A Comparison of Farabloc Fabric With Placebo on Alleviation Hot Flash in Menopausal Women
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Frequency of hot flashes
研究概览
简要总结
This is a prospective, randomized, double-blind, crossover study. The purpose of this study is to determine whether Farabloc fabric is effective in alleviation of hot flash symptoms in menopausal women. This study will require all prospective participants to fill out a week of Hot Flash Diary to determine eligibility before beginning the study. All prospective participants will be assessed for hot flash frequency, hot flash distress and hot flash severity according to their perception in the Hot Flash Diary during the experimental period.
详细描述
Fifty menopausal volunteers will be randomly assigned to two groups, one receiving Farabloc fabric containing Farabloc (experimental), and the other a similar-appearing fabric made of Nylon (placebo).
All eligible participants will be selected by the initial interview. The following information will be collected during interview process.
- Address
- Medical history
- Concomitant medication
- Allergies
Participants will be asked the following:
- On a scale from 1 to 10, how much are you bothered by your hot flashes?
- Do these hot flashes wake you up at night? Around how many times do they occur at night?
- What are you expectations about this study?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with 12 months amenorrhea
- •Experiencing more than 2 nocturnal hot flashes nightly.
排除标准
- •Other medical conditions associated with night sweats
- •Currently on medication associated with night sweats
- •Less than 2 nocturnal hot flashes per night
- •Allergies to metals
- •Abnormal mental status
- •MRS scale rating of mild or above
- •Currently on hormone replacement therapy or herbal supplements and cannot safety discontinue these for the duration of the study.
结局指标
主要结局
Frequency of hot flashes
时间窗: in the past 24 hours
The number of hot flashes subjects experienced in the past 24 hours
次要结局
- Severity of hot flash(In the past 24 hours)