Electroacupuncture to relieve functional dyspepsia symptoms
Evaluation of the Efficacy of Electroacupuncture in the Treatment of Functional Dyspepsia: A Pilot Study
This trial will test whether two electroacupuncture frequencies (5 Hz and 100 Hz) help adults aged 18–80 with functional dyspepsia feel better compared with a sham procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The Third Affiliated hospital of Zhejiang Chinese Medical University Academic / other |
| Locations | 4 sites (Hangzhou, None Selected and 3 other locations) |
| Trial ID | NCT06618911 on ClinicalTrials.gov |
What this trial studies
Adults diagnosed with functional dyspepsia by Rome IV criteria will be assigned to receive 5 Hz electroacupuncture, 100 Hz electroacupuncture, or sham electroacupuncture and followed for symptom changes. Treatments are delivered at specific acupoints according to the study protocol and responses will be compared overall and by FD subtype (postprandial distress syndrome and epigastric pain syndrome). Key eligibility requirements include normal endoscopy within the past year and exclusion of patients with H. pylori infection, recent conflicting medication use, or serious comorbidities. The trial aims to determine whether either frequency produces greater symptom relief than sham and whether frequency effects differ between FD subtypes.
Who should consider this trial
Good fit: Adults aged 18–80 with a Rome IV diagnosis of functional dyspepsia, recent normal endoscopy, no recent acupuncture, and no conflicting trial participation are the intended candidates.
Not a fit: Patients with structural GI disease, active H. pylori infection, recent use of prokinetics/PPIs/antacids/antidepressants, prior gastrointestinal surgery (where excluded), or serious comorbid conditions are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, electroacupuncture could provide a non-drug option to reduce dyspepsia symptoms and improve patients' quality of life.
How similar studies have performed: Some smaller trials and meta-analyses have reported symptom improvements with acupuncture or electroacupuncture for dyspepsia, but results are mixed and high-quality large randomized evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Hangzhou, None Selected and 3 other locations
- The Third Affiliated Hospital of Zhejiang Chinese Medicinal University — Hangzhou, None Selected, China (Recruiting)
- Hangzhou First People's Hospital — Hangzhou, Zhejiang, China (Recruiting)
- Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
- The First Affiliated Hospital of Zhejiang Chinese Medical University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Yi Liang, Doctor
- Email: liangyiwww@126.com
- Phone: +86 571 86633328
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.