AcupunctureNCT05249010
The Effect of Moxibustion on the Meridian
An observational study of Acupuncture and Moxibustion, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to combine the Chinese medicine and physics, using acupuncture to conduct electrical measurement, and to understand the effects of moxibustion on meridian. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acupuncture, Moxibustion
- What is being tested?
- acupuncture and moxibustion
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Mar 2022to 31 Dec 2022
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited from those considered healthy and at least 20 years old who agreed to the informed consent. The exclusion criteria for this study were: those under 20 years old, pregnant or breast-feeding women, those with an empty stomach before the study, a tendency toward bleeding with thrombocytopenia or platelets < 20000 or a user of an anti-platelet drug.
Who may be able to join
- at least 20 years old
- agree to the informed consent
Who cannot join
- under 20 years old
- pregnant or breast-feeding women
- those with an empty stomach before the study
- a tendency toward bleeding with thrombocytopenia or history of platelets < 20000 or a user of an anti-platelet drug.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Sun Yat-Sen University
Kaohsiung City, 833
Chien-Hung Lin, Dr., +886-7-7317123 ext. 2335, b9505027@cgmh.org.tw
About this study
Official title: The Effect of Moxibustion on the Meridian: A Prospective, Crossover Designed, Observational Study
The purpose of this study is to combine the Chinese medicine and physics, using acupuncture to conduct electrical measurement, and to understand the effects of moxibustion on meridian.
Read the detailed description
Moxibustion is a traditional Chinese medicine, which use the burned moxa to generate warmth on the human's local skin and then exerts a therapeutic effect. Research found that moxibustion has effect on analgesic and anti-inflammation, which can be applied on myofascial pain, insomnia, osteoarthritis, osteoporosis, cancer related fatigue, irritable bowel disease etc.. Although research reveal that moxibustion can treat these diseases probably by effect on analgesic and anti-inflammation, the mechanism of moxibustion is still not clear.
In modern study, the meridian has electric characteristic and the therapeutic effect of acupuncture may be related to the electricity resulting by acupuncture manipulation. However, there is no study to investigate the electric effect of moxibustion on the meridian. In our study, the investigators applied the semiconductor analyzer Agilent B1500A to investigate the electric characteristic of meridians and visual analogue scale (VAS) before and after moxibustion, which may provide another vision on moxibustion in the future.
The investigators intend to recruit 30 healthy participants with age more than 20 years old to participate this study. The participants receive acupuncture and then measure the VAS and electric characteristic by the semiconductor analyzer Agilent B1500A immediately(baseline data). The investigators add the burned moxa on the acupuncture as a method for moxibustion. After the moxa burned out, the investigators measure the VAS and electric characteristic immediately again(post moxibustion data). The investigators will use paired t test and repeated measure two ways ANOVA to compare the VAS and electricity of baseline data and post moxibustion data in each participant.
The purpose of this study is to combine the Chinese medicine and physics, using acupuncture to conduct electrical measurement, and to understand the effects of moxibustion on meridian.
- Conditions
- Acupuncture, Moxibustion
- Being tested
- acupuncture and moxibustion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture and moxibustionProcedure or surgery
Participants receive acupuncture and then measure the VAS and electric characteristic by the semiconductor analyzer Agilent B1500A first. The investigators add the burned moxa on the acupuncture as a method for moxibustion, and then measure the VAS and electric characteristic again.
| Study group | Role | What they receive |
|---|---|---|
| acupuncture and moxibustion group | The investigators intend to recruit 30 participants who receive acupuncture and then measure the VAS and electric characteristic by the semiconductor analyzer Agilent B1500A first. The investigators add the burned moxa on the acupuncture as a method for moxibustion, and then measure the VAS and electric characteristic again. Receives: Procedure: acupuncture and moxibustion |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of visual analogue scale (VAS), score from 0 to 10, the lower score means less pain while the higher score means more pain.
The investigators measure visual analogue score immediately after intervention of acupuncture (baseline data) and moxibustion (post moxibustion data) respectively.
