Transcutaneous Auricular Vagus Nerve Stimulation in the Treatment of Functional Dyspepsia : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Mean change from Baseline in the FD Symptoms Index at 16 Weeks
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Age >=18 and Age <=
- •Clinical diagnosis of functional dyspepsia.
排除标准
- •1. History of depression, tumors, thyroid disease, diabetes, cardiac diseases.
- •History of gastrointestinal surgery.
- •Pregnant or lactating women.
结局指标
主要结局
Mean change from Baseline in the FD Symptoms Index at 16 Weeks
时间窗: Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12
FD Symptoms Index to measure the subjective symptoms of dyspepsia.
Mean change from Baseline in the FDQOL at 16 Weeks
时间窗: Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12
FDQOL to measure the subjective quality of life.
次要结局
- Mean change from Baseline in the SDS at 16 Weeks(Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12)
- Mean change from Baseline in the HAMD at 16 Weeks(Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12)
- Mean change from Baseline in the HAMA at 16 Weeks(Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12)