Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06618911

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

Led by Yi Liang · Updated on 2025-08-29

180

Participants Needed

4

Research Sites

76 weeks

Total Duration

On this page

Sponsors

Y

Yi Liang

Lead Sponsor

Z

Zhejiang University of Science and Technology

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • Presence of serious or malignant diseases such as cirrhosis, heart failure, or gastrointestinal tumors that could explain dyspepsia symptoms.
  • 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.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 4 locations

1

The Third Affiliated Hospital of Zhejiang Chinese Medicinal University

Hangzhou, None Selected, China, 310053

Actively Recruiting

2

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China, 310053

Actively Recruiting

3

Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310053

Actively Recruiting

4

The First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China, 310053

Actively Recruiting

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Research Team

Y

Yi Liang, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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