NCT04172298

Brief Summary

The study on the relationship among meridian, acupoint and internal

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
Last Updated

November 21, 2019

Status Verified

November 1, 2019

Enrollment Period

2.3 years

First QC Date

November 15, 2019

Last Update Submit

November 19, 2019

Conditions

Keywords

MeridianInternal visceral organsZusanliShaohaiAcupoint

Outcome Measures

Primary Outcomes (3)

  • electrogastrogram recordings

    the changes of the percentage of gastric slow wave .

    30 minutes in duration.

  • cardiac output

    the changes of cardiac output .

    30 minutes in duration.

  • cardiac output

    the changes of stroke volume .

    30 minutes in duration.

Study Arms (3)

sham electroacupuncture (EA) session

PLACEBO COMPARATOR

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

Zusanli session

EXPERIMENTAL

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

Shaohai session

EXPERIMENTAL

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

Other: Shaohai session

Interventions

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.

sham electroacupuncture (EA) 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.

Zusanli session

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

Shaohai session

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Gender:male or female.
  • Age:from 20 years old (inclusive) to 50 years old (inclusive).
  • After detailed description of the entire research purpose or process, voluntarily participate in the study and sign the consent form.

You may not qualify if:

  • Cancer, congestive hear failured NYHA class\>II, COPD attack.
  • History of esophagus and gastroduodenal surgery、Barrett's esophagus.
  • Can not accept acupuncture points stimulators.
  • Allergic to acupuncture needles.
  • Has a mental illness or is unable to cooperate with the researcher.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, North District, 40447, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2019

First Posted

November 21, 2019

Study Start

August 1, 2017

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

November 21, 2019

Record last verified: 2019-11

Locations