A pilot interventional study evaluating transauricular vagus nerve stimulation (TaVNS) as adjunctive therapy in chronic spontaneous urticaria (CSU)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
This is a pilot study evaluating Transauricular Vagus Nerve Stimulation (TaVNS) as an adjunctive therapy to antihistamines for chronic spontaneous urticaria (CSU) in 40 patients over 12 months. The study is prospective, interventional, and controlled, assessing efficacy via UAS7 scores, quality-of-life measures, lab markers, and safety, with plans for statistical analysis and ethical compliance.
This 12-month pilot study with total 40 patients ( 30 intervention, 10 control) assesses TaVNS (left ear cymba concha, 25 hertz, 30 min for 8 sessions over 4 weeks) alongwith tablet levocetirizine as required versus levocetirizine alone in adults with CSU (more than 6 weeks duration, poor antihistamine response). Primary outcome of UAS7 reduction of 7 or more points at week 8. Secondary outcomes of changes in QoL (DLQI, UCT, CuQOL), tablet count, laboratory parameters, relapse rate and safety events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults with diagnosis of chronic spontaneous urticaria of duration six weeks or more.
- •Inadequate control on intermittent or standard dose antihistamines.
- •Willing and able to provide written informed consent.
排除标准
- •Physical urticarias, urticarial vasculitis, or predominant alternative dermatoses.
- •Cardiac pacemaker or defibrillator, seizure disorder, or implanted stimulators.
- •Pregnant or lactating women.
- •Severe comorbid systemic illnesses.
- •Local ear pathology preventing electrode placement.
研究者
Dr Priyansh Gupta
ESIC Medical college and hospital, nit 3, faridabad