Efficacy of Standardized-propolis Extract (EPP-AF®) Gel Formulation as Buccal Antiseptic in Elderly People
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from Newton Score at 14 days
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of propolis on the treatment of oral candidiasis, more specifically denture stomatitis. Half of participants will receive a standardized-propolis (EPP-AF®) gel formulation while the other half will receive miconazole gel, both for oral use.
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
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elderly patients with denture stomatitis
排除标准
- •Recent use of anti fungals or antibiotics(2 months or less), dementia
研究组 & 干预措施
Propolis
Standardized-propolis extract (EPP-AF®) oral gel formulation, 3 times a day, for 14 days
干预措施: Propolis (Other)
Miconazole
Miconazole 20mg/g oral gel,3 times a day, for 14 days
干预措施: Miconazole (Drug)
结局指标
主要结局
Change from Newton Score at 14 days
时间窗: Day 14
Clinical assessment of buccal lesions localized at hard palate. The score utilized to measure the intensity of lesions will be Newton classification (I - punctate in the palate; II - extensive smooth reddened appearance; III -extensive reddening with hyperplastic growth) and the outcome will be the reduction of Newton's score comparing day 1 with day 14.
次要结局
- Assessment of gel acceptability(Day 7)
- Assessment of adverse events(Day 7 and 14)
- Anti fungal activity(Day 1 and 14)
研究者
Erica Negrini Lia
Pos doctoral
University of Sao Paulo