Measured time baseline data: immediately after acupuncture post moxibustion data: immediately after moxa burned out (10 minutes)
Measured: through study completion, an average of 90 minutes
The change of electric current
Agilent B1500A is a device that can measure the electric current after acupuncture and moxibustion. The investigators measure the electric current after intervention of acupuncture (baseline data) and moxibustion (post moxibustion data) respectively.
Measured time:
baseline data: immediately after acupuncture post moxibustion data: immediately after moxa burned out (10 minutes)
Measured: through study completion, an average of 90 minutes
The change of voltage
Agilent B1500A is a device that can measure the voltage after acupuncture and moxibustion. The investigators measure the voltage after intervention of acupuncture (baseline data) and moxibustion (post moxibustion data) respectively.
Measured time:
baseline data: immediately after acupuncture post moxibustion data: immediately after moxa burned out (10 minutes)
Measured: through study completion, an average of 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start29 Mar 2022
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AcupunctureStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Chiang Hung, Professor, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249010
- Sponsor's protocol ID
- 202101924A3
- Status last verified
- Jan 2022
- First submitted
- 28 Jan 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
He XR, Wang Q, Li PP. Acupuncture and moxibustion for cancer-related fatigue: a systematic review and meta-analysis. Asian Pac J Cancer Prev. 2013;14(5):3067-74. doi: 10.7314/apjcp.2013.14.5.3067.
PubMed 23803081Lim MY, Huang J, Zhao B. Standardisation of moxibustion: challenges and future development. Acupunct Med. 2015 Apr;33(2):142-7. doi: 10.1136/acupmed-2014-010688. Epub 2014 Dec 15.
PubMed 25510253Hung YC, Chen WC, Chang TC, Zheng HX, Liu YW, Tan YF, Lin SK, Lu YH, Hu WL, Tsai TM. Meridian study on the response current affected by electrical pulse and acupuncture. Nanoscale Res Lett. 2020 Jul 10;15(1):146. doi: 10.1186/s11671-020-03373-2.
PubMed 32651748
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Moxibustion on the Meridian: A Prospective, Crossover Designed, Observational Study
- ClinicalTrials.gov ID
- NCT05249010
- Acronym / sponsor ID
- 202101924A3
- Conditions
- Acupuncture, Moxibustion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 21 Feb 2022 (actual)
- 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 this study is to combine the Chinese medicine and physics, using acupuncture to conduct electrical measurement, and to understand the effects of moxibustion on meridian.
Detailed description
Moxibustion is a traditional Chinese medicine, which use the burned moxa to generate warmth on the human's local skin and then exerts a therapeutic effect. Research found that moxibustion has effect on analgesic and anti-inflammation, which can be applied on myofascial pain, insomnia, osteoarthritis, osteoporosis, cancer related fatigue, irritable bowel disease etc.. Although research reveal that moxibustion can treat these diseases probably by effect on analgesic and anti-inflammation, the mechanism of moxibustion is still not clear.
In modern study, the meridian has electric characteristic and the therapeutic effect of acupuncture may be related to the electricity resulting by acupuncture manipulation. However, there is no study to investigate the electric effect of moxibustion on the meridian. In our study, the investigators applied the semiconductor analyzer Agilent B1500A to investigate the electric characteristic of meridians and visual analogue scale (VAS) before and after moxibustion, which may provide another vision on moxibustion in the future.
The investigators intend to recruit 30 healthy participants with age more than 20 years old to participate this study. The participants receive acupuncture and then measure the VAS and electric characteristic by the semiconductor analyzer Agilent B1500A immediately(baseline data). The investigators add the burned moxa on the acupuncture as a method for moxibustion. After the moxa burned out, the investigators measure the VAS and electric characteristic immediately again(post moxibustion data). The investigators will use paired t test and repeated measure two ways ANOVA to compare the VAS and electricity of baseline data and post moxibustion data in each participant.
