Cardiac and Gastric FunctionNCT05279404
Effect of Electroacupuncture at Neiguan on Cardiac and Gastric Function
A study testing electroacupuncture in people with Cardiac and Gastric Function, run by China Medical University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac and Gastric Function
- What is being tested?
- electroacupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Cardiac and Gastric Function
- Being tested
- electroacupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupunctureOther
Also called acupuncture
Electroacupuncture at Neiguan and Jianshi acupoint
| Study group | Role | What they receive |
|---|---|---|
| Group A - electroacupuncture | Experimental | 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. Receives: Other: electroacupuncture |
| Group B - Sham electroacupuncture | Sham comparator | 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. Receives: Other: electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: thirty minutes.
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.
Measured: thirty minutes.
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.
Measured: thirty minutes.
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.
Measured: thirty minutes.
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.
Measured: thirty minutes.
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.
Measured: thirty minutes.
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.
Measured: thirty minutes.
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.
Measured: thirty minutes.
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.
Measured: thirty minutes.
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.
Measured: thirty minutes.
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.
Measured: thirty minutes.
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.
Measured: thirty minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start15 Apr 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac and Gastric FunctionStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279404
- Sponsor's protocol ID
- CMUH110-REC2-211
- Status last verified
- Mar 2022
- First submitted
- 24 Jan 2022
- Last updated
- 15 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) would be protected.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electroacupuncture at Neiguan on Cardiac and Gastric Function
- ClinicalTrials.gov ID
- NCT05279404
- Acronym / sponsor ID
- CMUH110-REC2-211
- Conditions
- Cardiac and Gastric Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 15 Apr 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - electroacupuncture | Experimental | Other: electroacupunctureelectroacupuncture 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 B - Sham electroacupuncture | Sham comparator | Other: electroacupunctureSham 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- (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.
Key exclusion criteria (6 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electroacupunctureAlso: acupunctureElectroacupuncture at Neiguan and Jianshi acupoint | Other | Group A - electroacupuncture, Group B - Sham electroacupuncture |
Primary outcome
Cardiac Function
Time frame: thirty minutes.
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.
Cardiac Function
Time frame: thirty minutes.
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.
Cardiac Function
Time frame: thirty minutes.
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.
Cardiac Function
Time frame: thirty minutes.
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.
Cardiac Function
Time frame: thirty minutes.
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.
Cardiac Function
Time frame: thirty minutes.
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.
Gastric Function
Time frame: thirty minutes.
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.
Gastric Function
Time frame: thirty minutes.
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.
Gastric Function
Time frame: thirty minutes.
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.
Gastric Function
Time frame: thirty minutes.
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.
Gastric Function
Time frame: thirty minutes.
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.
Gastric Function
Time frame: thirty minutes.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: No. Individual participant data (IPD) would be protected.
Related trials for Cardiac and Gastric Function
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The TRIABETES - ARMMS-T2D Study: A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes
Type 2 Diabetes Mellitus, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture in people with Cardiac and Gastric Function, run by China Medical University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ching-Liang Hsieh (04-22053366 ext. #3127, clhsieh@mail.cmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Function (time frame: thirty minutes.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.