NCT01974414已完成1 期
Cedar Honey in Treatment of Oral Lichen Planus: a Randomized Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- severity of lesions
研究概览
简要总结
The study aimed to evaluate the effect of cedar honey in treatment of erosive and atrophic oral lichen planus ( a common oral problem).
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically and histopathologically confirmed oral lichen planus without dysplasia in histopathologic evaluation
- •Severity of pain≥2 (VAS score)
- •Severity of lesions≥2 (tong prasom criteria)
- •absence of any treatment in the last month
- •absence of kidney or liver diseases( due to systemic administration of fluconazole to both groups)
排除标准
- •evidence of lichenoid reaction in clinical or histopathologic assessment
- •loss of follow up
- •pregnant patients
- •diabetic patients
- •any other mucosal disease
- •any severe systemic disease
- •patients who refuse doctor's advice
- •any unexpected adverse effect of honey
研究组 & 干预措施
cedar honey
Active Comparator
The two study groups were provided with standard treatment(dexamethasone and Fluconazole).The Case group(A) received cedar honey, 20 ml 3 times daily by swish and swallow technique, in addition to the standard treatment .
干预措施: orally administered cedar honey (Drug)
结局指标
主要结局
severity of lesions
时间窗: 4 weeks
severity of lesions due to thong prasom criteria
次要结局
- size of lesions(4 weeks)
研究者
Pegah Mosannen Mozafari
Assistant professor of Oral medicine
Mashhad University of Medical Sciences
研究点 (1)
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