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临床试验/CTRI/2025/10/096186
CTRI/2025/10/096186尚未招募2 期

Effectiveness of coconut oil aloe vera mouth rinse on radiation-induced xerostomia among head and neck cancer patients.

Ms Chinthaja J1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2025年10月20日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
82
试验地点
1
主要终点
Reduction in severity of xerostomia measured using Challacombe Oral Dryness Scale and subjective symptoms using Groningen Radiation-Induced Xerostomia (GRIX) Questionnaire.

研究概览

简要总结

This study aims to evaluate the efficacy of coconut oil aloe vera mouthrinse on radiation-induced xerostomia among patients with head and neck cancer. A total of 82 patients will be recruited using purposive sampling and allocated into experimental and control groups. The experimental group will receive coconut oil aloe vera mouth rinse thrice daily for 7 days, while the control group will receive standard care. The severity of xerostomia will be assessed using the Challacombe Oral Dryness Scale and subjective symptoms using the GRIX Questionnaire. This study is significant as it will give evidence of the effectiveness of a natural, non-invasive treatment for radiation-induced xerostomia. The findings will help researchers better understand whether this strategy can help treat dry mouth symptoms in head and neck cancer patients without the use of medicines. Depending on the findings, the study may influence therapeutic practices and inform judgements on cost-effective xerostomia care options, with the ultimate goal of improving patient comfort before and after radiation therapy

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Cancer patients who:
  • Have received external radiation therapy targeting the head and neck areas, with a minimum of four sessions.
  • Experience mild xerostomia (scores one to three) to moderate xerostomia (scores four to six) after radiation therapy.

排除标准

  • Cancer patients who:
  • Have a history of xerostomia before receiving radiation therapy.
  • Are allergic to coconut oil or aloe vera.
  • Experience difficulty in performing mouth rinsing.
  • Have undergone oral surgery recently.
  • Have any systemic diseases that reduce or suppress salivation.
  • Are using medications known to suppress salivation.

结局指标

主要结局

Reduction in severity of xerostomia measured using Challacombe Oral Dryness Scale and subjective symptoms using Groningen Radiation-Induced Xerostomia (GRIX) Questionnaire.

时间窗: Baseline (Day 0), alternate days up to Day 7

次要结局

  • Safety of using coconut oil aloe vera mouth rinse

研究者

发起方
Ms Chinthaja J
申办方类型
Other [Self funded]
责任方
Principal Investigator
主要研究者

Ms Chinthaja J

Nitte Usha Institute of Nursing Sciences

研究点 (1)

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