NCT07496697

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 30, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Completed
Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

March 22, 2026

Last Update Submit

June 22, 2026

Conditions

Keywords

ElectroacupunctureBowel SoundsTongbian (NP82)Daheng (SP15)Digital Stethoscope

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

  • Minimum SSI Ratio (SSIR)

    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.

Study Arms (1)

Electroacupuncture Group

EXPERIMENTAL

This 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.

Procedure: Electroacupuncture at NP82 (Tongbian) and SP15 (Daheng)

Interventions

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.

Also known as: EA at NP82 and SP15 points
Electroacupuncture Group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ho Chi Minh City, Ho Chi Minh, 72200, Vietnam

RECRUITING

Related Publications (6)

  • 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.

  • 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.

  • 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.

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

    RESULT
  • 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.

  • 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.

Study Officials

  • Minh Quan Le Hoang, MSc, MD

    University of Medicine and Pharmacy at Ho Chi Minh City

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Minh Quan Le Hoang, MSc, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer at the University of Medicine and Pharmacy at Ho Chi Minh City

Study Record Dates

First Submitted

March 22, 2026

First Posted

March 27, 2026

Study Start

April 30, 2026

Primary Completion

June 21, 2026

Study Completion

July 30, 2026

Last Updated

June 24, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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.

Locations