- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05249010
The Effect of Moxibustion on the Meridian
The Effect of Moxibustion on the Meridian: A Prospective, Crossover Designed, Observational Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Chien Hung Lin, Dr.
- Phone Number: 2335 07-7317123
- Email: b9505027@cgmh.org.tw
Study Locations
-
-
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Kaohsiung, Taiwan, 833
- Recruiting
- Sun Yat-sen University
-
Contact:
- Chien-Hung Lin, Dr.
- Phone Number: 2335 +886-7-7317123
- Email: b9505027@cgmh.org.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- at least 20 years old
- agree to the informed consent
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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) |
through study completion, an average of 90 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) |
through study completion, an average of 90 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) |
through study completion, an average of 90 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Yu-Chiang Hung, Professor, Chang Gung Memorial Hospital
Publications and helpful links
General 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.
- Lim 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.
- Hung 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 202101924A3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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