Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study on the Effect of Electroacupuncture at Both Zusanli and at Both Yanglingquan Acupoints on Cardiovascular Activity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01665105
First received: July 20, 2012
Last updated: July 11, 2013
Last verified: July 2013
  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: Single Blind (Subject)
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.


Enrollment: 24
Study Start Date: July 2012
Study Completion Date: May 2013
Primary Completion Date: November 2012 (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:

  1. healthy volunteers without without cardiac disease, taking medications, smoking
  2. before experiment, abstaining from caffeine, alcohol for 8 hours.
  3. age between 20-40.

Exclusion Criteria:

  1. volunteers with cardiac disease, taking medications, smoking
  2. age greater than 40 or less than 20.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665105

Locations
Taiwan
China Medical University Hospital
Taichung City, Taiwan, 40447
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: July 11, 2013
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 November 20, 2014