Chamomilla Recutita Use of Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Oral mucositis intensity
研究概览
简要总结
To determine the Chamomilla recutita solution dose needed to reduce the intensity and evolution time of oral mucositis in adult subjects submitted to HSCT.
详细描述
Population: adult subjects, submitted to hematopoietic stem cell transplantation (HSCT) at a cancer hospital in the interior of São Paulo State. The following inclusion criteria were adopted for sample selection purposes: subjects over 18 years of age, candidates for allogeneic HSCT and with intact oral cavity on the first day of conditioning. Subjects will be excluded if they present any adverse reaction to the active principles of Chamomilla recutita; receive oral or intravenous anticoagulation therapy; use oral or systemic topical anti-inflammatory medication; receive any other type of intervention for mucositis not included in the standard oral care protocol.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects over 18 years of age;
- •candidates for allogeneic HSCT;
- •with intact oral cavity on the first day of conditioning.
排除标准
- •present any adverse reaction to the active principles of Chamomilla recutita;
- •receive oral or intravenous anticoagulation therapy;
- •use oral or systemic topical anti-inflammatory medication;
- •receive any other type of intervention for mucositis not included in the standard oral care protocol.
结局指标
主要结局
Oral mucositis intensity
时间窗: The measurement will be held on the first day of the conditioning regimen to bone marrow grafting. In an expected average of 4 weeks
次要结局
未报告次要终点
研究者
Fernanda Titareli Merizio Martins Braga
PhD
University of Sao Paulo