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Functional DyspepsiaNCT06618911

Evaluation of the Efficacy of Electroacupuncture in the Treatment of Functional Dyspepsia

A study testing 5 Hz electroacupuncture and 100 Hz electroacupuncture in people with Functional Dyspepsia, run by Yi Liang at 4 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Brief Summary Template for the Study: The goal of this clinical trial is to evaluate whether electroacupuncture can treat functional dyspepsia (FD) in adult participants aged 18 to 65 years, including both males and females, who have been diagnosed with functional dyspepsia based on the Rome IV criteria. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Functional Dyspepsia
What is being tested?
5 Hz electroacupuncture and 100 Hz electroacupuncture
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
4 sitesChina
Study dates
13 Apr 2025to 30 Sep 2026
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

  • Diagnosed with functional dyspepsia based on Rome IV diagnostic criteria.
  • Aged 18 to 80 years, inclusive, with no gender restrictions.
  • Normal endoscopy results within the past year, showing no structural explanation for symptoms.
  • No acupuncture treatment in the last month.
  • Not participating in any other clinical trials in the past 2 months.
  • Able to understand and provide informed consent.

Who cannot join

  • Presence of serious or malignant diseases (e.g., cirrhosis, heart failure, gastrointestinal tumors) that could explain dyspepsia symptoms.
  • Positive for Helicobacter pylori infection based on C-13 urea breath test or gastric biopsy.
  • History of gastrointestinal surgery (excluding laparoscopic and other minimally invasive surgeries).
  • Recent use (within 2 weeks) of medications affecting dyspepsia, including prokinetics, proton pump inhibitors, antacids, or antidepressants.
  • Presence of severe mental or physical conditions, such as dementia or illiteracy, that could interfere with study participation.
  • Severe coagulation disorders.
  • Substance abuse or alcohol dependence.
  • 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, 4 recruiting
  • The Third Affiliated Hospital of Zhejiang Chinese Medicinal University

    Hangzhou, None Selected, 310053

    Chenben Zhang, +86-18815051075, zsy980714@gmail.com

    Recruiting
  • Hangzhou First People's Hospital

    Hangzhou, Zhejiang, 310053

    siyi zheng, +86-15990088547, zsy980714@gmail.com

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

    Hangzhou, Zhejiang, 310053

    siyi zheng, +86-15990088547, zsy980714@gmail.com

    Recruiting
  • The First Affiliated Hospital of Zhejiang Chinese Medical University

    Hangzhou, Zhejiang, 310053

    Xiaojing Wang, +86-19857011126, 1041073233@qq.com

    Recruiting

Other trials in China

About this study

Official title: Evaluation of the Efficacy of Electroacupuncture in the Treatment of Functional Dyspepsia: A Pilot Study

Brief Summary Template for the Study:

The goal of this clinical trial is to evaluate whether electroacupuncture can treat functional dyspepsia (FD) in adult participants aged 18 to 65 years, including both males and females, who have been diagnosed with functional dyspepsia based on the Rome IV criteria. The main questions it aims to answer are:

Read more
  • Does 5 Hz electroacupuncture improve symptoms in functional dyspepsia patients?
  • Does 100 Hz electroacupuncture improve symptoms in functional dyspepsia patients?
  • Are there differences in the efficacy between 5 Hz and 100 Hz electroacupuncture in treating functional dyspepsia and its subtypes (PDS and EPS)?

Researchers will compare the effects of 5 Hz electroacupuncture, 100 Hz electroacupuncture, and sham electroacupuncture to determine which approach provides more significant symptom relief and whether different frequencies have varying impacts on FD subtypes.

Participants will:

  • Receive electroacupuncture treatment at specific acupoints (such as Liangmen, Tianshu, Zusanli, and Xiajuxu) for 30-minute sessions, 3 times a week for 4 weeks.
  • Be randomly assigned to one of the following groups: 5 Hz electroacupuncture, 100 Hz electroacupuncture, or sham electroacupuncture (control).
  • Have their functional dyspepsia symptoms, quality of life, and any adverse effects monitored and evaluated throughout the study.
Being tested
5 Hz electroacupuncture, Sham electroacupuncture, 100 Hz electroacupuncture
Keywords
electroacupuncture, functional dyspepsia

What participants receive

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

  • 5 Hz electroacupunctureOther

    Intervention Description:

    The intervention in this study involves the use of electroacupuncture (EA), a combination of traditional acupuncture and electrical stimulation.

