Efficacy of Natural Enzymes Mouthwash: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Changes in symptoms
研究概览
简要总结
The goal of this clinical is to assess the efficacy of natural enzymes mouthwash in the treatment of xerostomia (dry mouth). The main questions it aims to answer are: (1) the efficacy of natural enzymes mouthwash in the symptomatic treatment of xerostomia; and (2) the response of xerostomia patients towards natural enzymes mouthwash. Participants were given a mouthwash to be used. Intervention group received natural enzymes moisturising mouthwash, while control group received benzydamine mouthwash. Mouthwashes were repacked, labelled with specific code and were given to participants by third-party. Subjects were instructed to rinse with the mouthwash 4 times per day at a specific period, for 2 weeks. Data were compared within each arm before and after using the mouthwashes; and between both arms after using the mouthwashes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years old and above,
- •complained of dry mouth (xerostomia), and
- •taking nutrition orally
排除标准
- •patients who had been using mouthwash for xerostomia in the past 1 week,
- •unable to provide saliva samples,
- •unable to chew paraffin wax for stimulated saliva,
- •patients with oral motor function deficits, and
- •those with severe cognitive deterioration.
结局指标
主要结局
Changes in symptoms
时间窗: At Day 0 and Day 14 of intervention
Symptoms of xerostomia assessment using Xerostomia Inventory
次要结局
- Salivary flow rate(At Day 0 and Day 14 of intervention)
- Changes in clinical signs(At Day 0 and Day 14 of intervention)