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临床试验/NCT01431729
NCT01431729已完成不适用

Honey and a Mixture of Honey, Beeswax and Olive Oil-propolis Extract in Treatment of Chemotherapy-induced Oral Mucositis: a Randomized Controlled Pilot Study

mamdouh abdulmaksoud abdulrhman1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2010年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
"Recovery time" , defined as the number of days from initiation of treatment to when complete healing of all ulcers will occur.

研究概览

简要总结

Although, oral mucositis has been studied for many years, no available treatment has been shown to be effective in preventing or treating mucositis. Based on the observations that honey and other products of honeybees have anti-inflammatory, anti-oxidant, anti-microbial and wound healing effects, the present study aims at evaluation of the effect of topical application of honey and a mixture of honey, beeswax and olive oil-propolis extract, as natural products, in treatment of chemotherapy-induced oral mucositis in children with acute lymphoblastic leukemia (ALL). This is a randomised controlled clinical trial in which eligible patients were randomly assigned into three equal treatment groups. Group 1 received 15 gm honey applied topically to the affected oral mucosa three times daily. Group 2 received 5 gm of a mixture of honey, olive oil-propolis extract and bees wax (HOPE) applied topically to the oral mucosa three times daily. Group 3 served as control and received a 7.5% benzocaine gel applied to the areas of ulcers three times daily.

详细描述

All patients with ALL during the consolidation phase of treatment, and with chemotherapy-related oral mucositis grades 2 and 3 were candidates for this trial.Exclusion criteria included the presence of any of the following: (1) coexisting diabetes mellitus, (2) administration of antiviral, antifungal therapy and / or any other treatment for oral mucositis before enrollment in the study, (3) presence of neutropenia (absolute neutrophilic count [ANC] ≤ 1500/mm3), (4) presence of advanced or severe periodontitis (patients with periodontal pockets of 6 mm or more. The primary outcome measure was the "recovery time", defined as the number of days from initiation of treatment to when complete healing of all ulcers occurred.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All patients with ALL during the consolidation phase of treatment, and
  • with chemotherapy-related oral mucositis grades 2 and 3

排除标准

  • coexisting diabetes mellitus,
  • administration of antiviral, antifungal therapy and / or any other treatment for oral mucositis before enrollment in the study,
  • presence of neutropenia (absolute neutrophilic count [ANC] ≤ 1500/mm3),
  • presence of advanced or severe periodontitis (patients with periodontal pockets of 6 mm or more)

结局指标

主要结局

"Recovery time" , defined as the number of days from initiation of treatment to when complete healing of all ulcers will occur.

时间窗: 10 days

次要结局

未报告次要终点

研究者

发起方
mamdouh abdulmaksoud abdulrhman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

mamdouh abdulmaksoud abdulrhman

professor of pediatrics, faculty of medicine, ain shams university

Ain Shams University

研究点 (1)

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