    Acupoints Selection: Electroacupuncture will be performed at specific acupoints associated with the stomach and digestive system. The local acupoints chosen are Liangmen (ST21) and Tianshu (ST25), while the distal acupoints are Zusanli (ST36) and Xiajuxu (ST39). This selection is based on Traditional Chinese Medicine (TCM) principles for treating functional dyspepsia.

    Frequency: 5 Hz

  • Sham electroacupunctureOther

    Participants will receive sham electroacupuncture at the same acupoints: Liangmen (ST21), Tianshu (ST25), Zusanli (ST36), and Xiajuxu (ST39). Non-penetrating needles will touch the skin but will not induce \"deqi.\" A sham electroacupuncture device (no actual current) will be used, and treatment will last 30 minutes per session. Participants will receive 3 sessions per week for 4 weeks (total: 12 sessions). This arm serves as a placebo control to evaluate the true effect of electroacupuncture.

  • 100 Hz electroacupunctureOther

    Intervention Description:

    The intervention in this study involves the use of electroacupuncture (EA), a combination of traditional acupuncture and electrical stimulation.

    Acupoints Selection: Electroacupuncture will be performed at specific acupoints associated with the stomach and digestive system. The local acupoints chosen are Liangmen (ST21) and Tianshu (ST25), while the distal acupoints are Zusanli (ST36) and Xiajuxu (ST39). This selection is based on Traditional Chinese Medicine (TCM) principles for treating functional dyspepsia.

    Frequency: 100 Hz

Study groups in NCT06618911
Study groupRoleWhat they receive
5 Hz Electroacupuncture GroupExperimentalParticipants will receive electroacupuncture at a frequency of 5 Hz at four acupoints: Liangmen (ST21) and Tianshu (ST25) (local acupoints), and Zusanli (ST36) and Xiajuxu (ST39) (distal acupoints). Disposable needles will be inserted until the "deqi" sensation is achieved. The needles will be connected to an SDZ-IIB electroacupuncture device set at 5 Hz, with stimulation lasting 30 minutes per session. Participants will receive 3 sessions per week for 4 weeks (total: 12 sessions). This group aims to evaluate the efficacy of low-frequency electroacupuncture for treating functional dyspepsia.
Receives: Other: 5 Hz electroacupuncture
100 Hz Electroacupuncture GroupExperimentalParticipants will receive electroacupuncture at a frequency of 100 Hz at the same four acupoints: Liangmen (ST21), Tianshu (ST25), Zusanli (ST36), and Xiajuxu (ST39). Needles will be inserted to induce the "deqi" sensation and connected to an SDZ-IIB device set at 100 Hz, with stimulation lasting 30 minutes per session. Participants will receive 3 sessions per week for 4 weeks (total: 12 sessions). This group assesses the efficacy of high-frequency electroacupuncture for functional dyspepsia.
Receives: Other: 100 Hz electroacupuncture
Sham Electroacupuncture (Control) GroupSham comparatorParticipants will receive sham electroacupuncture at the same acupoints: Liangmen (ST21), Tianshu (ST25), Zusanli (ST36), and Xiajuxu (ST39). Non-penetrating needles will touch the skin but will not induce "deqi." A sham electroacupuncture device (no actual current) will be used, and treatment will last 30 minutes per session. Participants will receive 3 sessions per week for 4 weeks (total: 12 sessions). This arm serves as a placebo control to evaluate the true effect of electroacupuncture.
Receives: Other: Sham electroacupuncture

What is being measured

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

  1. Symptom Improvement Rate at Week 4

    The primary outcome is the percentage of participants experiencing symptom improvement using the 7-point Likert scale for Overall Treatment Effect (OTE).

    The Overall Treatment Effect (OTE) questionnaire was categorized as "extremely worse than baseline," "worse than baseline," "slightly worse than baseline," "no change," "slightly improved than baseline," "improved than baseline," or "much improved than baseline."

