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Gastrointestinal MotilityEABM-HVNCT07496697

Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects

A study testing Electroacupuncture at NP82 (Tongbian) and SP15 (Daheng) in people with Gastrointestinal Motility and Healthy, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to investigate how a specific combination of electroacupuncture points, Tongbian (NP82) and Daheng (SP15), affects bowel movements in healthy volunteers. Constipation is a significant health issue, especially for post-stroke patients, and current treatments like laxatives often have unwanted side… Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Gastrointestinal Motility, Healthy
What is being tested?
Electroacupuncture at NP82 (Tongbian) and SP15 (Daheng)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteVietnam
Study dates
30 Apr 2026to 30 Jul 2026
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 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy volunteers aged 18 years and older.
  • No symptoms related to constipation after comprehensive evaluation based on Rome IV criteria.
  • No gastrointestinal symptoms (abdominal pain, diarrhea, blood in stool, constipation, or bloating) in the 4 weeks prior to study participation.
  • No use of medications that promote or inhibit bowel motility in the 4 weeks prior to participation (including prokinetics, laxatives, antispasmodics, or opioids).
  • Fasting for at least 4 hours before the study session.
  • No mental or intellectual disorders; capable of understanding the acupuncture and assessment procedures.
  • Willingness to participate and signed informed consent form.

Who cannot join

  • Participants with severe medical conditions (heart, brain, liver, kidney, hematological system, infectious diseases, cancer, or psychiatric disorders).
  • Metabolic or functional disorders such as irritable bowel syndrome (IBS), thyroid dysfunction, or glucose/lipid metabolism disorders.
  • Use of bowel motility-altering medications within the 4 weeks prior to participation.
  • Participation in other clinical trials within the last 2 months.
  • Received acupuncture treatment within the last month.
  • Skin ulcers, abscesses, or infections at the acupuncture sites.
  • Known metal allergy or severe needle phobia.

Trial locations and contacts

1 site in 1 country.

Vietnam1 site
  • Faculty of Traditional Medicine, University of Medicine and Pharmacy at Ho Chi Minh City

    Ho Chi Minh City, Ho Chi Minh, 72200

Other trials in Vietnam

About this study

Official title: Investigation of Bowel Motility Changes Following Electroacupuncture at NP82 (Tongbian) and SP15 (Daheng) Acupoint Pair in Healthy Volunteers

This study aims to investigate how a specific combination of electroacupuncture points, Tongbian (NP82) and Daheng (SP15), affects bowel movements in healthy volunteers. Constipation is a significant health issue, especially for post-stroke patients, and current treatments like laxatives often have unwanted side effects. The researchers want to determine if stimulating these two acupuncture points can objectively increase the frequency of bowel activity.

Participants will undergo a three-stage procedure: a 30-minute period of baseline bowel sound recording, followed by 20 minutes of electroacupuncture stimulation at the specific points, and a final 30-minute recording period after the intervention. Throughout the study, an advanced digital stethoscope (3M™ Littmann® CORE) will be used to record bowel sounds objectively. This data will then be analyzed to measure any significant changes in bowel motility caused by the acupuncture.

Read the detailed description

Background and Rationale:

Bowel motility is a fundamental physiological function regulated by the autonomic nervous system. This study explores the potential of electroacupuncture (EA) to modulate this activity using a unique acupoint combination: Dai Hoanh (SP15), a classic point known for regulating the Spleen and Stomach, and Thong Tien (NP82), a newly proposed "extra point" specifically indicated for treating paralysis-related constipation in traditional literature. The study aims to provide the first modern scientific evidence for the effectiveness of NP82 in stimulating bowel motility.

Methodology:

The study follows a before-and-after intervention design involving 30 healthy volunteers. To ensure objective measurement, bowel sounds are recorded using the 3M™ Littmann® CORE Digital Stethoscope, which amplifies sounds and allows for computerized analysis, overcoming the subjectivity of traditional auscultation.

The procedure consists of three phases:

  1. Baseline Phase: Continuous 30-minute recording of bowel sounds to establish a physiological reference.
  2. Intervention Phase: Simultaneous 20-minute recording during EA. Sterile needles (0.30×40mm) are inserted into NP82 and SP15 points until "De Qi" sensation is achieved. Stimulation utilizes a dense-disperse wave at a 10 Hz frequency, with intensity adjusted (0.1-1 mA) based on participant tolerance.
  3. Post-intervention Phase: Continuous 30-minute recording after needle removal to evaluate sustained effects.

