临床试验/NCT05413096

NCT05413096已完成早期 1 期

Combination of Diclofenac Potassium and Propolis in the Therapy of Oral Aphthosis

Al-Azhar University2 个研究点分布在 1 个国家目标入组 100 人开始时间: 2021年6月1日最近更新: 2023年7月21日

适应症

试验速览

阶段: 早期 1 期
状态: 已完成
发起方: Al-Azhar University
入组人数: 100
试验地点: 2
主要终点: chronic oral mucosal disease questionnaire

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

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

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

发起方

Al-Azhar University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Mohamed Ismail Assadawy

principle investigator

Al-Azhar University

研究点 (2)

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