Effect of Electroacupuncture at Neiguan on Cardiac and Gastric Function

NCT ID: NCT05279404

Last Updated: 2022-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-15

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiac and Gastric Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

electroacupuncture

Intervention Type OTHER

Electroacupuncture at Neiguan and Jianshi acupoint

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.

Group Type SHAM_COMPARATOR

electroacupuncture

Intervention Type OTHER

Electroacupuncture at Neiguan and Jianshi acupoint

Interventions

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electroacupuncture

Electroacupuncture at Neiguan and Jianshi acupoint

Intervention Type OTHER

Other Intervention Names

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acupuncture

Eligibility Criteria

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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

* (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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Ching-Liang Hsieh

Role: CONTACT

04-22053366 ext. #3127

Other Identifiers

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CMUH110-REC2-211

Identifier Type: -

Identifier Source: org_study_id

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