Xerostomy Treatment in Patients With Sjogren's Syndrome in Chile :A Double Blind Control Trial Comparing Orally Pilocarpine Drops and Artificial Saliva
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- To assess and compare the safetyness and efficacy of pilocarpine drops versus artificial saliva as symptomatic treatment for dry mouth and dry eyes caused by SS in a multicenter, doubleblind, controlled trial.
研究概览
简要总结
The purpose of this study is to assess and compare the safetyness and efficacy of pilocarpine drops versus artificial saliva as symptomatic treatment for dry mouth and dry eyes caused by SS in a multicenter, doubleblind, controlled trial.
详细描述
Title:
Xerostomy treatment in patients with Sjogren's syndrome in Chile :A double blind control trial comparing orally Pilocarpine drops and Artificial Saliva
Authors:
Cristian Vera Kellet, Mirtha Cifuentes Mutinelli. Affiliations: Pontificia Universidad Catolica de Chile
BACKGROUND Sjogren's syndrome (SS) is characterized by diminished exocrine secretions with the resultant xerostomia and xerophthalmia due to slowly progressive infiltration of lacrimal and salivary glands by inflamatory cells.
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
- Double (Participant, 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
- 否
入选标准
- •Patiens over 18 years, with primary or secondary Sjogren's Syndrome and xerostomia.
排除标准
- •Patiens with cardiac, pulmonary, renal, gastric diseases,
- •Patients with diabetes, glaucoma, Multipleesclerosis,
- •Pregnant women.
研究组 & 干预措施
a,b
Compare Pilocarpine and Artificial saliva
干预措施: pilocarpine (Procedure)
a,b
Compare Pilocarpine and Artificial saliva
干预措施: Artificial Saliva (Drug)
结局指标
主要结局
To assess and compare the safetyness and efficacy of pilocarpine drops versus artificial saliva as symptomatic treatment for dry mouth and dry eyes caused by SS in a multicenter, doubleblind, controlled trial.
时间窗: 12 weeks
次要结局
- Determine on a subjetive manner wich treatment is better fot patients.(12 weeks)