
Device: acupuncture
electroacupuncture at at Zusanli, electroacupuncture at Yanglingquan, and acupuncture at non-acupoint.
|
|
Sham Comparator: Sham Group
acupuncture without electrical stimulation at non-acupoint on the leg, and record simultaneously pulse rate variability as well as take the skin blood flow and skin temperature recordings at Hoku's and Zhongzhu's region of right hand.
|
Device: acupuncture
electroacupuncture at at Zusanli, electroacupuncture at Yanglingquan, and acupuncture at non-acupoint.
|
Detailed Description:
A total of 24 adult healthy volunteer were studied, they received the three sessions of sham electroacupuncture, electroacupuncture at Zusanli and electroacupuncture at Yanglingquan, respectively. Each session was divided into three periods of before electroacupuncture, electroacupuncture, and post electroacupuncture. Each period was 20 min in duration. The ahead 15 min of the period was the skin blood flow and skin temperature recordings at Hoku's and Zhongzhu's region of right hand; the final 5 min of the period was pulse rate variability recordings of left hand. The data was storage and analysis in a personal computer.
Eligibility| Ages Eligible for Study: | 20 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- healthy volunteers without without cardiac disease, taking medications, smoking
- before experiment, abstaining from caffeine, alcohol for 8 hours.
- age between 20-40.
Exclusion Criteria:
- volunteers with cardiac disease, taking medications, smoking
- age greater than 40 or less than 20.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665105
Contacts
| Contact: Ching-Liang Hsieh, professor | 886-4-22052121 ext 5024 | clhsieh@mail.cmuh.org.tw |
Locations
| Taiwan | |
| China Medical University Hospital | Recruiting |
| Taichung City, Taiwan, 40447 | |
| Contact: Ching-Liang Hsieh, professor 886-4-22052121 ext 5024 clhsieh@mail.cmuh.org.tw | |
| Sub-Investigator: Shih-Yi Wu, postgraduate | |
Sponsors and Collaborators
China Medical University Hospital
Investigators
| Principal Investigator: | Ching-Liang Hsieh, professor | China Medical University Hospital |
More Information
No publications provided
| Responsible Party: | China Medical University Hospital |
| ClinicalTrials.gov Identifier: | NCT01665105 History of Changes |
| Other Study ID Numbers: | DMR101-IRB2-101 |
| Study First Received: | July 20, 2012 |
| Last Updated: | August 13, 2012 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by China Medical University Hospital:
|
Pulse Rate Variability Skin Blood Flow Skin Temperature |
Electroacupuncture Zusanli Yanglingquan |
ClinicalTrials.gov processed this record on May 23, 2013