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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05249010
Other study ID # 202101924A3
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 29, 2022
Est. completion date December 31, 2022

Study information

Verified date January 2022
Source Chang Gung Memorial Hospital
Contact Chien Hung Lin, Dr.
Phone 07-7317123
Email b9505027@cgmh.org.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 31, 2022
Est. primary completion date August 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
acupuncture and moxibustion
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.

Locations

Country Name City State
Taiwan Sun Yat-Sen University Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
through study completion, an average of 90 minutes
Primary 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)
through study completion, an average of 90 minutes
Primary 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)
through study completion, an average of 90 minutes
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