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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04172298
Other study ID # CMUH106-REC1-089
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2017
Est. completion date November 1, 2019

Study information

Verified date November 2019
Source China Medical University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study on the relationship among meridian, acupoint and internal


Description:

Meridian system is the pathway of transporting qi and blood, and that distributes all the body. Meridian system connects to internal visceral organs interior, and also connects to joints (or acupoint) exterior. The relationship among meridian, acupoints and internal visceral organs is still unclear. Therefore, the purpose of the present study was to investigate the relationship among meridian, acupoints and internal visceral organs. Total 33 subjects randomly finished three sessional studies as follows: 1) sham electroacupuncture (EA) session: the stainless steels acupuncture needles inserted into the subcutaneous layer of Zusanli (cathode) and Shangjuxu acupints (anion) , and the needles connected to EA stimulator, but no electric discharge for 30 min; 2) Zusanli session: the acupuncture needles inserted into Zusanli (cathode) and Shangjuxu acupoints (anion), and twisting obtain qi, and the needles then connected to EA stimulator, the frequency was 2 Hz, the duration was 30 min, and the intensity was visual slightly muscle contraction; 3) Shaohai session: the methods were identical Zusanli group, but Shaohai acupoint (cathode), and 3 cm below Shaohai (anion) . The major outcome measure was the changes of the percentage of gastric slow wave and dysrhythmia in 30 min electrogastrogram recordings, and the changes of cardiac output and stroke volume in 30 min recordings. Secondary outcome measure was the changes of saliva, blood and urine metabolites.

The investigators predict the results of the present study can test and verify meridian theory of traditional Chinese Medicine, meridian system connects internal visceral organ interior, and connects joint (or acupoint) exterior.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date November 1, 2019
Est. primary completion date November 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria:

1. Gender:male or female.

2. Age:from 20 years old (inclusive) to 50 years old (inclusive).

3. After detailed description of the entire research purpose or process, voluntarily participate in the study and sign the consent form.

Exclusion Criteria:

1. Cancer, congestive hear failured NYHA class>II, COPD attack.

2. History of esophagus and gastroduodenal surgery?Barrett's esophagus.

3. Can not accept acupuncture points stimulators.

4. Allergic to acupuncture needles.

5. Has a mental illness or is unable to cooperate with the researcher.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
sham electroacupuncture (EA) session
The stainless steels acupuncture needles inserted into the subcutaneous layer of Zusanli (cathode) and Shangjuxu acupints (anion) , and the needles connected to EA stimulator, but no electric discharge for 30 min.
Zusanli session
The acupuncture needles inserted into Zusanli (cathode) and Shangjuxu acupoints (anion), and twisting obtain qi, and the needles then connected to EA stimulator, the frequency was 2 Hz, the duration was 30 min, and the intensity was visual slightly muscle contraction.
Shaohai session
The methods were identical Zusanli group, but Shaohai acupoint (cathode), and 3 cm below Shaohai (anion).

Locations

Country Name City State
Taiwan China Medical University Hospital Taichung North District

Sponsors (1)

Lead Sponsor Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary electrogastrogram recordings the changes of the percentage of gastric slow wave . 30 minutes in duration.
Primary cardiac output the changes of cardiac output . 30 minutes in duration.
Primary cardiac output the changes of stroke volume . 30 minutes in duration.
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