MeridianNCT04172298
The Study on the Relationship Among Meridian, Acupoint and Internal Visceral Organs
A study testing Zusanli session and Shaohai session in people with Meridian, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The study on the relationship among meridian, acupoint and internal Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Meridian
- What is being tested?
- Zusanli session and Shaohai session
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2017to 1 Nov 2019
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The study on the relationship among meridian, acupoint and internal
Read the 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.
- Conditions
- Meridian
- Being tested
- sham electroacupuncture (EA) session, Zusanli session, Shaohai session
- Keywords
- Meridian, Internal visceral organs, Zusanli, Shaohai, Acupoint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sham electroacupuncture (EA) sessionOther
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.
Zusanli sessionOther
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.
Shaohai sessionOther
The methods were identical Zusanli group, but Shaohai acupoint (cathode), and 3 cm below Shaohai (anion).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Zusanli session |
| Shaohai session | Experimental | The methods were identical Zusanli group, but Shaohai acupoint (cathode), and 3 cm below Shaohai (anion). Receives: Other: Shaohai session |
What is being measured
The primary outcome is the main question the study is designed to answer.
electrogastrogram recordings
the changes of the percentage of gastric slow wave .
Measured: 30 minutes in duration.
cardiac output
the changes of cardiac output .
Measured: 30 minutes in duration.
cardiac output
the changes of stroke volume .
Measured: 30 minutes in duration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start1 Aug 2017
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeridianStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
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
- NCT04172298
- Sponsor's protocol ID
- CMUH106-REC1-089
- Status last verified
- Nov 2019
- First submitted
- 15 Nov 2019
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study on the Relationship Among Meridian, Acupoint and Internal Visceral Organs
- ClinicalTrials.gov ID
- NCT04172298
- Acronym / sponsor ID
- CMUH106-REC1-089
- Conditions
- Meridian
- Keywords
- Meridian, Internal visceral organs, Zusanli, Shaohai, Acupoint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 21 Nov 2019 (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.
The study on the relationship among meridian, acupoint and internal
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sham electroacupuncture (EA) session | Placebo comparator | Other: sham electroacupuncture (EA) sessionThe 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. |
| Zusanli session | Experimental | Other: Zusanli sessionThe 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. |
| Shaohai session | Experimental | Other: Shaohai sessionThe methods were identical Zusanli group, but Shaohai acupoint (cathode), and 3 cm below Shaohai (anion). |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| sham electroacupuncture (EA) sessionThe 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 sessionThe 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 sessionThe methods were identical Zusanli group, but Shaohai acupoint (cathode), and 3 cm below Shaohai (anion). | Other | Shaohai session |
Primary outcome
electrogastrogram recordings
Time frame: 30 minutes in duration.
the changes of the percentage of gastric slow wave .
cardiac output
Time frame: 30 minutes in duration.
the changes of cardiac output .
cardiac output
Time frame: 30 minutes in duration.
the changes of stroke volume .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zusanli session and Shaohai session in people with Meridian, run by China Medical University Hospital at 1 site in Taiwan.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
electrogastrogram recordings (time frame: 30 minutes in duration.). The study lists 3 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 21 Nov 2019.