Actively Recruiting
Study on the Efficacy and Mechanism of Auricular Stimulation for Functional Dyspepsia With Insomnia Based on Brain Function: A Single-center, Randomized Controlled Clinical Trial
Led by The First Affiliated Hospital of Zhejiang Chinese Medical University · Updated on 2026-03-02
176
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Functional dyspepsia (FD) is a long-lasting disorder affecting the connection between the gut and brain, causing uncomfortable upper stomach symptoms. It is classified into postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS), often overlapping. FD is common worldwide, significantly impacting quality of life and creating economic challenges. Sleep problems, anxiety, and depression frequently occur alongside FD and relate to symptom severity and recurrence. Current treatments like prokinetic agents and acid-suppressive therapy may have limited effects and side effects. This research studies auricular acupoint stimulation to evaluate its safety and effectiveness in FD patients with sleep disorders, also exploring brain function and autonomic and gut-related mechanisms.
CONDITIONS
Brief Title
Auricular Stimulation for Functional Dyspepsia With Insomnia: Efficacy and Mechanisms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet the diagnostic criteria for functional dyspepsia and sleep disorders
- Pittsburgh Sleep Quality Index score of 7 or higher
- Right-handed, aged 18 years or above
- No use of antibiotics, microbiota-related products, or drugs affecting gastrointestinal flora or sleep quality for at least 2 weeks prior to enrollment
- Voluntary participation with signed informed consent
You will not qualify if you...
- Secondary insomnia caused by drugs or other diseases
- Comorbidity with other psychiatric disorders or severe heart, liver, kidney, or other systemic diseases
- Previous treatment with auricular therapy or participation in other clinical trials within the past 6 months
- Contraindications to auricular therapy such as allergy or damage at the ear application site
- Pregnant or breastfeeding women
- History of cranial organic lesions, cranial surgery, or severe trauma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants receive auricular acupressure by pressing ear seeds containing Vaccaria seeds on specific points of the ear three times daily for two weeks. They visit the hospital once a week to replace the ear seeds.
2 visits (in-person) during treatment
Duration - 6 weeks
Participants are monitored for treatment effects and symptoms related to functional dyspepsia and insomnia over an additional 6 weeks after treatment ends.
Visits at 4 weeks and 6 weeks after treatment
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, China, 310006
Actively Recruiting
Research Team
J
JianNong Wu, doctor
M
mengyuan shen, doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here