Efficacy (Preliminary) and Safety of Artificial Salivary Containing Cumin and Ginger Extract in Healthy Volunteer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Salivary acid and base value
研究概览
简要总结
This study is a preliminary clinical study about safety of artificial salivary containing cumin and ginger extract in 21 healthy volunteers. After the preliminary clinical study, safety of artificial salivary containing cumin and ginger extract in 112 healthy volunteers. The volunteers will be divided into 2 groups which are artificial salivary containing cumin and ginger extract group and commercial artificial salivary.
详细描述
This study is a preliminary clinical study about safety of artificial salivary containing cumin and ginger extract in 21 healthy volunteers. The volunteers will be divided into 3 groups which are artificial salivary containing 0.3% cumin and 0.05%ginger extract group, artificial salivary containing 0.3%cumin and 0.1%ginger extract group, and artificial salivary containing 0.3%cumin and 0.15%ginger extract group. The volunteers will be evaluated salivary volume by Schirmer test, salivary acid and base value by strip test, dry mouth by questionnaire, and adverse effects before and after using the artificial salivary for 30 min. After the preliminary clinical study, safety of artificial salivary containing cumin and ginger extract in 112 healthy volunteers. The volunteers will be divided into 2 groups which are artificial salivary containing cumin and ginger extract group and commercial artificial salivary. The volunteers will be evaluated salivary acid and base value by strip test and adverse effects by World Health Organization Oral Mucositis Grading Scale and questionnaire before and after using the artificial salivary (3 times/day) for 3 and 6 days. Then, the volunteers will stop using the artificial salivary for 7-10 days. After that, the volunteers will be used the artificial salivary for 3 days. All evaluation will be tested.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Age more than 18 years
- •World Health Organization Oral Mucositis Grading Scale =0
- •No using artificial salivary or activated salivary medicine more than 2 weeks
- •No cumin, ginger, xylitol, glycerin allergy
- •Have a willingness to participate in the study
排除标准
- •Uncontrolled disease
- •Dry mouth
- •Salivary gland disease, inflammation, or sialolith
- •Pregnancy or lactation
- •During participated in other study
结局指标
主要结局
Salivary acid and base value
时间窗: 6 days
Salivary acid and base value (scale 0 (acid) to 14 (base)) using strip test
次要结局
- Adverse event(6 days)
- Mucositis(6 days)
- Dry mouth status(6 days)
研究者
Pornanong Aramwit, Pharm.D., Ph.D
Professor
Chulalongkorn University