Phase 1 Evaluation of Therapeutic Effect of Chamomilla Tincture Mouthwash on Oral Aphthae
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- protocol designed to evaluate the effect of fluid extract from Chamomilla recutita's on treatment of aphthous stomatitis
研究概览
简要总结
Recurrent aphthous stomatitis is a difficult to treat and quite common chronic inflammatory disease of the oral mucosa. This study evaluates the fluid extract from Chamomilla recutita's safety and effectiveness in treatment of aphthous stomatitis .
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
- 12 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmation of clinical diagnosis of aphthae
- •Having the experience of oral aphthae at least once in a month
- •Two weeks wash out periods after the last treatment
排除标准
- •History of any systemic disease
- •Using drugs which affect immune system
- •Pregnancy and breast feeding
- •Aphthous related syndromes
研究组 & 干预措施
chamomilla tincture mouthwash
Chamomile comprises bisaboloids, matricine and chamazulene, flavonoids, and cumarins having therapeutical anti-inflammatory, analgesic, musculotropic, and spasmolytic action
干预措施: chamomilla tincture mouthwash (Drug)
placebo mouth wash
placebo mouthwash is produced with the same taste and smell for using in placebo/ control group.
干预措施: placebo mouthwash (Drug)
结局指标
主要结局
protocol designed to evaluate the effect of fluid extract from Chamomilla recutita's on treatment of aphthous stomatitis
时间窗: 3 months
This study evaluates the fluid extract from Chamomilla recutita's effectiveness on healing rate of aphthous stomatitis, and reducing ulcer size
次要结局
- This study aimed to evaluate the efficacy of chamomile mouthwash of decreasing the pain and frequency of oral aphthous ulcer(3 months)