    Participants will rate their symptom severity compared to baseline, and those reporting "improved than baseline" or "much improved than baseline"will be considered responders.

    The primary outcome will assess the efficacy of 5 Hz and 100 Hz electroacupuncture compared to sham treatment.

    Measured: 4 weeks after the start of treatment.

  2. Main Symptom Resolution Rate at Week 4

    The second primary outcome is the rate of complete resolution of the main symptoms of functional dyspepsia at week 4. For Postprandial Distress Syndrome (PDS), the primary symptoms are postprandial fullness and early satiety; for Epigastric Pain Syndrome (EPS), the main symptoms are epigastric pain and burning. Complete resolution is defined as a score of 0 for the respective main symptoms on a validated symptom severity scale.

    The severity of each symptom is divided into: no symptoms (0 points), mild (1 point), moderate (2 points), and severe (3 points).

    The outcome will compare the resolution rates between the 5 Hz, 100 Hz, and sham electroacupuncture groups.

    Measured: 4 weeks after the start of treatment.

Secondary outcomes (5)
  1. Global Overall Symptom (GOS) Score Change

    The Global Overall Symptom (GOS) score assesses eight symptoms associated with functional dyspepsia (e.g., epigastric pain, burning, fullness, early satiety, nausea, bloating). Scores range from 1 (no problem) to 7 (very severe problem).

    Scoring is as follows: 1 = no problem (no symptoms); 2 = minimal problem (can be easily ignored); 3 = mild problem (can be ignored with effort); 4 = moderate problem (cannot be ignored, but does not interfere with daily activities); 5 = moderately severe problem (cannot be ignored, occasionally limits daily activities); 6 = severe problem (cannot be ignored, often limits concentration on daily activities); 7 = very severe problem (cannot be ignored, severely limits daily activities.

    The change from baseline to week 4 will be compared between the 5 Hz, 100 Hz, and sham electroacupuncture groups.

    Measured: Baseline to Week 4

  2. Nepean Dyspepsia Index (NDI) Score Change

    The Nepean Dyspepsia Index (NDI) evaluates the impact of dyspepsia on patients \'quality of life across five domains (e.g., tension, interference with daily activities). The change in NDI score from baseline to week 4 will be used to assess the efficacy of the interventions in improving quality of life.

    Higher scores on the Nepean Dyspepsia Index (NDI) indicate more severe symptoms

    Measured: Baseline to Week 4

  3. Hospital Anxiety and Depression Scale (HADS) Score Change

    The Hospital Anxiety and Depression Scale (HADS) measures levels of anxiety and depression, which are often associated with functional dyspepsia. Changes in HADS scores from baseline to week 4 will be evaluated to determine if electroacupuncture has an impact on emotional well-being.

    The scores of anxiety and depression subscales are divided into: 0-7 points for no symptoms; 8-10 points for suspected presence; 11-21 points for definite presence; When scoring, 8 points is the starting point, that is, both suspected and symptomatic are positive.

    Measured: Baseline to Week 4

  4. Treatment Expectation Score

    Participants\' expectations regarding the effectiveness of electroacupuncture will be assessed using a 5-point Likert scale (e.g., strongly agree to strongly disagree) prior to the first treatment. This outcome will be used to determine the role of treatment expectations in the perceived efficacy of electroacupuncture.

    Measured: Prior to the first treatment (Baseline)

  5. Blind evaluation

    Participants perception of whether they received real or sham electroacupuncture will be assessed after the 1st and 6th treatment sessions to evaluate the effectiveness of blinding in the sham group.

    Measured: immediately after 1st and 6th treatment sessions

Timeline

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

  1. First posted1 Oct 2024
  2. Study start13 Apr 2025
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (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
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06618911
Sponsor's protocol ID
20240903074110247
Status last verified
Aug 2025
First submitted
24 Sep 2024
Last updated
29 Aug 2025
Results posted
No
Data monitoring committee
Yes
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 5 Hz electroacupuncture and 100 Hz electroacupuncture in people with Functional Dyspepsia, run by Yi Liang 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 29 Aug 2025. 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?

Symptom Improvement Rate at Week 4 (time frame: 4 weeks after the start of treatment.). 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 29 Aug 2025.

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