Efficacy of Traditional Persian Medicine Preparation Versus Artificial Saliva for Radiation Induced Xerostomia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- changes in patients' quality of life
研究概览
简要总结
Head and neck cancers(HNC) is one of the most common cancers worldwide. Xerostomia is one of the most common side effect of radiation therapy among patients with HNC. Mouth dryness significantly impairs patients' quality of life (QOL).
HNC.Regarding to traditional use of A. digitata and M. sylvestris in addition to known their beneficial effects in recent studies, we decided to design a randomized, controlled clinical trial to try to evaluate efficacy of the these herbs in QOL of HNC patients with radiation induced xerostomia
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
- 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 with head and neck cancer who had grade 1 and 2 xerostomia (based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0) and finished radiotherapy at least two months before the study(22).
排除标准
- •history of connective tissue disorder (e.g., Sjogren) other medical causes of xerostomia (such as diabetes, bowel and renal diseases), using antidepressants drugs, recurrence of cancer, end stage cancer, pregnancy, lactation history of hypersensitivity or allergy to A. digitata and M. sylvestris
研究组 & 干预措施
control
In the control group, patients received Hypozalix (artificial saliva)spray three times per day for a period of four weeks.
干预措施: Hypozalix spray (artificial saliva) (Drug)
intervention
Patients in intervention group received sachets containing 4 grams of mixed powder of A. digitata and M. sylvestris (in a proportion of 1:1), three times per day for a period of four weeks
干预措施: mixed powder of A. digitata and M. sylvestris (Drug)
结局指标
主要结局
changes in patients' quality of life
时间窗: 4 weeks
changes in patients' quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire\|(EORTC QLQ-H\&N 35)
次要结局
未报告次要终点
研究者
seyed hamdollah mosavat
assisstant professor
Shiraz University of Medical Sciences