Efficacy of Buffered Hypertonic Saline Nasal Irrigation in Children With Symptomatic Allergic Rhinitis : A Randomized Double-blind Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- The change from baseline in SCT at 10 minute after nasal irrigation of BHS and NSS
研究概览
简要总结
The purpose of this study is to investigate whether buffered hypertonic saline (BHS) is superior to normal saline (NSS) for improving mucociliary function and relief nasal symptoms in children with allergic rhinitis.
详细描述
- BHS is superior to NSS for improving mucociliary function that by measure saccharine clearance time(SCT)at 10 minute after nasal irrigation compare to baseline.
- BHS is superior to NSS for clinical effectiveness at short period and 1 month follow up
- at short period: compare the following results at baseline and 10 minute after nasal irrigation
- total nasal symptom score(TNSS)
- satisfaction to nasal irrigation
- side effect
- at 2 and 4 weeks follow up : compare the following results at baseline and 10 minute after nasal irrigation
- quality of life(by specific questionnaire for Thai allergic rhinoconjunctivitis patient)
- medication use to relieve AR symptom(from diary record)
- compliance for nasal irrigation (from diary record)
- side effect (from diary record)
- overall satisfaction to nasal irrigation
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 6-15 years
- •diagnosed AR obtained by history, physical examination and positive skin prick test or nasal cytology
- •TNSS ≥ 4 at the first visit of this study
排除标准
- •Patients with a history of nasal anatomical defects
- •Abnormal nasal ciliary function or an upper respiratory tract infection in the preceding 2 weeks
研究组 & 干预措施
NSS irrigation salt
干预措施: NSS nasal irrigation salt (Drug)
BHS nasal irrigaiton salt
干预措施: BHS nasal irrigation salt (Drug)
结局指标
主要结局
The change from baseline in SCT at 10 minute after nasal irrigation of BHS and NSS
时间窗: baseline, 10 minute after nasal irrigaiton
SCT method : subjects seated with their head upright. A rhinoprobe was used to place a small piece of saccharine on the medial aspect of the inferior turbinate approximately 1 cm, posterior to the nasal vestibule. The SCT was recorded as the subject's first perception of a sweet taste.
次要结局
- The effect of BHS and NSS on clinical effectiveness(1st visit, 2nd week and 4 week follow up)
研究者
araya satdhabudha
clinical professor
Thammasat University