NCT00723268Unknown2 期
Evaluation of Therapeutic Effect of 0.5 mg Colchicine and 5 mg Prednisolone on Oral Aphthae
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- frequency of ulcers
研究概览
简要总结
The purpose of this study is to determine whether low doses of prednisolone, or colchicine are effective in the treatment of oral aphthae.
详细描述
Treatment of recurrent aphthous stomatitis (RAS) remains, to date, empirical and non-specific. The main goals of therapy are to minimize pain and functional disabilities as well as decrease inflammatory reactions and frequency of recurrences.
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
- Single (Investigator)
入排标准
- 年龄范围
- 15 Years 至 60 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
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
Prednisolone
Active Comparator
干预措施: Prednisolone (Drug)
Colchicine
Active Comparator
干预措施: Colchicine (Drug)
结局指标
主要结局
frequency of ulcers
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
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