Efficacy and Safety of Artificial Saliva Containing Cumin and Ginger Extract in Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 26
- 主要终点
- Xerostomia symptoms using Xerostomia Inventory Score
研究概览
简要总结
Hemodialysis patients with xerostomia are divided into 2 groups which are group A (start with artificial saliva containing cumin and ginger extract for 2 weeks, free periods 2 weeks, then placebo for 2 weeks) and group B (start with placebo for 2 weeks, free periods 2 weeks, then artificial saliva containing cumin and ginger extract for 2 weeks). Amount of saliva (g/min), xerostomia's questionnaire, Increase of saliva score, World Health Organization Oral Mucositis Grading Scale, acid and base of saliva, quality of life's questionnaire will measure before, after using the sample for 7 and 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Hemodialysis patients with xerostomia (saliva flow rate less than 0.2 g/min)
- •Hemodialysed history more than 3 months
- •Be willing to participate in the study
排除标准
- •Patients with sialolith or Sjogren's syndrome
- •Uncontrolled other diseases
- •Using artificial saliva for more than 2 weeks
- •Taking pilocarpine and cevimeline
- •Allergic to ginger, cumin, xylitol, and glycerin
- •Have mucositis
- •Pregnancy or lactation
研究组 & 干预措施
Artificial saliva containing cumin and ginger extract
The sample will be sprayed 2 puff/time, 3 times/day, for 14 days.
干预措施: Artificial saliva containing cumin and ginger extract (Drug)
Placebo
The sample will be sprayed 2 puff/time, 3 times/day, for 14 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Xerostomia symptoms using Xerostomia Inventory Score
时间窗: 14 days
Patients give the score of Xerostomia Inventory questionnaire. The Xerostomia Inventory Score is graded 11 to 55 (Low score means low frequency xerostomia and high score means high frequency of xerostomia)
次要结局
- Acid and base of saliva(14 days)
- Salivary flow rate(14 days)
- Amount of saliva score(14 days)
- Quality of life score using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck 35(14 days)
- World Health Organization Oral Mucositis(14 days)
研究者
Pornanong Aramwit, Pharm.D., Ph.D
Professor
Chulalongkorn University