Combination of Diclofenac Potassium and Propolis in the Therapy of Oral Aphthosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- chronic oral mucosal disease questionnaire
研究概览
简要总结
The combination of diclofenac and propolis could enhance the healing of recurrent aphthous ulcers, instantly relieve symptoms, improve the quality of life, and present a de novo and cost-effective regime help in oral ulcer treatment. This study aimed to evaluate the influence of diclofenac and propolis combination as a gel in the treatment of recurrent oral ulceration
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
caregiver and participants and investigator are masked
入排标准
- 年龄范围
- 5 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients have an oral mucosal ulcer
排除标准
- •patients allergic to any component of the diclofenac formulation and other NSAIDs
研究组 & 干预措施
placebo tube
neutral material without any biological effects
干预措施: placebo (Other)
Combination of diclofenac potassium and propolis
active agents combination of diclofenac potassium 3% (10 mg/g, 60 g, EMS) and Propolis 5% gel
干预措施: Combination of diclofenac potassium and propolis (Combination Product)
结局指标
主要结局
chronic oral mucosal disease questionnaire
时间窗: 10 days
patient response
次要结局
- ulcer characters(10 days)
研究者
Mohamed Ismail Assadawy
principle investigator
Al-Azhar University