Phase 2 Study of Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Serial questionnaires within 1 week post treatment to assess patient's perception, patient's pain relief and local adverse events in comparison to his past experience with other local treatments for oral ulcers.
研究概览
简要总结
Recurrent Aphthous Stomatitis (RAS) of the oral mucosa is a common and painful condition. Despite advances in therapeutic means there is still necessary to find a way to alleviate the local pain and discomfort induced by the mucosal ulceration.
The hypothesis was to study the effectiveness and acceptance of a herbal adhesive tablets in the treatment of RAS.
Participants in the study will be examined for oral lesions, will be instructed how to apply the oral-tablet, and will be interviewed during the follow-up period up to one week after the application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- •Oral lesion suspected to be malignant.
- •Ulcerative oral lesion other than RAS.
- •Another experimental oral intervention within the last 24 hours.
- •Pregnant women.
- •Allergy to components of the Pro-pe adhesive tablet
结局指标
主要结局
Serial questionnaires within 1 week post treatment to assess patient's perception, patient's pain relief and local adverse events in comparison to his past experience with other local treatments for oral ulcers.
次要结局
未报告次要终点