The Study on the Relationship Among Meridian, Acupoint and Internal Visceral Organs

NCT ID: NCT04172298

Last Updated: 2019-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2019-11-01

Brief Summary

The study on the relationship among meridian, acupoint and internal

Detailed 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.

Conditions

Meridian

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

sham electroacupuncture (EA) session

Intervention Type: OTHER

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.

Group Type: EXPERIMENTAL

Zusanli session

Intervention Type: OTHER

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).

Group Type: EXPERIMENTAL

Shaohai session

Intervention Type: OTHER

The methods were identical Zusanli group, but Shaohai acupoint (cathode), and 3 cm below Shaohai (anion).

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Shaohai session

The methods were identical Zusanli group, but Shaohai acupoint (cathode), and 3 cm below Shaohai (anion).

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

China Medical University Hospital

Taichung, North District, Taiwan

Countries

Taiwan

Other Identifiers

CMUH106-REC1-089

Identifier Type: -

Identifier Source: org_study_id