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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04706871
Other study ID # taVNS-FD-2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2018
Est. completion date January 1, 2020

Study information

Verified date January 2021
Source Beijing Tongren Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objective: To observe the effect of the treatment of transcutaneous auricular vagus nerve stimulation (taVNS) for the functional dyspepsia (FD). Methods: We accrued 94 patients at Beijing TongRen Hospital. All treatments were self-administered by the patients at home after training at the hospital. Patients completed questionnaires at baseline and after 4 weeks, 8 weeks, 12 weeks. The FD Symptoms Index, Functional Dyspepsia Quality of Life Scale (FDDQL), Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD), and Self-Depression Rating Scale (SDS) were performed to evaluate the therapeutic effects. A difference of P < 0.05 was considered statistically significant.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date January 1, 2020
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 1. Age >=18 and Age <=65. 2. Clinical diagnosis of functional dyspepsia. Exclusion Criteria: - 1. History of depression, tumors, thyroid disease, diabetes, cardiac diseases. 2. History of gastrointestinal surgery. 3. Pregnant or lactating women.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
taVNS
taVNS was applied using a Huatuo stimulator (SDZ-IIB) developed by Suzhou manufacture of Medical Device and Material. Stimulation parameters was 1 mA of electrical current at a frequency of 30 Hz with pulse duration = 1 ms, for 30min, administered twice daily. The two electrodes were placed on the cymba conchae and concha around the left ear.
tnVNS
tnVNS was applied using a Huatuo stimulator (SDZ-IIB) developed by Suzhou manufacture of Medical Device and Material. Stimulation parameters was 1 mA of electrical current at a frequency of 30 Hz with pulse duration = 1 ms, for 30min, administered twice daily. The two electrodes were placed on the antihelix around the left ear.

Locations

Country Name City State
China Beijing Tongren Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean change from Baseline in the FD Symptoms Index at 16 Weeks FD Symptoms Index to measure the subjective symptoms of dyspepsia. Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12
Primary Mean change from Baseline in the FDQOL at 16 Weeks FDQOL to measure the subjective quality of life. Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12
Secondary Mean change from Baseline in the HAMA at 16 Weeks HAMA to measure the subjective anxiety symptoms Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12
Secondary Mean change from Baseline in the HAMD at 16 Weeks HAMD to measure the subjective depression symptoms Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12
Secondary Mean change from Baseline in the SDS at 16 Weeks SDS to measure the subjective depression symptoms Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12
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