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Functional DyspepsiaNCT07496580

Efficacy Evaluation of Electroacupuncture in the Treatment of Functional Dyspepsia

A study testing Electroacupuncture (Local Acupoints) and Electroacupuncture (Distal Acupoints) in people with Functional Dyspepsia and Electroacupuncture, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 4 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Functional dyspepsia (FD) is a common disorder that causes stomach discomfort, such as fullness or pain after eating, without any visible structural disease. Acupuncture is often used to manage these symptoms. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Functional Dyspepsia, Electroacupuncture
What is being tested?
Electroacupuncture (Local Acupoints) and Electroacupuncture (Distal Acupoints)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
105 participants
Where
4 sitesChina
Study dates
1 Mar 2026to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants who meet the Rome IV diagnostic criteria for functional dyspepsia (FD).
  • Age 18 to 80 years, male or female.
  • Chinese patients with a normal upper gastrointestinal endoscopy within the past 1 year, or judged by a gastroenterologist with more than 3 years of clinical experience to have no structural disease that explains the symptoms.
  • Willing and able to provide written informed consent and comply with study procedures.

Who cannot join

  • Functional dyspepsia symptoms caused by severe or malignant diseases (e.g., liver cirrhosis, heart failure, or gastrointestinal tumors).
  • Helicobacter pylori infection, defined as a positive urea breath test or positive Hp test on endoscopy.
  • History of gastrointestinal surgery (except minimally invasive procedures such as laparoscopy).
  • Presence of a permanent or temporary cardiac pacemaker or use of external/temporary pacing support.
  • Use of medications that may affect dyspepsia symptoms within 2 weeks prior to enrollment, including antisecretory drugs, antacids, prokinetic agents, digestive enzymes, nonsteroidal anti-inflammatory drugs, antidepressants, or traditional Chinese medicine for FD.
  • Conditions that may make participation difficult, such as severe mental or physical illness, dementia, or illiteracy.
Show all 11Show fewer
  • Severe coagulation disorders.
  • Acupuncture treatment for gastrointestinal diseases within the past 1 month.
  • Participation in another clinical trial within the past 2 months.
  • Drug abuse or alcohol abuse.
  • Pregnant or breastfeeding women.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

YI Liang, Doctor contact

+86 571 86633328

liangyiwww@126.com

China4 sites
  • Hangzhou First People's Hospital

    Hangzhou, Zhejiang, 310053

    siyi zheng, Doctor, zsy980714@gmail.com

  • Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310053

  • The First Affiliated Hospital of Zhejiang Chinese Medical University

    Hangzhou, Zhejiang, 310053

  • The Third Affiliated Hospital of Zhejiang Chinese Medicinal University

    Hangzhou, Zhejiang, 310053

    Chenben Zhang, +86-18815051075, 1262243501@qq.com

Other trials in China

About this study

Official title: Efficacy Evaluation of Electroacupuncture in the Treatment of Functional Dyspepsia: A Multicenter Clinical Trial Study

Functional dyspepsia (FD) is a common disorder that causes stomach discomfort, such as fullness or pain after eating, without any visible structural disease. Acupuncture is often used to manage these symptoms. This study aims to evaluate the safety and effectiveness of electroacupuncture-a form of acupuncture that uses gentle electrical stimulation-for treating functional dyspepsia. Specifically, the trial will compare the benefits of applying electroacupuncture to points on the abdomen (local points) versus points on the arms and legs (distal points), alongside a control group receiving a sham (inactive) treatment. The goal is to determine the most effective acupuncture strategy for improving patients' digestive symptoms and overall quality of life.

Read the detailed description

Functional dyspepsia (FD) significantly impairs patients' quality of life and is often accompanied by psychological distress. While traditional acupuncture is widely used in the treatment of FD, electroacupuncture has been suggested to enhance therapeutic effects by providing continuous, standardized electrical stimulation to specific acupoints. However, the comparative effectiveness of targeting local abdominal acupoints versus distal limb acupoints remains unclear.

This multicenter randomized controlled trial is designed to investigate the physiological and clinical effects of electroacupuncture on FD. Following informed consent, participants are randomly assigned in a 1:1:1 ratio to one of three parallel arms:

Local Electroacupuncture Group: Electrical stimulation applied to selected abdominal acupoints.

Distal Electroacupuncture Group: Electrical stimulation applied to selected limb acupoints.

Control Group: Acupuncture with a sham electroacupuncture device that delivers no electrical current.

