CClinicalTrials.gg
Status unknownNCT05279404Updated Mar 15, 2022

Effect of Electroacupuncture at Neiguan on Cardiac and Gastric Function

An interventional study of electroacupuncture in Cardiac and Gastric Function, sponsored by China Medical University Hospital. Status unknown. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-15.

Sponsored by China Medical University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Study summary

Acupuncture have been used in clinical treatment of diseases for at least 3,000 years, and the efficacy of acupuncture has been recognized by countries all over the world. However, most of the selected points for acupuncture treatment of diseases are based on ancient books or inheritance of experience. For example, the " Shizong Acupoint Ballad " of acupuncture records: "Neiguan (PC6) care about the chest and stomach", that is, acupuncture Neiguan can be used to treat chest, heart and stomach diseases. However, there is no scientific evidence to verify this argument so far that the Shizong Acupoint Ballad mentions "Neiguan care for the chest and stomach", and that means that Neiguan acupoint can treat the diseases of cardiovascular system and gastrointestinal system. The purpose is to verify the argument of "Neiguan care about the chest and stomach", and design a clinical trial of the Neiguan and Jianshi (PC5) on both sides of the electroacupuncture (EA) to simultaneously evaluate the heart and stomach functions. We designed a crossover test; total 72 subjects randomly equally divide the into a sham group (sham electroacupuncture) and an EA group [2Hz EA (PC6 is cathode) and PC5 is anode]. At least one week of washing time, then the EA group changed to a sham group and the sham group changed to an EA group.

In this study, it is expected that the EA at PC6 and PC5 will affect the heart function and the function of the stomach at the same time, verifying the argument that "the PC6 care of the chest and stomach" recorded in the Shizong Acupoint Ballad.

02

Conditions studied

  • Cardiac and Gastric Function
03

In context

Lead sponsor

China Medical University Hospital is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • (1) Normal and healthy participants
  • (2) Male or female
  • (3) The age range is 20 to 40 years old.
  • (4) Those who participates and signs informed consent after explaining the research purpose and process in detail.

Exclusion criteria

Exclusion Criteria:

  • (1) Those with serious diseases, such as heart failure, chronic failure or cancer patients, etc.
  • (2) Those who are allergic to stainless steel needles for acupuncture.
  • (3) Pregnant or breastfeeding
  • (4) Those who are taking medicines or food such as coffee, etc. that will affect heart function such as heart rate, or gastric peristalsis.
  • (5) Unable to cooperate with researchers such as mental instability.
  • (6) Those who do not sign the consent form.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
72 participants (estimated)

Study arms

  • Experimental
    Group A - electroacupuncture

    electroacupuncture group Insert stainless steel acupuncture needles into Neiguan (cathode) and Jianshi (anode) on both sides and twist the needles. After that, the electroacupuncture machine was connected and 2 Hz electrical stimulation was administered for 30 minutes. The stimulation intensity was mainly based on slight muscle contractions and no pain in the subjects. At this time, cardiac function and electrogastrogram were recorded at the same time.

    Other: electroacupuncture

  • Sham comparator
    Group B - Sham electroacupuncture

    Sham electroacupuncture group The method was the same as that of the electroacupuncture group, but the needles were only acupuncture under the skin of Neiguan and Jianshi without twisting the needles. The electroacupuncture machine was connected but no electrical stimulation was administered.

    Other: electroacupuncture

Interventions

  • Otherelectroacupuncture

    Electroacupuncture at Neiguan and Jianshi acupoint

    Also known as: acupuncture

06

What researchers measure

Primary outcomes

  1. Cardiac Function

    Evaluation of cardiac function with the "Osypka" non-invasive cardiac output monitor before electroacupuncture interventions . Cardiac function (OSCAR, non-invasive cardiac output meter) is first recorded for 30 minutes, and then intervention (electroacupuncture) is implemented, and cardiac function is recorded at the same time.

    Time frame: thirty minutes.

  2. Cardiac Function

    Evaluation of cardiac function with the "Osypka" non-invasive cardiac output monitor during electroacupuncture interventions. Cardiac function (OSCAR, non-invasive cardiac output meter) is first recorded for 30 minutes, and then intervention (electroacupuncture) is implemented, and cardiac function is recorded at the same time.

    Time frame: thirty minutes.

