- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01665105
Study on the Effect of Electroacupuncture at Both Zusanli and at Both Yanglingquan Acupoints on Cardiovascular Activity
July 11, 2013 updated by: China Medical University Hospital
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taichung City, Taiwan, 40447
- China Medical University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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.
|
electroacupuncture at at Zusanli, electroacupuncture at Yanglingquan, and acupuncture at non-acupoint.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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.
|
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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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.
|
each period was 20 min in duration. The parameters of skin blood flow and skin temperature were recorded at the end of each period.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ching-Liang Hsieh, professor, China Medical University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
July 20, 2012
First Submitted That Met QC Criteria
August 13, 2012
First Posted (Estimate)
August 15, 2012
Study Record Updates
Last Update Posted (Estimate)
July 12, 2013
Last Update Submitted That Met QC Criteria
July 11, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DMR101-IRB2-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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