Functional dyspepsia
Conditions
Interventions
Sham electroacupuncture control group:Sham electroacupuncture at healthy people ST36 (Zu Sanli) with the low-intensity current.
Electroacupuncture with low-intensity current group:Electroacupuncture at healthy people ST36 (Zu Sanli) with low-intensity current
Electroacupuncture at healthy people ST36 (Zu Sanli) with middle-intensity current:Electroacupuncture at healthy people ST36 (Zu Sanli) with middle-intensity current
Electroacupuncture at ST36 (Zu Sanli) with high-intensity current:Electroacupuncture at healthy people ST36 (Zu Sanli) with high-intensity current
Optimal current electroacupuncture group:Optimal intensity current electroacupuncture at functional dyspepsia patients' ST36 (Zu Sanli) point
Sham electroacupuncture control group:Optimal intensity current sham electroacupuncture at functional dyspepsia patients' ST36 (Zu Sanli) point
Sponsors
Huashan Hospital affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: The inclusion criteria of the first research are summarized as follows: 1. Male or female healthy individuals aged 18 to 65 years; 2. Normal gastrointestinal tract structure confirmed by gastroscopy and a negative C13 urea breath test for Helicobacter pylori; 3. Individuals who maintained a regular diet two weeks before enrollment (no self-reported irregular diet causing excessive hunger or satiety). 4. Participants who understood the informed consent document and provided written consent voluntarily before randomization. The specific disease and subtype definitions are detailed in the second program, and the brief exclusion criteria are as follows: 1. Diagnostic criteria for IV functional dyspepsia and the definition of PDS or EPS subtypes. 2. Male or female patients between 18 and 65 years old (including 18 and 65 years old). 3. Patients who voluntarily discontinue all medications and interventions for functional dyspepsia within 7 days before the initial examination. 4. Patients with negative results for Helicobacter pylori, or those who test positive for Helicobacter pylori but have completed the course of drug treatment to eradicate Helicobacter pylori, and have stopped taking medication for more than 2 months; 5. Voluntarily discontinue the use of various drugs and intervention methods for treating functional dyspepsia within 7 days before the initial examination; 6. Patients who voluntarily sign the informed consent form for this subject before randomization.
Exclusion criteria
Exclusion criteria: The detailed exclusion criteria in the first program and the brief exclusion criteria are as follows: 1. Unconscious or unable to express subjective discomfort symptoms; 2. Mental health conditions (e.g., neurological or psychiatric disorders) or receiving treatment that would interfere with study procedures, at the discretion of the study team; 3. Personal history of gastrointestinal surgery. 4. Individuals with obvious signs of irritable bowel syndrome or gastrointestinal dysfunction in the past 6 months (e.g., constipation, diarrhea symptoms, fullness and discomfort after meals, etc.) 5. Administration of acid suppressants or gastric mucosa protectants, antibiotics, or probiotics within 2 weeks before enrollment; 6. Severe diseases of other organs that may interfere with study procedures (e.g., heart, liver, or kidney disease, infectious diseases, current cancer diagnosis, etc.), at the discretion of the study team; 7. Individuals who cannot accept acupuncture intervention, have an allergic constitution, or are allergic to medical supplies; 8. Individuals with medical conditions that may interfere with study procedures (e.g., limb defects, clotting disorders or leukopenia, pacemakers, epilepsy, or patients currently on anticoagulant therapy); 9. Pregnant or lactating women; 10. Individuals who had participated in another related research that may interfere with this study procedures. The detailed exclusion criteria in the second program and the brief exclusion criteria are as follows: 1. Unconscious or unable to express subjective discomfort symptoms; 2. Mental health conditions (e.g., neurological or psychiatric disorders) or receiving treatment that would interfere with study procedures, at the discretion of the study team; 3. Personal history of gastrointestinal surgery (e.g., tumorectomy, truncal vagotomy), at the discretion of the study team; 4. Individuals with obvious signs of irritable bowel syndrome or gastrointestinal dysfunction in the past 6 months (e.g., constipation, diarrhea symptoms), at the discretion of the study team; 5. Administration of acid suppressants or gastric mucosa protectants, antibiotics, or probiotics within 2 weeks before enrollment; 6. Severe diseases of other organs that may interfere with study procedures (e.g., heart, liver, or kidney disease, infectious diseases, current cancer diagnosis, etc.), at the discretion of the study team; 7. Individuals who cannot accept acupuncture intervention, have an allergic constitution, or are allergic to medical supplies; 8. Individuals with medical conditions that may interfere with study procedures (e.g., limb defects, clotting disorders or leukopenia, pacemakers, epilepsy, or patients currently on anticoagulant therapy); 9. Pregnant or lactating women; 10. Individuals who had participated in another related research that may interfere with this study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative rate of change of the mean amplitude of gastric electricity in the immediate post-intervention;Nepean Dyspepsia Index (Chinese Version); | — |
Secondary
| Measure | Time frame |
|---|---|
| Average frequency;Dominant frequency;Dominant power ration;Reaction area;Mandarin version of the Leeds Dyspepsia Questionnaire;Average frequency;The average amplitude of the EGG waveform;Dominant frequency;Percentage of EGG rhythm disturbances;Slow wave frequency instability coefficient;Percentage of normal slow wave;The power ratio after/before a meal;Reaction area; | — |
Countries
China
Contacts
Public ContactNianhong Wang
Huashan Hospital affiliated to Fudan University
Outcome results
None listed