Evaluation of the Efficacy of Electroacupuncture in the Treatment of Functional Dyspepsia

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.

Conditions

• Functional Dyspepsia

Interventions

OTHER

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

OTHER

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.

OTHER

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

Sponsors & Collaborators

• Zhejiang Provincial Department of Science and Technology

  collaborator UNKNOWN

• Yi Liang

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-13

Primary Completion

2026-09-30

Completion

2026-09-30

Countries

• China

Study Locations