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临床试验/NCT02067572
NCT02067572已完成不适用

A Comparison of the Effectiveness of Normal Saline Mouthwash and Mouthwash Based on Tea Solution From Salvia Officinalis (SO) in Palliative Care. A Randomized Controlled Trial

Lovisenberg Diakonale Hospital2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2014年3月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
88
试验地点
2
主要终点
Oral health (OMAS)

研究概览

简要总结

This study examines the effectiveness of an herbal mouthwash made from salvia in maintaining good oral health among patients in palliative care. It is hypothesized that using the mouthwash made from salvia will result in better oral health and more oral comfort than using with conventional normal saline mouthwash.

详细描述

The aim of this study is to examine the effectiveness of an herbal mouthwash made from salvia officinalis (SO) in maintaining good oral health among patients in palliative care. The study compares a mouthwash based on salvia tea solution with conventional normal saline mouthwash and addresses the following research questions:

  1. Does the SO-based mouthwash provide a better treatment than conventional normal saline in maintaining good oral health in terminally ill patients?
  2. Is there a difference in the individual perception of oral comfort in patients receiving SO versus patients receiving saline rinsing solution?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, 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

入选标准

  • Attending bedded unit at Hospice
  • Over 18 years of age and able to provide written formal consent
  • Diagnosed with advanced cancer
  • Patient with positive response when asked if they experience oral discomfort or complications.

排除标准

  • Estimated life expectancy prognosis of less than 2 weeks
  • Significant cognitive impairment
  • Current use of antifungal medication
  • Currently receiving radiation therapy or chemotherapy
  • Epileptic

结局指标

主要结局

Oral health (OMAS)

时间窗: after 4 days of using mouthwash

Oral Mucositis Assessment Scale (OMAS)

Oral health (clinical evaluation)

时间窗: after 4 days of using mouthwash

Clinical evaluation by dentist

Patient's perception of oral comfort

时间窗: after 4 days of using mouthwash

Questions regarding oral discomfort and EORTC-OH17

次要结局

  • General symptom experience(after 4 days of using mouthwash)

研究者

发起方
Lovisenberg Diakonale Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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