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Efficacy Evaluation of Electroacupuncture in the Treatment of Functional Dyspepsia 105
Clinical Trial NCT07496580 is an interventional study for Functional Dyspepsia, Electroacupuncture and is currently not yet recruiting. Enrollment is planned to begin on March 1, 2026 and continue until the study accrues 105 participants. Led by The Third Affiliated hospital of Zhejiang Chinese Medical University, this study is expected to complete by December 31, 2027. The latest data from ClinicalTrials.gov was last updated on March 27, 2026.
Brief 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. 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 compa...Show More
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 acup...Show More
Official Title
Efficacy Evaluation of Electroacupuncture in the Treatment of Functional Dyspepsia: A Multicenter Clinical Trial Study
Conditions
Functional DyspepsiaElectroacupunctureOther Study IDs
- 20260305031650208
NCT ID Number
Start Date (Actual)
2026-03-01
Last Update Posted
2026-03-27
Completion Date (Estimated)
2027-12-31
Enrollment (Estimated)
105
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
functional dyspepsia
electroacupuncture
Local Acupoints
Distal Acupoints
electroacupuncture
Local Acupoints
Distal Acupoints
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Experimentallocal electroacupuncture group Participants 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 d...Show More | Electroacupuncture (Local Acupoints) 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 ...Show More |
Experimentaldistal electroacupuncture group 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 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 3...Show More | Electroacupuncture (Distal Acupoints) 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 elect...Show More |
Sham ComparatorAcupuncture with Sham Electroacupuncture Group (Control Group) Participants 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 tw...Show More | Sham Electroacupuncture (Control) 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 las...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | Week 3 |
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. | Week 3 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | Baseline (Week 0), Week 3, Week 7, Week 11, and Week 15 |
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. | Baseline (Week 0), Week 3, Week 7, Week 11, and Week 15 |
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. | Baseline (Week 0), Week 3, Week 7, Week 11, and Week 15 |
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. | Baseline (Week 0) |
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. | Baseline (after Session 1) and Week 3 (after Session 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. | Week 0, Week 3, and Week 15 |
Safety Outcomes (Adverse Events) | All adverse events occurring during the study period will be recorded and evaluated to assess the safety of electroacupuncture treatment. | From baseline to Week 15 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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.
- 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.
The Third Affiliated hospital of Zhejiang Chinese Medical UniversityStudy Responsible Party
Yi Liang, Principal Investigator, Chief TCM Physician, The Third Affiliated hospital of Zhejiang Chinese Medical University
Study Central Contact
Contact: YI Liang, Doctor, +86 571 86633328, [email protected]
4 Study Locations in 1 Countries
Zhejiang
Hangzhou First People's Hospital, Hangzhou, Zhejiang, 310053, China
siyi zheng, Doctor, Contact, [email protected]
Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310053, China
The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, 310053, China
The Third Affiliated Hospital of Zhejiang Chinese Medicinal University, Hangzhou, Zhejiang, 310053, China
Chenben Zhang, Contact, +86-18815051075, [email protected]