Therapeutic Effects of "Ibuprofen, Diphenhydramine and Aluminium MgS" on Recurrent Aphthous Stomatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation
研究概览
简要总结
The intention of the study is to study the effects of Ibuprofen, Diphenhydramine and Aluminium MgS in decreasing the signs of recurrent aphthous stomatitis (RAS)
详细描述
Recurrent aphthous stomatitis (RAS) is the most painful oral lesion with a considerable prevalence . The most common aphthous ulcer treatments include applying topical agents such as antibiotics, Non Steroidal Anti Inflammatory Drugs (NSAIDs) to immunosuppressants.
The mixture of Diphenhydramine and Aluminum MgS suspension has been prescribed as an analgesic mouthwash for a long time in order to decrease a great number of oral ulcers symptoms such as aphthous ulcers. Ibuprofen is a potent NSAID with fair anti-inflammatory potential prescribed in dental pains.
This double-blind randomized clinical trial was conducted to assess the effect of Ibuprofen, Diphenhydramine and Aluminium MgS mixture on symptoms of aphthous ulcers.40 patients will be participating in this study,20 will receive the mixture of Diphenhydramine and Aluminium MgS while the other group will receive Ibuprofen, Diphenhydramine and Aluminium MgS mixture.
All patients will be instructed to apply the drug on the site of the ulcer 30-60 minutes before meals, 3 times daily. The ulcers will be assessed when the drug is applied for 3 days and the level of pain and irritation will be estimated by VAS (Visual Analogue Scale, a scaled ruler which the zero point displays the zone of lack of pain and the 10th point was considered as the zone of maximum pain).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •possessing at least one painful aphthous ulcer in the last 3 days
- •older than 10 years of age
排除标准
- •systemic disease or specific syndrome (such as Behcet's)
- •pregnancy
- •breastfeeding
- •allergy to NSAIDs
- •history of asthma, peptic ulcers, hepatic and renal failures and hemorrhagic disorders
- •consumption of anti-inflammatory medications in the last 24 hours
研究组 & 干预措施
5cc Ibuprofen100mg,10 cc Diphenhydramine25mg,10 cc AlMgS550mg
干预措施: Ibuprofen, Diphenhydramine and Aluminium MgS (Drug)
100 cc Diphenhydramine, 25 mg and 100 cc AlMgS 550 mg
干预措施: Diphenhydramine and Aluminium MgS (Drug)
结局指标
主要结局
Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation
时间窗: four days after the start of the study
pain sensation was measured by VAS (Visual Analogue Scale, a scaled ruler which the zero point displays the zone of lack of pain and the 10th point was considered as the zone of maximum pain)) 4 days after the consumption of the solution
次要结局
- The Effect of Ibuprofen, Diphenhydramine, Aluminium MgS and Diphenhydramine and Aluminium MgS in Decreasing the Pain Level and Burning Sensation(4 days after the solution consumption)
研究者
Pantea Nazeman
Miss
Qazvin University Of Medical Sciences