  3. Cardiac Function

    Evaluation of cardiac function with the "Osypka" non-invasive cardiac output monitor after electroacupuncture interventions. Cardiac function (OSCAR, non-invasive cardiac output meter) is first recorded for 30 minutes, and then intervention (electroacupuncture) is implemented, and cardiac function is recorded at the same time.

    Time frame: thirty minutes.

  4. Cardiac Function

    After at least one week (washing time), the two groups would be switched, and cardiac function is measured once in the same pattern. Evaluation of cardiac function with the "Osypka" non-invasive cardiac output monitor before sham electroacupuncture interventions. Cardiac function (OSCAR, non-invasive cardiac output meter) is first recorded for 30 minutes, and then intervention (sham electroacupuncture) is implemented, and cardiac function is recorded at the same time.

    Time frame: thirty minutes.

  5. Cardiac Function

    After at least one week (washing time), the two groups would be switched, and cardiac function is measured once in the same pattern. Evaluation of cardiac function with the "Osypka" non-invasive cardiac output monitor during sham electroacupuncture interventions. Cardiac function (OSCAR, non-invasive cardiac output meter) is first recorded for 30 minutes, and then intervention (sham electroacupuncture) is implemented, and cardiac function is recorded at the same time.

    Time frame: thirty minutes.

  6. Cardiac Function

    After at least one week (washing time), the two groups would be switched, and cardiac function is measured once in the same pattern. Evaluation of cardiac function with the "Osypka" non-invasive cardiac output monitor after sham electroacupuncture interventions. Cardiac function (OSCAR, non-invasive cardiac output meter) is first recorded for 30 minutes, and then intervention (sham electroacupuncture) is implemented, and cardiac function is recorded at the same time.

    Time frame: thirty minutes.

  7. Gastric Function

    Evaluation of gastric electrical rhythm with electrogastrography before electroacupuncture interventions. Gastric function (electrogastrography) is first recorded for 30 minutes, and then intervention (electroacupuncture) is implemented, and gastric function is recorded at the same time.

    Time frame: thirty minutes.

  8. Gastric Function

    Evaluation of gastric electrical rhythm with electrogastrography during electroacupuncture interventions. Gastric function (electrogastrography) is first recorded for 30 minutes, and then intervention (electroacupuncture) is implemented, and gastric function is recorded at the same time.

    Time frame: thirty minutes.

  9. Gastric Function

    Evaluation of gastric electrical rhythm with electrogastrography after electroacupuncture interventions. Gastric function (electrogastrography) is first recorded for 30 minutes, and then intervention (electroacupuncture) is implemented, and gastric function is recorded at the same time.

    Time frame: thirty minutes.

  10. Gastric Function

    After at least one week (washing time), the two groups would be switched, and cardiac function is measured once in the same pattern. Evaluation of gastric electrical rhythm with electrogastrography before electroacupuncture and sham electroacupuncture interventions. Gastric function (sham electroacupuncture) is first recorded for 30 minutes, and then intervention (sham electroacupuncture) is implemented, and gastric function is recorded at the same time.

    Time frame: thirty minutes.

  11. Gastric Function

    After at least one week (washing time), the two groups would be switched, and cardiac function is measured once in the same pattern. Evaluation of gastric electrical rhythm with electrogastrography during electroacupuncture and sham electroacupuncture interventions. Gastric function (sham electroacupuncture) is first recorded for 30 minutes, and then intervention (sham electroacupuncture) is implemented, and gastric function is recorded at the same time.

    Time frame: thirty minutes.

  12. Gastric Function

    After at least one week (washing time), the two groups would be switched, and cardiac function is measured once in the same pattern. Evaluation of gastric electrical rhythm with electrogastrography after electroacupuncture and sham electroacupuncture interventions. Gastric function (sham electroacupuncture) is first recorded for 30 minutes, and then intervention (sham electroacupuncture) is implemented, and gastric function is recorded at the same time.

    Time frame: thirty minutes.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Individual participant data (IPD) would be protected.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05279404
Lead sponsor
China Medical University Hospital
Responsible party
Sponsor
First posted
Mar 15, 2022
Start date
Apr 15, 2022 (estimated)
Primary completion
Dec 1, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Mar 15, 2022

Study contacts

Ching-Liang Hsieh
Contact
clhsieh@mail.cmuh.org.tw
04-22053366 ext. #3127

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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