NCT07033013招募中不适用
A Randomized, Double Blind, Placebo Controlled, Clinical Study to Examine the Benefits of an Oral Product in Panelists With Menopausal Symptoms Including Vasomotor Symptoms (VMS).
Olly, PBC1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年7月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 24 hour effects following single dose of Mellow Menopause - Hot Flashes
研究概览
简要总结
Randomized, Double-Blind, Placebo-Controlled, Single-Center Clinical Study with a Run-in Baseline, Daily Diary Log, and Validated Questionnaires (Greene GCS) with Oral Dietary Supplement
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
- Triple (Participant, Care Provider, Investigator)
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 flashes 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
- •NORMAL BMI (per metropolitan life tables): under 30 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 panelist's health under risk, such as: thyroid disease, diabetes mellitus, history of hormone dependent (gynecological) cancer, endometrial hyperplasia, uterine cancer, endometrial cancer, drug and alcohol abuse, mental disorder, abnormality in renal and liver functions, personal or family history of breast cancer in a first degree relative, and history of clotting disorder such as deep vein thrombosis.)
- •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
- •Use of other menopause supplements or drugs
- •Uncontrolled hypertension (160/100 mmHg or higher, measured after 10 min of seated rest)
- •Oophorectomy or amenorrhea > two years.
- •Participating in a different clinical trial within one month of the start of this clinical trial or planning to participate in another clinical trial during the trial period
- •Continuous intake of foods based on Cynanchum wilfordii Hemsley, Phlomis umbrosa Turczaninow, and Angelica gigas Nakai within the past month
- •Employees of the institute or the brand owner or the manufacturers of the product
- •Note: Habitual medicine and supplement intake will be registered prior to inclusion in the study
研究组 & 干预措施
Placebo
Placebo Comparator
Instructions: Take 1 capsule when having a hot flash at the onset of a hot flash (not to exceed 1 capsule/day). Only treat 1 hot flash during a 24-hour period.
干预措施: Placebo (Dietary Supplement)
Dietary Supplement with actives
Active Comparator
Instructions: Take 1 capsule when having a hot flash at the onset of a hot flash (not to exceed 1 capsule/day). Only treat 1 hot flash during a 24-hour period.
干预措施: Dietary Supplement with actives (Dietary Supplement)
结局指标
主要结局
24 hour effects following single dose of Mellow Menopause - Hot Flashes
时间窗: From baseline Day 7 to Treatement Day 1 (Day 8 of study)
To assess the efficacy for improvement of a treatment product on menopausal vasomotor symptoms (hot flashes- intensity, duration) within 24 hours compared to placebo through daily diary data and MenoLife application based diary.
次要结局
- Improvement of overall daily menopausal vasomotor symptoms(from enrollment to end of study at Day 15)
研究者
研究点 (1)
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