NCT01665105

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2012

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 15, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

July 12, 2013

Status Verified

July 1, 2013

Enrollment Period

4 months

First QC Date

July 20, 2012

Last Update Submit

July 11, 2013

Conditions

Keywords

Pulse Rate VariabilitySkin Blood FlowSkin TemperatureElectroacupunctureZusanliYanglingquan

Outcome Measures

Primary Outcomes (1)

  • From pulse wave, pulse rate variability and skin blood flow to measure cardiovascular activities with electroacupuncture at Zusanli and at Yanglingquan.

    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 Outcomes (1)

  • From skin blood flow and skin temperature to measure cardiovascular activities with electroacupuncture at Zusanli and at Yanglingquan.

    each period was 20 min in duration. The parameters of skin blood flow and skin temperature were recorded at the end of each period.

Study Arms (3)

Zusanli Group

EXPERIMENTAL

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

Yanlingquan Group

ACTIVE COMPARATOR

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

Sham Group

SHAM COMPARATOR

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

Interventions

electroacupuncture at at Zusanli, electroacupuncture at Yanglingquan, and acupuncture at non-acupoint.

Sham GroupYanlingquan GroupZusanli Group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • volunteers with cardiac disease, taking medications, smoking
  • age greater than 40 or less than 20.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 40447, Taiwan

Location

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Ching-Liang Hsieh, professor

    China Medical University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2012

First Posted

August 15, 2012

Study Start

July 1, 2012

Primary Completion

November 1, 2012

Study Completion

May 1, 2013

Last Updated

July 12, 2013

Record last verified: 2013-07

Locations