Honey and a Mixture of Honey, Beeswax and Olive Oil-propolis Extract in Treatment of Chemotherapy-induced Oral Mucositis: a Randomized Controlled Pilot Study
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
- 否
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
mamdouh abdulmaksoud abdulrhman
professor of pediatrics, faculty of medicine, ain shams university
Ain Shams University
