Clinical trial NCT06618911: Evaluation of the Efficacy of Electroacupuncture in the Treatment of Functional Dyspepsia
Official title: Evaluation of the Efficacy of Electroacupuncture in the Treatment of Functional Dyspepsia: a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Functional Dyspepsia
Keywords: electroacupuncture
functional dyspepsia
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
Collaborators: name: Zhejiang Provincial Department of Science and Technology
First posted: 2024-10-01
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

* Diagnosed with functional dyspepsia based on Rome IV diagnostic criteria.
* Aged 18 to 65 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:

* Presence of serious or malignant diseases (e.g., cirrhosis, heart failure, gastrointestinal tumors) that could explain dyspepsia symptoms.
* Chronic atrophic gastritis detected in endoscopy results.
* Positive for Helicobacter pylori infection based on C-13 urea breath test or gastric biopsy.
* History of gastrointestinal surgery.
* 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.

Primary outcomes:
measure: Symptom Improvement Rate at Week 4
timeFrame: 4 weeks after the start of treatment.
measure: Main Symptom Resolution Rate at Week 4
timeFrame: 4 weeks after the start of treatment.
Secondary outcomes:
measure: Global Overall Symptom (GOS) Score Change
timeFrame: Baseline to Week 4
measure: Nepean Dyspepsia Index (NDI) Score Change
timeFrame: Baseline to Week 4
measure: Hospital Anxiety and Depression Scale (HADS) Score Change
timeFrame: Baseline to Week 4
measure: Treatment Expectation Score
timeFrame: Prior to the first treatment (Baseline)
measure: Blind evaluation
timeFrame: immediately after 1st and 6th treatment sessions
Other outcomes:
measure: Subgroup Analysis of Symptom Improvement by FD Subtypes (PDS vs. EPS)
timeFrame: At Week 4
Locations:
city: Hangzhou
country: China
facility: the Ethics Board of The Third Affiliated Hospital of Zhejiang Chinese Medicinal University
state: None Selected
Study officials:
References: