Phase III Randomized Open-label Clinical Trial Comparing Cleanoze® Irrigation Device With Powder Preparation Versus Conventional Irrigation Method for Chronic Rhinitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Satisfaction score
研究概览
简要总结
The investigators proposed that the Cleanoze® is superior to the traditional nasal saline irrigation in term of the ease of use which will resulting in a better quality of life of the participants. This study will compared the efficacy, adverse reactions, complications and ease of use of Cleanoze® comparing with normal saline solution
详细描述
Cleanoze® consists of a powder made up of Sodium chloride and Sodium Bicarbonate. This powder when dissolved in 250 ml of water is closely resembles the content of a body fluid which normally baths the outside of the cells of the body. This fluid is isotonic solution.
The nasal saline irrigation is the common procedure for upper respiratory tract infection patients including chronic rhinitis. The physician usually order the normal saline with appropriate medication e.g. anti-histamines, nasal steroids and anti-biotics to treat this condition.
The investigators proposed that the Cleanoze® is superior to the traditional nasal saline irrigation in term of the ease of use which will resulting in a better quality of life of the participants. This study will compared the efficacy, adverse reactions, complications and ease of use of Cleanoze® comparing with normal saline solution.
Study Population: Any patients with chronic rhinitis (e.g. allergic rhinitis, vasomotor rhinitis) will be randomized to receive the study or control medication. The investigators will include the children 5 years and above which able to doing the lavage under the parents assistant or by them self.
Study Design: Phase III randomized controlled trial
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
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patients with chronic rhinitis conditions regardless of any cause (e.g. allergic, irritant, infection)
排除标准
- •Acute or chronic rhinosinusitis
- •Acute nasopharyngitis (common cold)
- •Patients with a tendency to aspirate such as cerebrovascular accident, cranio-facial diseases.
- •Sinunasal, nasopharyngeal and skull base tumors
- •Age under 5 years old.
- •Cannot administer a saline irrigation under the assistant of a care giver.
研究组 & 干预措施
Cleanoze®
Cleanoze® consists of a powder made up of Sodium chloride and Sodium Bicarbonate. This powder when dissolved in 250 ml of water is closely resembles the content of a body fluid which normally baths the outside of the cells of the body. This fluid is isotonic solution.
The patient will be instructed to use this isotonic solution for nasal irrigation daily.
干预措施: Cleanoze® (Drug)
Syringe irrigation
Nasal irrigation using sterile 0.9% NaCl 250 ml by 20 ml syringe
The patient will be instructed to use this isotonic solution for nasal irrigation daily.
干预措施: Saline (Syringe irrigation) (Drug)
结局指标
主要结局
Satisfaction score
时间窗: 1 month
This score will be evaluated at the end of 1 month using using the satisfaction questionaire
次要结局
- The symptoms score of the patients(1 month)
- The durability of the Cleanoze® device(1 month)
- The Sino-Nasal Outcome Test-22 Questionnaire (SNOT-22) score(1 month)
- The adherence to Cleanoze® devic(1 month)
- Adverse events(1 month)
研究者
Patorn Piromchai
Assistance Professor
Khon Kaen University