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

• Sponsor: China Medical University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04172298
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Arms: 3
• Actual Duration (Months): 27
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The study on the relationship among meridian, acupoint and internal

Condition or Disease	Intervention/Treatment	Phase
Meridian	Other: sham electroacupuncture (EA) session; Other: Zusanli session; Other: Shaohai session	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: The Study on the Relationship Among Meridian, Acupoint and Internal Visceral Organs
• Actual Study Start Date: Aug 1, 2017
• Actual Primary Completion Date: Nov 1, 2019
• Actual Study Completion Date: Nov 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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.	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.
Experimental: 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.	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.
Experimental: Shaohai session The methods were identical Zusanli group, but Shaohai acupoint (cathode), and 3 cm below Shaohai (anion).	Other: Shaohai session; The methods were identical Zusanli group, but Shaohai acupoint (cathode), and 3 cm below Shaohai (anion).

Outcome Measures

Primary Outcome Measures

1. electrogastrogram recordings [30 minutes in duration.]

   the changes of the percentage of gastric slow wave .

2. cardiac output [30 minutes in duration.]

   the changes of cardiac output .

3. cardiac output [30 minutes in duration.]

   the changes of stroke volume .

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	China Medical University Hospital	Taichung	North District	Taiwan	40447

Sponsors and Collaborators

• China Medical University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: China Medical University Hospital
• ClinicalTrials.gov Identifier: NCT04172298
• Other Study ID Numbers: CMUH106-REC1-089
• First Posted: Nov 21, 2019
• Last Update Posted: Nov 21, 2019
• Last Verified: Nov 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by China Medical University Hospital: Meridian; Internal visceral organs; Zusanli; Shaohai; Acupoint

Study Results

No Results Posted as of Nov 21, 2019