Trials / Unknown
UnknownNCT04668534
Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Functional Dyspepsia
Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Functional Dyspepsia: a Randomized Controlled Trial
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- Air Force Military Medical University, China · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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). Given the lack of information related to its pathophysiology, the treatment is largely empirical and of limited efficacy. Previous small study showed therapeutic potential of transcutaneous auricular vagal nerve stimulation (taVNS) for FD. This study aims to investigate whether taVNS can improve the dyspeptic symptoms of patients with FD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | taVNS 10 | Patients were given taVNS (by Xi'an Bashui Health Technology Co., Ltd) thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s "on" periods and 30s "off" periods; frequency: 10 Hz; current intensity: minimal pain threshold; pulse width: 500 μs) |
| DEVICE | taVNS 25 | Patients were given taVNS (by Xi'an Bashui Health Technology Co., Ltd) thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s "on" periods and 30s "off" periods; frequency: 25 Hz; current intensity: minimal pain threshold; pulse width: 500 μs) |
| DEVICE | Control | Patients were given taVNS (by Xi'an Bashui Health Technology Co., Ltd) thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s "on" periods and 30s "off" periods; frequency: 10 Hz; current intensity: minimal pain threshold; pulse width: 500 μs) |
Timeline
- Start date
- 2020-11-01
- Primary completion
- 2021-12-28
- Completion
- 2022-03-28
- First posted
- 2020-12-16
- Last updated
- 2020-12-16
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04668534. Inclusion in this directory is not an endorsement.