NCT06787443已完成不适用
A Randomized, Placebo Controlled Clinical Study to Examine the Clinical Benefits of an Oral Product in Subjects With Menopausal Symptoms Including Vasomotor Symptoms
Olly, PBC2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2024年5月10日最近更新:
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
- Changes of symptom scores in Daily Dairy
研究概览
简要总结
The objective of this study is to assess the safety and effectiveness of a dietary supplement for symptom relief in subjects with menopausal symptoms over the course of five weeks of continuous daily use.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy Females aged 40 to 65 years,
- •Self-reporting menopausal symptoms (> 5 hot flushes per day) and have been present for a minimum of previous 60 days prior to baseline visit.
- •Reporting a variable cycle length of > 7 days different from normal
- •BMI 20-40 kg/m2
- •Able to read, understand, and complete the study questionnaire and records.
- •Able to understand the study procedures.
- •Able to comply with all study requirements.
- •Written informed consent to participate in the study.
- •Willingness to actively participate in the study and to come to the scheduled visits.
排除标准
- •Pregnancy or breastfeeding.
- •Immune insufficiency
- •Women of childbearing potential including those still having a menstrual cycle on a regular basis who are not perimenopausal, menopausal or post-menopausal.
- •History of hysterectomy
- •Women on hormone replacement therapy
- •Use of systemic corticosteroids or immunosuppressant drugs.
- •Other diseases or medications that might directly interfere in the study or put the subject's health under risk.
- •Employees of the institute
- •Cardiovascular-, chronic liver-, thyroid or kidney diseases; a history of cancer; a disease or condition that could influence the participants' ability to follow the study protocol,
- •Alcohol or drug abuse,
- •Use of hormonal contraceptives within the last 3 months
- •BP ≥160/110 mmHg
- •Oophorectomy or amenorrhea > two years
结局指标
主要结局
Changes of symptom scores in Daily Dairy
时间窗: from enrollment to the end of study at five weeks
To assess changes in symptom scores attained from product use in subjects with menopausal symptoms, including acute effects
Changes of symptom scores in Mobile Application
时间窗: from enrollment to the end of study at five weeks
To assess changes in symptom scores attained from product use in subjects with menopausal symptoms, including acute effects
次要结局
- Changes in Menopause-Specific Quality of Life (MENQOL) Scores(from enrollment to the end of study at five weeks)
- Changes in Green Climacteric Scale (GCS) Scores(from enrollment to the end of study at five weeks)
- Changes in Perceived Stress Scale (PSS) Scores(from enrollment to the end of study at five weeks)
- Changes in Profile of Mood States (POMS) Scores(from enrollment to the end of study at five weeks)
- Changes in Pittsburgh Sleep Quality Index (PSQI) Scores(from enrollment to the end of study at five weeks)
研究者
研究点 (2)
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