Blinded Outcome Assessment Note:

Although the clinical phase of this trial is formally registered as open-label (None/Open) due to its single-arm pre-post interventional design, a rigorous blinded outcome assessment was implemented during data analysis. The raw digital acoustic recordings were completely de-identified, randomized, and assigned arbitrary codes. The independent clinical experts responsible for manual bowel sound annotation and validation were fully masked to the participants' identities and the chronological sequence of the recording phases (baseline, active electroacupuncture, or post-intervention).

Data Analysis:

Automated signal preprocessing, ARMA-based event segmentation, and acoustic parameter extraction will be executed using Python programming software (version 3.10 or later) utilizing the SciPy and NumPy packages. All subsequent statistical analyses will be performed using R statistical software (version 4.3.0 or later; R Core Team, Vienna, Austria). Since acoustic bowel motility parameters do not exhibit a normal distribution (evaluated via the Shapiro-Wilk test), non-parametric paired Wilcoxon signed-rank tests will be utilized for all pairwise comparisons across the three experimental phases (baseline vs. active intervention, baseline vs. post-intervention, and active intervention vs. post-intervention). Continuous variables will be reported as Medians with Interquartile Ranges (IQR). A p-value of < 0.05 will establish the threshold for statistical significance for all tests

Being tested
Electroacupuncture at NP82 (Tongbian) and SP15 (Daheng)
Keywords
Electroacupuncture, Bowel Sounds, Tongbian (NP82), Daheng (SP15), Digital Stethoscope

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electroacupuncture at NP82 (Tongbian) and SP15 (Daheng)Procedure or surgery

    Also called EA at NP82 and SP15 points

    The intervention is performed by practitioners with at least 3 years of experience. Sterile acupuncture needles (0.30×40mm) are inserted vertically into the Tongbian (NP82 - located 3 cun lateral to the umbilicus) and Daheng (SP15 - located 4 cun lateral to the umbilicus) acupoints. Insertion depth ranges from 20 to 65 mm depending on the participant's body type, aiming to achieve the "De Qi" sensation (aching, heaviness, and tension). Electrical stimulation is applied using a Hwato SDZ-III device with a dense-disperse wave at a frequency of 10 Hz for 20 minutes. The current intensity is adjusted (0.1-1 mA) until a mild muscle vibration is visible without causing pain to the participant.

Study groups in NCT07496697
Study groupRoleWhat they receive
Electroacupuncture GroupExperimentalThis single group of 30 healthy volunteers will undergo a three-phase sequential protocol where each participant serves as their own control[cite: 139, 140, 161]. The procedure includes: (1) a 30-minute baseline bowel sound recording; (2) a 20-minute electroacupuncture session at acupoints NP82 and SP15 with simultaneous recording; and (3) a 30-minute post-intervention recording to evaluate sustained effects[cite: 171, 172, 179, 181, 182]. Bowel sounds are captured objectively using a 3M™ Littmann® CORE Digital Stethoscope.
Receives: Procedure: Electroacupuncture at NP82 (Tongbian) and SP15 (Daheng)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bowel Sound Interval (SSI)

    SSI is the time interval between the end of one bowel sound event and the start of the next. Bowel sounds are recorded and quantified using the 3M™ Littmann® CORE Digital Stethoscope and analyzed with Stata 17.0 software to determine changes in bowel motility.

    Measured: Continuous recording across three phases: Baseline (30 minutes before intervention), During Intervention (20 minutes), and Post-intervention (30 minutes).

Secondary outcomes (3)
  1. Minimum SSI Ratio (SSIR)

    SSIR is calculated as the ratio of the minimum Bowel Sound Interval (SSI) during or after the intervention (Ba) to the minimum SSI before the intervention (Bb). SSI values are derived from digital recordings of bowel sounds captured by a 3M™ Littmann® CORE Digital Stethoscope. The analysis focuses on 10-minute windows within each phase to determine the maximum increase in bowel motility compared to the baseline.

    Measured: The total study duration is 80 minutes, consisting of: (1) Baseline phase: 30 minutes before intervention; (2) Intervention phase: 20 minutes during electroacupuncture; and (3) Post-intervention phase: 30 minutes after needle removal.

