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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Functional Dyspepsia

In brief

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.

Key facts

Study ID

NCT06618911

Run by

Yi Liang

People needed

180

Starts

2025-04-13

Expected to finish

2026-09-30

Last updated by the study team

2025-08-29

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Presence of serious or malignant diseases (e.g., cirrhosis, heart failure, 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.

Where it is running

• The Third Affiliated Hospital of Zhejiang Chinese Medicinal University — Hangzhou, None Selected, China (enrolling)
• Hangzhou First People's Hospital — Hangzhou, Zhejiang, China (enrolling)
• Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)
• The First Affiliated Hospital of Zhejiang Chinese Medical University — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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