HealthyNCT01564927
Physiological Changes Associated With Deqi During Electroacupuncture to Right LI4 and LI11
A study testing Electroacupuncture to right LI4 and LI11 (ITO, EX-160) in people with Healthy, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
The aims of the study are to investigate the physiological responses associated with deqi during stimulation of the LI11 and LI4 acupuncture points and the correlation between the intensity of the deqi sensation to such responses. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Electroacupuncture to right LI4 and LI11 (ITO, EX-160)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- Mar 2012to Dec 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal healthy subjects who were naïve to acupuncture
- Able to read Chinese and no communication barrier
Who cannot join
- Subjects with medical disorders, including neurological and psychologic disorder
- Use of medications that may affect the cardiovascular system within one week
- Subjects with painful or uncomfortable sensations of upper and lower limbs
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Queen Elizabeth Hospital
Hong Kong, Hong Kong, 852
David TW Yu, Master, 852-26986216, davidyu03@yahoo.com.hk
About this study
The aims of the study are to investigate the physiological responses associated with deqi during stimulation of the LI11 and LI4 acupuncture points and the correlation between the intensity of the deqi sensation to such responses.
- Conditions
- Healthy
- Being tested
- Electroacupuncture to right LI4 and LI11 (ITO, EX-160), Sham Electroacupuncture to knee caps, Sham electroacupuncture to LI4 and LI11
- Keywords
- deqi electroacupuncture, BP HR HRV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroacupuncture to right LI4 and LI11 (ITO, EX-160)Device
Also called Electroacupuncture device, ITO, EX-160, Hannover, Germany
Electroacupuncture at 2Hz, 0.4m/sec pulse duration
Sham Electroacupuncture to knee capsDevice
Electroacupuncture at 2Hz, 0.4m/sec pulse duration
Sham electroacupuncture to LI4 and LI11Device
Electroacupuncture at 2Hz, 0.4m/sec pulse duration
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture to right LI4 and LI11 | Experimental | Not described Receives: Device: Electroacupuncture to right LI4 and LI11 (ITO, EX-160) |
| Electroacupuncture to knee caps | Sham comparator | Electroacupuncture to knee caps Receives: Device: Sham Electroacupuncture to knee caps |
| Sham electroacupuncture to LI4 & LI11 | Placebo comparator | Not described Receives: Device: Sham electroacupuncture to LI4 and LI11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological Changes Associated with Deqi during Electroacupuncture to Right LI4 and LI11
heart rate variability
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2012
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Tai Wai David, The Hong Kong Polytechnic University
- Investigators
- David TW YU, Master, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564927
- Sponsor's protocol ID
- HSEARS20110510001
- Status last verified
- Mar 2012
- First submitted
- 21 Mar 2012
- Last updated
- 28 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Changes Associated With Deqi During Electroacupuncture to Right LI4 and LI11
- ClinicalTrials.gov ID
- NCT01564927
- Acronym / sponsor ID
- HSEARS20110510001
- Conditions
- Healthy
- Keywords
- deqi electroacupuncture, BP HR HRV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Dec 2012 (estimated)
- First posted
- 28 Mar 2012 (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 aims of the study are to investigate the physiological responses associated with deqi during stimulation of the LI11 and LI4 acupuncture points and the correlation between the intensity of the deqi sensation to such responses.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture to right LI4 and LI11 | Experimental | Device: Electroacupuncture to right LI4 and LI11 (ITO, EX-160) |
| Electroacupuncture to knee caps | Sham comparator | Device: Sham Electroacupuncture to knee capsElectroacupuncture to knee caps |
| Sham electroacupuncture to LI4 & LI11 | Placebo comparator | Device: Sham electroacupuncture to LI4 and LI11 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Normal healthy subjects who were naïve to acupuncture
- Able to read Chinese and no communication barrier
Key exclusion criteria (3 listed)
- Subjects with medical disorders, including neurological and psychologic disorder
- Use of medications that may affect the cardiovascular system within one week
- Subjects with painful or uncomfortable sensations of upper and lower limbs
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 |
|---|---|---|
| Electroacupuncture to right LI4 and LI11 (ITO, EX-160)Also: Electroacupuncture device, ITO, EX-160, Hannover, GermanyElectroacupuncture at 2Hz, 0.4m/sec pulse duration | Device | Electroacupuncture to right LI4 and LI11 |
| Sham Electroacupuncture to knee capsElectroacupuncture at 2Hz, 0.4m/sec pulse duration | Device | Electroacupuncture to knee caps |
| Sham electroacupuncture to LI4 and LI11Electroacupuncture at 2Hz, 0.4m/sec pulse duration | Device | Sham electroacupuncture to LI4 & LI11 |
Primary outcome
Physiological Changes Associated with Deqi during Electroacupuncture to Right LI4 and LI11
Time frame: One day
heart rate variability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 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.
David TW YU, Master principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture to right LI4 and LI11 (ITO, EX-160) in people with Healthy, run by The Hong Kong Polytechnic University at 1 site in China.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Mar 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 China. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David TW YU, Master (852-29586216, davidyu03@yahoo.com.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological Changes Associated with Deqi during Electroacupuncture to Right LI4 and LI11 (time frame: One day). 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 28 Mar 2012.