Status:
UNKNOWN
Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Functional Dyspepsia
Lead Sponsor:
Air Force Military Medical University, China
Conditions:
Functional Dyspepsia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Patients with dyspeptic symptoms vary from 10% to 20% globally. Up to 70% of patients with dyspepsia who undergo endoscopy have unremarkable examination and are diagnosed with functional dyspepsia (FD...
Eligibility Criteria
Inclusion
- 18-65 years old
- Patients who met the Rome IV diagnostic criteria of FD
- Moderate to severe FD (functional dyspepsia symptom diary ≥10)
- Normal upper endoscopy and abdominal ultrasonography within one year.
Exclusion
- Injury or inflammation on the ear
- Asthma or COPD not under control
- History of cardiac pacemaker planting or other medical digital devices
- History of VNS treatment
- Patients with local or systemic diseases which may cause dyspeptic symptoms:
- Known active peptic ulcer, cholecystitis, gallstone, gastrointestinal obstruction, gastroparesis, and etc.; Known acute or chronic injury of liver or kidney; Obvious hematological abnormality, or endocrine and metabolic diseases; Known malignancy; Obvious cardiovascular or cerebrovascular diseases (such as coronary heart disease, arrhythmia, cerebral infarction and etc.; Other conditions which may be associated with dyspeptic symptoms (such as NSAIDs associated dyspepsia)
- Patients with serious mental disorders or tendency to suicide
- Pregnancy or lactic women
- Inability to give informed consent
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 28 2022
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04668534
Start Date
November 1 2020
End Date
March 28 2022
Last Update
December 16 2020
Active Locations (3)
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1
Lanzhou University Second Hospital
Lanzhou, Gansu, China
2
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China, 710032
3
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China