<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01665105</url>
  </required_header>
  <id_info>
    <org_study_id>DMR101-IRB2-101</org_study_id>
    <nct_id>NCT01665105</nct_id>
  </id_info>
  <brief_title>Study on the Effect of Electroacupuncture at Both Zusanli and at Both Yanglingquan Acupoints on Cardiovascular Activity</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Medical University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China Medical University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this present study was to investigate the effect of electroacupuncture at both&#xD;
      Zusanli and at both Yanglingquan acupoints on autonomic nerve modulating cardiovascular&#xD;
      activity, and skin blood flow and skin temperature. The investigators use pulse rate&#xD;
      variability to investigate autonomic nerve modulates cardiovascular function, and using&#xD;
      distant skin blood flow and skin temperature recordings to investigate the relationship&#xD;
      between the same names meridian of hand and foot.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 24 adult healthy volunteer were studied, they received the three sessions of sham&#xD;
      electroacupuncture, electroacupuncture at Zusanli and electroacupuncture at Yanglingquan,&#xD;
      respectively. Each session was divided into three periods of before electroacupuncture,&#xD;
      electroacupuncture, and post electroacupuncture. Each period was 20 min in duration. The&#xD;
      ahead 15 min of the period was the skin blood flow and skin temperature recordings at Hoku's&#xD;
      and Zhongzhu's region of right hand; the final 5 min of the period was pulse rate variability&#xD;
      recordings of left hand. The data was storage and analysis in a personal computer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>From pulse wave, pulse rate variability and skin blood flow to measure cardiovascular activities with electroacupuncture at Zusanli and at Yanglingquan.</measure>
    <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.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>From skin blood flow and skin temperature to measure cardiovascular activities with electroacupuncture at Zusanli and at Yanglingquan.</measure>
    <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.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Reaction of Autonomic Nervous System</condition>
  <condition>Reaction of Acupuncture</condition>
  <condition>Reaction of Blood Circulation</condition>
  <arm_group>
    <arm_group_label>Zusanli Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Yanlingquan Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>acupuncture</intervention_name>
    <description>electroacupuncture at at Zusanli, electroacupuncture at Yanglingquan, and acupuncture at non-acupoint.</description>
    <arm_group_label>Sham Group</arm_group_label>
    <arm_group_label>Yanlingquan Group</arm_group_label>
    <arm_group_label>Zusanli Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. healthy volunteers without without cardiac disease, taking medications, smoking&#xD;
&#xD;
          2. before experiment, abstaining from caffeine, alcohol for 8 hours.&#xD;
&#xD;
          3. age between 20-40.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. volunteers with cardiac disease, taking medications, smoking&#xD;
&#xD;
          2. age greater than 40 or less than 20.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ching-Liang Hsieh, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>China Medical University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung City</city>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>July 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>July 11, 2013</last_update_submitted>
  <last_update_submitted_qc>July 11, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 12, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pulse Rate Variability</keyword>
  <keyword>Skin Blood Flow</keyword>
  <keyword>Skin Temperature</keyword>
  <keyword>Electroacupuncture</keyword>
  <keyword>Zusanli</keyword>
  <keyword>Yanglingquan</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01665105
org study id: DMR101-IRB2-101
nct id: NCT01665105
lead sponsor: 
has dmc: No
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.
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.
allocation: Non-Randomized
intervention model: Factorial Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: 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.
description: 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.
measure: 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.
description: 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.
arm group label: Zusanli Group
arm group type: Experimental
description: 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.
arm group label: Yanlingquan Group
arm group type: Active Comparator
description: 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.
arm group label: Sham Group
arm group type: Sham Comparator
description: 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.
intervention type: Device
intervention name: acupuncture
description: electroacupuncture at at Zusanli, electroacupuncture at Yanglingquan, and acupuncture at non-acupoint.
arm group label: Sham Group
arm group label: Yanlingquan Group
arm group label: Zusanli Group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ching-Liang Hsieh, professor
role: Principal Investigator
affiliation: China Medical University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor