NCT01339715

Brief Summary

The purpose of the study was to investigate the changes of Ryodoraku value at 12 source acupoints, and heart rate viability (HRV) when acupuncture or far-infrared ray illumination applied to CV12 acupoint.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2011

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

April 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

July 23, 2012

Status Verified

July 1, 2012

Enrollment Period

11 months

First QC Date

April 17, 2011

Last Update Submit

July 20, 2012

Conditions

Keywords

RyodorakuHeart Rate VariabilityTraditional medicineAutonomic Nervous SystemAcupunctureFar Infrared RayCV12 Acupoint

Outcome Measures

Primary Outcomes (1)

  • From the changes of Ryodoraku value at 12 source acupoints, and heart rate viability to measure the difference

    Each period was 20 min in duration. The Ryodoraku value of 12 source acupoints were measured, and 5-min HRV was recorded at the end of each period.

Interventions

During experimental phase,inserting the needle of acupuncture into CV12 acupoint or using far-infrared ray to illuminate on CV12 20 minutes.

Eligibility Criteria

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

You may qualify if:

  • Healthy adult volunteers, male or female, ages between 20 and 40
  • Neurological and physical examination without abnormal functions
  • Far-infrared ray illumination without allergic reaction and contra- indication
  • The participants were explained the objective of the study, agreed to accept the test and signed a letter of consent

You may not qualify if:

  • People less than 20 years of age or more than 40 years
  • Women in pregnant or lactating
  • People with mental or behavioral anomalies could not follow the researchers
  • People with pacemakers
  • People suffered from serious diseases such as myocardial infarction , heart failure, serious arrhythmia, hypertension, diabetes, autoimmune disease, chronic obstructive pulmonary diseases, and kidney failure, liver cirrhosis and cancer
  • People accepted acupuncture and moxibustion in a week, or were taking any drugs for treatment
  • People suffered from limb edema and serious skin diseases
  • People with excessive obesity (body mass index, BMI\>30)
  • People did not sign a letter of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

Location

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Ching-Liang Hsieh, professor

    China Medical University Hospital

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

April 17, 2011

First Posted

April 21, 2011

Study Start

April 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

July 23, 2012

Record last verified: 2012-07

Locations