Reflux Esophagitis Clinical Trial
Official title:
Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Reflux Esophagitis: a Pilot Study
Verified date | June 2024 |
Source | Beijing Tongren Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Objective: To evaluate the effect of Transcutaneous auricular vagus nerve stimulation for the patients reflux esophagitis. Methods: We accrued 29 patients at Beijing TongRen Hospital Affiliated to Capital Medicine University of. 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 and 24 weeks. Endoscopy, reflux diagnostic questionnaire (RDQ), gastrointestinal symptom rating scale (GSRS), and SF-36 were performed to evaluate the therapeutic effects. A difference of P < 0.05 was considered statistically significant.
Status | Completed |
Enrollment | 29 |
Est. completion date | November 1, 2020 |
Est. primary completion date | October 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 41 Years to 66 Years |
Eligibility | Inclusion Criteria: 1. Age >=18 and Age <=70. 2. Clinical diagnosis of reflux diagnostic. Exclusion Criteria: 1. History of cirrhosis, renal impairment, tumors, thyroid disease, diabetes, Crohn's disease, or ulcerative colitis. 2. History of GI or abdominal surgery. 3. Pregnant or lactating women. |
Country | Name | City | State |
---|---|---|---|
China | Wu Dong | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Tongren Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean change from Baseline in the reflux diagnostic questionnaire(RDQ) at 12 Weeks | The RDQ was used to assess the subjective reflux symptoms covering a 1-wk recall period. RDQ is categorized into four symptom clusters depicting heartburn, chest pain, acid reflux, and food reflux. The total RDQ scores (eight items) were calculated. Patients with RDQ = 12 points were considered to have a relapse. | Day 0 and postintervention at Week 12 | |
Secondary | Mean change from Baseline in the Gastrointestinal symptom scale(GSRS) rating scale at 12 Weeks | GSRS to measure the subjective gastrointestinal symptoms | Day 0 and postintervention at Week 12 | |
Secondary | Mean change from Baseline in the 36-items Short Form(SF-36) at 12 Weeks | SF-36 to measure quality of life | Day 0 and postintervention at Week 12 |
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