Evaluation of the Efficacy of Electroacupuncture in the Treatment of Functional Dyspepsia
NCT ID: NCT06618911
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
180 participants
INTERVENTIONAL
2025-04-13
2026-09-30
Brief Summary
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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:
* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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5 Hz Electroacupuncture Group
Participants 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.
5 Hz electroacupuncture
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
100 Hz Electroacupuncture Group
Participants 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.
100 Hz electroacupuncture
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
Sham Electroacupuncture (Control) Group
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.
Sham electroacupuncture
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.
Interventions
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5 Hz electroacupuncture
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 electroacupuncture
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 electroacupuncture
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
Eligibility Criteria
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Inclusion 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Zhejiang Provincial Department of Science and Technology
UNKNOWN
Yi Liang
OTHER
Responsible Party
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Yi Liang
Research Fellow
Locations
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The Third Affiliated Hospital of Zhejiang Chinese Medicinal University
Hangzhou, None Selected, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20240903074110247
Identifier Type: -
Identifier Source: org_study_id
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