The Difference Between Acupuncture and Far-infrared Ray I... | NCT01339715

Studies
The Difference Between Acupuncture and Far-infrared Ray Illumination at CV12 Acupoint

NCT01339715

Sponsor

China Medical University Hospital

Status

Completed

Last Update Posted

Jul 23, 2012Estimated

Enrollment

25Actual

Phase

Not Applicable

Conditions

Reaction of Autonomic Nervous System
Reaction of Acupuncture
Reaction of Far Infrared Ray

Interventions

acupuncture and far-infrared ray

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Mar 2012Actual

Completion Date

Mar 2012Actual

First Submitted Date

Apr 17, 2011

First Submission Date that Met QC Criteria

Apr 20, 2011

First Posted Date

Apr 21, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2012

Last Update Posted Date

Jul 23, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Acupuncture and far-infrared ray illumination at CV12 acupoint have been widely used to treat many diseases in clinic. To our knowledge, the report is about the different reaction on autonomic nervous system between acupuncture and far-infrared illumination is very rare until now.Therefore,the study was to investigate the different changes on autonomic nervous system from Ryodoraku value at 12 source acupoints and heart rate viability (HRV) when acupuncture or far-infrared ray illumination applied to CV12 acupoint.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
acupuncture and far-infrared ray	Procedure	During experimental phase,inserting the needle of acupuncture into CV12 acupoint or using far-infrared ray to illuminate on CV12 20 minutes.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ching-Liang Hsieh, professor	China Medical University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
China Medical University Hospital		Taichung		404	Taiwan

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics