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临床试验/NCT05765526
NCT05765526已完成不适用

A Novel Electrolyzed Water Spray Reduces Discomfort or Itching Scores of Patients With Scalp Discomfort or Itching: A Clinical Study

Dove Medical Press Ltd1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年1月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
A discomfort or itching scale made by modifing a pain scale (NPRS)

研究概览

简要总结

The purpose of this study is to test whether the reduction of the discomfort or itching with the scalp of patients by use of the novel electrolyzed water spray will produce improvement in the condition of the scalp.

详细描述

In this study, water inculding tap water,pure water and salt water, and an apparatus for producing electrolyzed water (https://www.deposon.com.cn; https://www.deposon.com)were used to generate an electrolyzed water mist spray or spray. This instantly generated electrolyzed water mist spray or spray has oxidation-reduction potential (ORP) ≥1200mv,and contains non-specific total oxidation capacity which equals to 0.28±0.10ppm,0.06±0.04ppm and 3.92±0.39ppm of desolved ozone. This instantly generated electrolyzed water mist spray or spray does not release detectable ≥0.1mg/m3 of gaseous ozone. This instantly generated electrolyzed water mist spray or spray has pH 8.4±0.4 and releases negative air ion.The apparatus for producing electrolyzed water has a positive electrode which is covered by a conductive diamond material (Patent# CN215308550U). This is an open-label, single-arm and before and after treatment comparison study. In this study, this novel electrolyzed water device and the water spray are used to treat scalp itching. The reduction in the scalp of discomfort or itching evaluation and adverse event assessments will be performed at each visit. Safety analysis will be assessed based on the reports of adverse events during the study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • The patients with scalp discomfort or itching

排除标准

  • severe scalp discomfort or itching; 80 years or elder

结局指标

主要结局

A discomfort or itching scale made by modifing a pain scale (NPRS)

时间窗: 5 days

This Score is based on descriptions of the discomfort or itching that patients rate 0-10 to assess the condition of their scalp. A higher score means a worse outcome. 0 means "no discomfort or itching " and 10 means "the most discomfort or itching".

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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