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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Hangzhou First People's Hospital
RECRUITING
Hangzhou
Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine
RECRUITING
Hangzhou
The First Affiliated Hospital of Zhejiang Chinese Medical University
RECRUITING
Hangzhou
The Third Affiliated Hospital of Zhejiang Chinese Medicinal University
RECRUITING
Hangzhou
Contact Information
Primary
Yi Liang, Doctor
liangyiwww@126.com
+86 571 86633328
Time Frame
Start Date: 2025-04-13
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 180
Treatments
Experimental: 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.
Experimental: 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.
Sham_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Yi Liang
Collaborators: Zhejiang Provincial Department of Science and Technology

This content was sourced from clinicaltrials.gov