Clinical Efficacy Oberservation of taVNS in the Treatment of Functional Dyspepsia and Its Mechanism of Brain-Gut Axis: a Randomized Controlled Trial.
- Conditions
- functional dyspepsia
- Registration Number
- ITMCTR2000003472
- Lead Sponsor
- Guang'anmen Hospital, China Academy of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1) Aged >= 21 years old, <= 65 years old;
2) Meet FD diagnosis and FD subtype criteria;
3) Those who participate voluntarily and sign the informed consent;
Note: Only patients who meet the above four conditions can be included in this study.
1) Currently taking prokinetic agents, such as anticholinergic or dopaminergic drugs;
2) Organic diseases of the digestive tract, or systemic diseases affecting the dynamics of the digestive tract (e.g. hyperthyroidism, diabetes, chronic renal insufficiency, mental and neurological diseases, etc.);
3) Patients who are unconscious, have a history of mental illness or are suffering from mental illness;
4) Diabetes, malignant tumors and other serious wasting diseases;
5) Patients with cardiovascular and abnormal hepatorenal function;
6) A history of gastrointestinal surgery;
7) Planned pregnancy, pregnant women and lactation patients;
8) Allergic to skin contact;
9) Severe ear armour skin lesion and lack of eardrum.
Note: Exclusions are made if any of the above conditions are met.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of overall symptom efficacy;cerebral function monitor;Evaluation of overall symptom efficacy;GSA;
- Secondary Outcome Measures
Name Time Method life quality evaluation;Psychosocial efficacy rating;