Reaction of Autonomic Nervous SystemNCT01339715
The Difference Between Acupuncture and Far-infrared Ray Illumination at CV12 Acupoint
A study testing acupuncture and far-infrared ray in people with Reaction of Autonomic Nervous System and Reaction of Acupuncture, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Reaction of Autonomic Nervous System, Reaction of Acupuncture, Reaction of Far Infrared Ray
- What is being tested?
- acupuncture and far-infrared ray
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: From the Changes of Ryodoraku Value at 12 Source Acupoints, and Heart Rate Viability to Explain the Difference Between Acupuncture and Far-infrared Ray Illumination at CV12（Zhongwan）Acupoint
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.
Read the 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.
- Conditions
- Reaction of Autonomic Nervous System, Reaction of Acupuncture, Reaction of Far Infrared Ray
- Being tested
- acupuncture and far-infrared ray
- Keywords
- Ryodoraku, Heart Rate Variability, Traditional medicine, Autonomic Nervous System, Acupuncture, Far Infrared Ray, CV12 Acupoint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture and far-infrared rayProcedure or surgery
During experimental phase,inserting the needle of acupuncture into CV12 acupoint or using far-infrared ray to illuminate on CV12 20 minutes.
What is being measured
The primary outcome is the main question the study is designed to answer.
From the changes of Ryodoraku value at 12 source acupoints, and heart rate viability to measure the difference
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reaction of Autonomic Nervous SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ching-Liang Hsieh, professor, Study chair, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339715
- Sponsor's protocol ID
- DMR100-IRB-032
- Status last verified
- Jul 2012
- First submitted
- 17 Apr 2011
- Last updated
- 23 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From the Changes of Ryodoraku Value at 12 Source Acupoints, and Heart Rate Viability to Explain the Difference Between Acupuncture and Far-infrared Ray Illumination at CV12（Zhongwan）Acupoint
- ClinicalTrials.gov ID
- NCT01339715
- Acronym / sponsor ID
- DMR100-IRB-032
- Conditions
- Reaction of Autonomic Nervous System, Reaction of Acupuncture, Reaction of Far Infrared Ray
- Keywords
- Ryodoraku, Heart Rate Variability, Traditional medicine, Autonomic Nervous System, Acupuncture, Far Infrared Ray, CV12 Acupoint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 21 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupuncture and far-infrared rayDuring experimental phase,inserting the needle of acupuncture into CV12 acupoint or using far-infrared ray to illuminate on CV12 20 minutes. | Procedure or surgery | – |
Primary outcome
From the changes of Ryodoraku value at 12 source acupoints, and heart rate viability to measure the difference
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ching-Liang Hsieh, professor study chair
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture and far-infrared ray in people with Reaction of Autonomic Nervous System and Reaction of Acupuncture, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
From the changes of Ryodoraku value at 12 source acupoints, and heart rate viability to measure the difference (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2012.