The purpose of this study is to combine the Chinese medicine and physics, using acupuncture to conduct electrical measurement, and to understand the effects of moxibustion on meridian.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acupuncture and moxibustion group | – | Procedure: acupuncture and moxibustionThe investigators intend to recruit 30 participants who receive acupuncture and then measure the VAS and electric characteristic by the semiconductor analyzer Agilent B1500A first. The investigators add the burned moxa on the acupuncture as a method for moxibustion, and then measure the VAS and electric characteristic again. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from those considered healthy and at least 20 years old who agreed to the informed consent. The exclusion criteria for this study were: those under 20 years old, pregnant or breast-feeding women, those with an empty stomach before the study, a tendency toward bleeding with thrombocytopenia or platelets < 20000 or a user of an anti-platelet drug.
Key inclusion criteria (2 listed)
- at least 20 years old
- agree to the informed consent
Key exclusion criteria (4 listed)
- under 20 years old
- pregnant or breast-feeding women
- those with an empty stomach before the study
- a tendency toward bleeding with thrombocytopenia or history of platelets < 20000 or a user of an anti-platelet drug.
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 moxibustionParticipants receive acupuncture and then measure the VAS and electric characteristic by the semiconductor analyzer Agilent B1500A first. The investigators add the burned moxa on the acupuncture as a method for moxibustion, and then measure the VAS and electric characteristic again. | Procedure or surgery | acupuncture and moxibustion group |
Primary outcome
change of visual analogue scale (VAS), score from 0 to 10, the lower score means less pain while the higher score means more pain.
Time frame: through study completion, an average of 90 minutes
The investigators measure visual analogue score immediately after intervention of acupuncture (baseline data) and moxibustion (post moxibustion data) respectively. Measured time baseline data: immediately after acupuncture post moxibustion data: immediately after moxa burned out (10 minutes)
The change of electric current
Time frame: through study completion, an average of 90 minutes
Agilent B1500A is a device that can measure the electric current after acupuncture and moxibustion. The investigators measure the electric current after intervention of acupuncture (baseline data) and moxibustion (post moxibustion data) respectively. Measured time: baseline data: immediately after acupuncture post moxibustion data: immediately after moxa burned out (10 minutes)
The change of voltage
Time frame: through study completion, an average of 90 minutes
Agilent B1500A is a device that can measure the voltage after acupuncture and moxibustion. The investigators measure the voltage after intervention of acupuncture (baseline data) and moxibustion (post moxibustion data) respectively. Measured time: baseline data: immediately after acupuncture post moxibustion data: immediately after moxa burned out (10 minutes)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Background: PubMed 23803081He XR, Wang Q, Li PP. Acupuncture and moxibustion for cancer-related fatigue: a systematic review and meta-analysis. Asian Pac J Cancer Prev. 2013;14(5):3067-74. doi: 10.7314/apjcp.2013.14.5.3067.
- Background: PubMed 25510253Lim MY, Huang J, Zhao B. Standardisation of moxibustion: challenges and future development. Acupunct Med. 2015 Apr;33(2):142-7. doi: 10.1136/acupmed-2014-010688. Epub 2014 Dec 15.
- Background: PubMed 32651748Hung YC, Chen WC, Chang TC, Zheng HX, Liu YW, Tan YF, Lin SK, Lu YH, Hu WL, Tsai TM. Meridian study on the response current affected by electrical pulse and acupuncture. Nanoscale Res Lett. 2020 Jul 10;15(1):146. doi: 10.1186/s11671-020-03373-2.
- Individual participant dataSharing planned: Undecided
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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.
Yu-Chiang Hung, Professor study director
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acupuncture and Moxibustion, run by Chang Gung Memorial 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 2 inclusion and 4 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 25 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chien Hung Lin, Dr. (07-7317123 ext. 2335, b9505027@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of visual analogue scale (VAS), score from 0 to 10, the lower score means less pain while the higher score means more pain. (time frame: through study completion, an average of 90 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05249010, which also lists 3 linked publications.
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 25 Apr 2022.