  2. Bowel Sound Duration Ratio (BSDR)

    Defined as the percentage of the total analytical window duration occupied by active bowel sound events. To account for the unequal durations of the study phases, this metric is calculated using a phase-dependent denominator T as follows: BSDR (%) = (Total BS Duration / T) * 100%, where T = 30 minutes for the baseline and post-intervention phases, and T = 20 minutes for the active electroacupuncture phase

    Measured: Continuous recording across three phases: Baseline (30 minutes), Active Electroacupuncture (20 minutes), and Post-intervention (30 minutes)

  3. Bowel Sound Frequency

    Defined as the number of independent bowel sound events detected per minute within each study phase. This metric is computed as the total count of bowel sound events divided by the phase-specific window duration T (where T = 30 minutes for the baseline and post-intervention phases, and T = 20 minutes for the active electroacupuncture phase)

    Measured: Continuous recording across three phases: Baseline (30 minutes), Active Electroacupuncture (20 minutes), and Post-intervention (30 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study start30 Apr 2026
  3. Primary completion21 Jun 2026
  4. Study completion30 Jul 2026

Resources

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
Not applicable
Intervention model
Single group
Model description
This is a single-arm, pre-post interventional study where each participant serves as their own control. The protocol consists of three consecutive phases: (1) a 30-minute baseline bowel sound recording phase, (2) a 20-minute recording phase during electroacupuncture stimulation at acupoints NP82 and SP15, and (3) a 30-minute post-intervention recording phase\[cite: 171, 181, 182\]. Bowel motility changes are assessed by comparing quantitative acoustic data captured during these three sequential stages.
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07496697
Sponsor's protocol ID
473/HĐ-ĐHYD
Other IDs
473/HĐ-ĐHYD
Acronym
EABM-HV
Status last verified
Aug 2026
First submitted
22 Mar 2026
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is currently no plan to share individual participant data (IPD) to ensure the confidentiality of participants. However, the study results and findings will be disseminated in aggregate form through publications in peer-reviewed journals.

Publications

  • Wang G, Wang M, Liu H, Zhao S, Liu L, Wang W. Changes in bowel sounds of inpatients undergoing general anesthesia. Biomed Eng Online. 2020 Jul 30;19(1):60. doi: 10.1186/s12938-020-00805-z.

    PubMed 32731903
  • Emoto T, Shono K, Abeyratne UR, Okahisa T, Yano H, Akutagawa M, Konaka S, Kinouchi Y. ARMA-based spectral bandwidth for evaluation of bowel motility by the analysis of bowel sounds. Physiol Meas. 2013 Aug;34(8):925-36. doi: 10.1088/0967-3334/34/8/925. Epub 2013 Jul 26.

    PubMed 23893043
  • Ong SS, Tang T, Xu L, Xu C, Li Q, Deng X, Shen P, Chen Y, Song Y, Lu H, Fang L. Research on the mechanism of core acupoints in electroacupuncture for functional constipation based on data mining and network acupuncture. Front Med (Lausanne). 2024 Dec 11;11:1482066. doi: 10.3389/fmed.2024.1482066. eCollection 2024.

    PubMed 39722820
  • Lê QNL, Tú Vân. Từ Điển Huyệt Vị Châm Cứu (Tái Bản). Nhà Xuất Bản Thuận Hóa; 2016.

  • Abbasi P, Mojalli M, Kianmehr M, Zamani S. Effect of acupressure on constipation in patients undergoing hemodialysis: A randomized double-blind controlled clinical trial. Avicenna J Phytomed. 2019 Jan-Feb;9(1):84-91.

    PubMed 30788281
  • Zhao X, Liu L, Diao Y, Ma C. Effectiveness of abdominal electroacupuncture therapy for poststroke constipation: a meta-analysis. Front Neurol. 2024 Nov 22;15:1480681. doi: 10.3389/fneur.2024.1480681. eCollection 2024.

    PubMed 39650243

Questions about this trial

What is this clinical trial studying?

A study testing Electroacupuncture at NP82 (Tongbian) and SP15 (Daheng) in people with Gastrointestinal Motility and Healthy, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.

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 7 inclusion and 7 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 17 Aug 2026. 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 Vietnam. 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. 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?

Bowel Sound Interval (SSI) (time frame: Continuous recording across three phases: Baseline (30 minutes before intervention), During Intervention (20 minutes), and Post-intervention (30 minutes).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07496697, which also lists 6 linked publications.

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 17 Aug 2026.

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