funtional dyspepsia
Conditions
Interventions
Vagus stimulus group:taVNS
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients who meet the Rome IV diagnosis standard of FD; 2. Major symptom score above II; 3. No organic diseases such as chronic gastritis with erosion, ulcer, tumor can be observed under gastroscope within 6 months,no helicobacter pylori(Hp) infection; 4. Males and females age between 18 and 65 years; 5. No metal implants, no claustrophobia, no contraindication for magnetic resonance examination; 6. Agree to participate in the clinical study and sign informed consent,have a certain level of education to complete scales such as NDSI,HAMA,HAMD; Patients who match the criterion above simultaneously will be included.
Exclusion criteria
Exclusion criteria: 1. Patients who have overlap syndrome combined with gastroesophageal reflux disease or irritable bowel syndrome; Patients infected by helicobacter pylori; 2. Patients who have severe primary diseases in heart, liver, lung, kidney, blood; Patients who have hypertension,diabetes ,hyperthyreosis or other systemic disease; 3. Patients who with severe depression or anxiety(score more than 20 in HAMD or at lease 14 in HAMD); Those have other serious mental disorders;recent users of antidepressants; 4. Patients with history of alcoholic or drug abuse,having a history of mental disorder or dementia; 5. Patients who have allergic constitution or known to be allergic to skin preparation in this trial,or those who have injury or inflammation in the area to be treated; 6. Women during pregnancy,menstruation or breast-feeding; 7. Recent users of anticholinergic,non-steroidal anti-inflammatory drug,Hormone drugs or patients who are taking drug of anticholinergics,antispasmodic,prokinetic or antidepressants; 8. Patients who are involved in other trials within 6 months; 9. Patients whose symptoms of dyspeptic disappeared or alleviated spontaneously in two-week observation period. Patients who meet one or more of them will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Symptom Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| SF-36 Health Survey Scale;Nepean Dyspepsia Index;Hamilton Anxiety and Depression Scale;Heart Rate Variability;Amplitude of Low Frequency Fluctuatio (ALFF);Rregional Homogeneit(ReHo);Brain Functional Connectivity Analysis;Fanctional Network Analysis;Arterial Spin Labeling (ASL);gastrin (GAS);motilin (MOT);5-hydroxytryptamine (5-HT);Ghrelin;cholecystokinin-octopeptide(CCK-8); | — |
Countries
China
Contacts
Public ContactYe Yongsong,Huang Suiping
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed