NCT05872464尚未招募不适用
Efficacy and Safety of Artificial Saliva Containing Cumin and Ginger Extract in Head and Neck Cancer Patients With Xerostomia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 52
- 主要终点
- Amount of saliva
研究概览
简要总结
The objectives of this study are to evaluate efficacy and safety of artificial saliva containing cumin and ginger extract in head and neck cancer patients with xerostomia.
详细描述
There are 52 patients in this study. They are divided into 2 groups which are artificial saliva containing cumin and ginger extract group (test group) 26 patients and placebo group 26 patients. The patients spray the sample into the mouth 3 times/day for 14 day. Amount of saliva, pH of saliva, xerostomia questionnaires, WHO Oral Mucositis Grading Scale, quality of life, adverse events, and satisfaction were assessed.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age more than 18 years
- •Head and neck cancer with xerostomia
- •6 months post radiation
- •Willing to participate in this study
排除标准
- •Sialolith or Sjogren's syndrome
- •Uncontrolled cancer
- •Using artificial saliva more than 2 weeks
- •Taking Pilocarpine or cevimeline more than 2 weeks
- •Allergic to cumin, ginger, xylitol, and glycerin
- •History of other oral mucosal diseases
- •Pregnancy and lactation
结局指标
主要结局
Amount of saliva
时间窗: 14 days
Spit saliva to the bottle for 5 min
次要结局
- Xerostomia questionnaires(14 days)
- Adverse reaction: Gastrointestinal trat reaction(14 days)
- Quality of life of the patient(14 days)
- Satisfaction of the patient(14 days)
- Acid and base characteristic of saliva(14 days)
- Oral Mucositis Grading Scale(14 days)
- Adverse reaction: Respiratory reaction(14 days)
- Adverse reaction: Skin reaction(14 days)
研究者
Pornanong Aramwit, Pharm.D., Ph.D
Professor
Chulalongkorn University
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