The Effect of Topical Chamomile in the Prevention of Chemotherapy-induced Oral Mucositis (a Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Changes in severity of oral mucositis at different time points along the study
研究概览
简要总结
the main aim of this study is to clinically assess the effectiveness of topical chamomile oral gel in the prevention of chemotherapy-induced oral mucositis.
详细描述
The study was designed as a randomized, controlled, clinical trial. patients who were undergoing to receive chemotherapy were divided into three groups: Group I: was given conventional treatment. Group II: was given topical oral gel of chamomile. Group III: was given topical oral gel of chamomile in combination with the conventional treatment.
All patients have clinically evaluated at the start of the chemotherapy and three weeks later for pain and oral mucositis severity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are going to receive 5-Fluoroucil (5-FU) based chemotherapy regime.
- •Males and females with an age of not less than 20 years and not exceeding 70 years.
排除标准
- •Patients suffering from any uncontrolled systemic diseases that affect integrity of the epithelium (such as diabetes, cardiovascular, liver disorder and renal dysfunction)
- •Pregnant and lactating women
- •Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure
研究组 & 干预措施
Chamomile topical gel
Topical oral chamomile gel three times daily for three weeks.
Topical oral chamomile gel is prepared with the aid of Pharmacognosy and pharmaceutics departments, faculty of pharmacy, Alexandria University and mucoadhesive hydrogels (Carbopol® 970).
干预措施: chamomile topical oral gel (Drug)
conventional therapy
Conventional therapy (symptomatic treatment) which included:
Miconaz oral gel BBC oral spray Oracure gel
Dose: Three times a day for three weeks
干预措施: Miconazole Topical Gel (Drug)
conventional therapy
Conventional therapy (symptomatic treatment) which included:
Miconaz oral gel BBC oral spray Oracure gel
Dose: Three times a day for three weeks
干预措施: BBC oral spray (Drug)
conventional therapy
Conventional therapy (symptomatic treatment) which included:
Miconaz oral gel BBC oral spray Oracure gel
Dose: Three times a day for three weeks
干预措施: Oracure gel (Drug)
combination therapy
Topical oral chamomile gel three times daily for three weeks in combination with the symptomatic treatment
Symptomatic treatment which included:
Miconaz oral gel BBC oral spray Oracure gel
Symptomatic treatment dose: Three times a day for three weeks
干预措施: chamomile topical oral gel (Drug)
combination therapy
Topical oral chamomile gel three times daily for three weeks in combination with the symptomatic treatment
Symptomatic treatment which included:
Miconaz oral gel BBC oral spray Oracure gel
Symptomatic treatment dose: Three times a day for three weeks
干预措施: Miconazole Topical Gel (Drug)
combination therapy
Topical oral chamomile gel three times daily for three weeks in combination with the symptomatic treatment
Symptomatic treatment which included:
Miconaz oral gel BBC oral spray Oracure gel
Symptomatic treatment dose: Three times a day for three weeks
干预措施: BBC oral spray (Drug)
combination therapy
Topical oral chamomile gel three times daily for three weeks in combination with the symptomatic treatment
Symptomatic treatment which included:
Miconaz oral gel BBC oral spray Oracure gel
Symptomatic treatment dose: Three times a day for three weeks
干预措施: Oracure gel (Drug)
结局指标
主要结局
Changes in severity of oral mucositis at different time points along the study
时间窗: Up to 3 weeks
Oral mucositis will be evaluated by the World Health Organization (WHO) scale which record the extent and severity of oral mucositis at the third week after the first chemotherapy session.
次要结局
- Pain and discomfort severity at different time points along the study: Numeric Rating Scale(Up to 3 weeks)
研究者
Hams Hamed Abdelrahman
Assistant lecturer
Alexandria University