The intervention phase consists of treatments administered twice weekly for 3 weeks (totaling 6 sessions). All procedures are standardized and performed by licensed acupuncturists with a minimum of three years of clinical experience. Active groups utilize a standard electroacupuncture device to deliver the current, while the sham group is designed to maintain blinding without providing active electrical stimulation. Following the intervention phase, participants enter a 12-week follow-up period to assess the sustainability of the therapeutic effects.

By comparing local and distal stimulation strategies, this research intends to elucidate the optimal clinical application of electroacupuncture and provide evidence-based guidance for the management of functional dyspepsia.

Being tested
Electroacupuncture (Local Acupoints), Electroacupuncture (Distal Acupoints), Sham Electroacupuncture (Control)
Keywords
functional dyspepsia, electroacupuncture, Local Acupoints, Distal Acupoints

What participants receive

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

  • Electroacupuncture (Local Acupoints)Other

    Participants assigned to this intervention will receive electroacupuncture at local abdominal acupoints, including bilateral Shangwan (CV13), Zhongwan (CV12), Xiawan (CV10), Liangmen (ST21), and Tianshu (ST25). Sterile disposable acupuncture needles (0.30 × 40 mm) will be inserted vertically by licensed acupuncturists with at least three years of clinical experience to a depth of approximately 20-30 mm to elicit the Deqi sensation (such as soreness, numbness, distension, or heaviness). Two pairs of acupoints (Shangwan-Zhongwan and left Liangmen-right Liangmen) will be connected to an SDZ-V electroacupuncture device. Electrical stimulation will be applied at a frequency of 5 Hz, with current intensity adjusted to the participant's tolerance. Each treatment session will last 30 minutes and will be administered twice weekly for 3 weeks (6 sessions in total).

  • Electroacupuncture (Distal Acupoints)Other

    Participants in this group will receive electroacupuncture at distal limb acupoints, including bilateral Zusanli (ST36), Shangjuxu (ST37), Xiajuxu (ST39), and Yinlingquan (SP9). Sterile disposable acupuncture needles (0.30 × 40 mm) will be inserted by trained acupuncturists to achieve the Deqi sensation. Electrical stimulation will be applied by connecting bilateral Zusanli (ST36) and Xiajuxu (ST39) to an SDZ-V electroacupuncture device. The stimulation frequency will be set at 5 Hz, and the current intensity will be adjusted according to the participant's tolerance. Each session will last 30 minutes, administered twice weekly for 3 weeks (6 sessions in total).

  • Sham Electroacupuncture (Control)Other

    Participants in the control group will receive acupuncture at the same acupoints as the electroacupuncture groups using identical needling procedures to achieve the Deqi sensation. However, the needles will be connected to a specially designed sham electroacupuncture device that appears identical to the active SDZ-V electroacupuncture device but does not deliver electrical stimulation. Each treatment session will last 30 minutes and will be administered twice weekly for 3 weeks (6 sessions in total).

Study groups in NCT07496580
Study groupRoleWhat they receive
local electroacupuncture groupExperimentalParticipants in this group will receive electroacupuncture at local abdominal acupoints, including bilateral Shangwan (CV13), Zhongwan (CV12), Xiawan (CV10), Liangmen (ST21), and Tianshu (ST25). Sterile disposable acupuncture needles (0.30 × 40 mm) will be inserted to achieve the sensation of Deqi. Two pairs of acupoints (Shangwan-Zhongwan and left Liangmen-right Liangmen) will be connected to an electroacupuncture device delivering electrical stimulation at a frequency of 5 Hz for 30 minutes. Treatments will be administered twice per week for 3 weeks, totaling 6 sessions.
Receives: Other: Electroacupuncture (Local Acupoints)
distal electroacupuncture groupExperimentalParticipants in this group will receive electroacupuncture at distal limb acupoints, including bilateral Zusanli (ST36), Shangjuxu (ST37), Xiajuxu (ST39), and Yinlingquan (SP9). Sterile disposable acupuncture needles (0.30 × 40 mm) will be inserted to elicit the Deqi sensation. Electroacupuncture will be applied by connecting bilateral Zusanli and Xiajuxu to an electroacupuncture device with a frequency of 5 Hz for 30 minutes. Treatments will be performed twice weekly for 3 weeks, totaling 6 sessions.
Receives: Other: Electroacupuncture (Distal Acupoints)
Acupuncture with Sham Electroacupuncture Group (Control Group)Sham comparatorParticipants in the control group will receive acupuncture at the same acupoints as the electroacupuncture groups. Needles will be inserted using the same technique to elicit Deqi. However, the needles will be connected to a specially designed sham electroacupuncture device that looks identical to the real device but does not deliver electrical stimulation. Each treatment session will last 30 minutes, administered twice per week for 3 weeks, for a total of 6 sessions.
Receives: Other: Sham Electroacupuncture (Control)

What is being measured

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

  1. Overall Treatment Effect (OTE) Response Rate at Week 3

    The overall treatment effect will be assessed using a 7-point Likert scale evaluating the change in gastrointestinal symptoms compared with baseline. Participants who report "improved" or "extremely improved" will be considered responders. The response rate will be calculated as the proportion of participants achieving improvement at the end of the 3-week treatment period.

