NCT05617287已完成不适用
An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Perimenopause and Menopause
Semaine Health2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2022年9月3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
- 42
- 试验地点
- 2
- 主要终点
- Changes in perceived discomfort associated with the most common symptoms linked with perimenopause and menopause
研究概览
简要总结
A combination of synergistic dietary supplements is hypothesized to significantly improve self-reported measures of menopausal symptoms when compared with a baseline without the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 57 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Ability to take oral medication and be willing to adhere to the dietary supplement regimen (1 capsule per day)
- •Moderate self-reported discomfort related to perimenopause or menopause. Participants will complete the menopause well-being survey and must answer an average of "moderate" or higher.
排除标准
- •Current use of medication for high blood pressure or for blood thinning
- •Currently undergoing chemotherapy or has previously been treated for cancer
- •Pregnancy, breastfeeding, or attempting to become pregnant during the study
- •Known allergic reactions to components of the dietary supplement (red clover extract, olive extract, bergamot extract )
结局指标
主要结局
Changes in perceived discomfort associated with the most common symptoms linked with perimenopause and menopause
时间窗: 12 weeks
Symptoms will be reported by the participant on a scale of perceived discomfort and will include rankings for mood, anxiety, fatigue, sleep quality, hot flashes, and libido. This survey will be based on the widely used and validated Menopause Rating Scale (MRS). The MRS will be modified to increase dynamic range by changing the response gradations from 5 to 7.
次要结局
未报告次要终点
研究者
研究点 (2)
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