    Measured: Week 3

  2. Main Symptom Elimination Rate at Week 3

    The elimination rate of the main symptoms will be defined as the proportion of participants whose primary symptoms score is 0 (no symptoms) at week 3. In the postprandial distress syndrome (PDS) subtype, the main symptoms include postprandial fullness and/or early satiety. In the epigastric pain syndrome (EPS) subtype, the main symptoms include epigastric pain and/or burning. For participants with combined PDS and EPS, the main symptoms include both symptom categories.

    Measured: Week 3

Secondary outcomes (7)
  1. Global Overall Symptom (GOS) Score

    The Global Overall Symptom (GOS) scale will be used to assess the severity of eight dyspeptic symptoms, including epigastric pain, epigastric burning, regurgitation, postprandial fullness, nausea/vomiting, belching, early satiety, and heartburn. Each symptom is rated on a 7-point Likert scale ranging from 1 (no problem) to 7 (very severe problem). Changes in GOS scores will be evaluated over time to assess symptom improvement.

    Measured: Baseline (Week 0), Week 3, Week 7, Week 11, and Week 15

  2. Nepean Dyspepsia Index (NDI) Score

    Health-related quality of life in patients with functional dyspepsia will be evaluated using the Nepean Dyspepsia Index (NDI). The NDI quality-of-life total score ranges from a minimum of 0 to a maximum of 100, where higher scores indicate a better health-related quality of life (less impairment from dyspepsia). The scale measures the impact of dyspepsia on multiple aspects of daily life, including tension, interference with daily activities, eating/drinking, knowledge/control, and work/study. Changes in NDI scores will be assessed during treatment and follow-up.

    Measured: Baseline (Week 0), Week 3, Week 7, Week 11, and Week 15

  3. Hospital Anxiety and Depression Scale (HADS) Score

    The Hospital Anxiety and Depression Scale (HADS) will be used to assess levels of anxiety and depression in participants. The HADS consists of two subscales: Anxiety (HADS-A) and Depression (HADS-D). Each subscale score ranges from a minimum of 0 to a maximum of 21. If combined into a total score, the minimum is 0 and the maximum is 42. For both the subscales and the total score, higher scores indicate higher levels of anxiety and depression (a worse outcome). Changes in HADS scores will be evaluated to explore the psychological effects of the intervention.

    Measured: Baseline (Week 0), Week 3, Week 7, Week 11, and Week 15

  4. Expectation of Electroacupuncture Treatment

    Before treatment, participants will be asked to evaluate their expectations regarding the effectiveness of electroacupuncture using a 5-point scale (strongly agree, agree, neutral, disagree, strongly disagree) in response to the statement that electroacupuncture will significantly improve their symptoms.

    Measured: Baseline (Week 0)

  5. Blinding Assessment

    Participants will be asked to guess whether they received electroacupuncture or sham electroacupuncture after the first treatment session and after the sixth treatment session in order to assess the effectiveness of blinding.

    Measured: Baseline (after Session 1) and Week 3 (after Session 6)

  6. Treatment Adherence

    Treatment adherence will be evaluated by recording whether participants complete the scheduled treatment sessions and outcome assessments. Reasons for withdrawal, exclusion, or loss to follow-up will also be documented.

    Measured: Week 0, Week 3, and Week 15

  7. Safety Outcomes (Adverse Events)

    All adverse events occurring during the study period will be recorded and evaluated to assess the safety of electroacupuncture treatment.

    Measured: From baseline to Week 15

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 start1 Mar 2026 (estimated)
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07496580
Sponsor's protocol ID
20260305031650208
Status last verified
Mar 2026
First submitted
16 Mar 2026
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Electroacupuncture (Local Acupoints) and Electroacupuncture (Distal Acupoints) in people with Functional Dyspepsia and Electroacupuncture, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 4 sites in China.

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 11 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: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact YI Liang, Doctor (+86 571 86633328, liangyiwww@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Treatment Effect (OTE) Response Rate at Week 3 (time frame: Week 3). The study lists 2 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 27 Mar 2026.

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