A Clinical Trial to Examine the Efficacy of a Supplement to Support Hormone Regulation in Women
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Hormone Levels Blood Panel (estradiol, testosterone, DHEA, insulin, and progesterone)
研究概览
简要总结
This randomized, triple-blind, placebo-controlled trial will evaluate the efficacy of Live Conscious's Beyond Hormone supplement in regulating hormone production in women. The study involves 50 generally healthy female participants aged 25-45 who are not menopausal. The trial spans three menstrual cycles and assesses both objective hormone levels and subjective well-being through blood tests and questionnaires, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female at-birth, aged 25-
- •Not menopausal or perimenopausal.
- •Regularly menstruating.
- •Not taking any medication, supplement, or vitamin affecting hormone levels.
- •Generally healthy and not living with any uncontrolled chronic disease.
排除标准
- •Medical conditions or treatments affecting hormonal regulation.
- •Endocrine disorders, gynecological or reproductive health conditions.
- •Use of hormonal contraceptives or hormone therapy.
- •Recent major illness or surgery.
- •Severe allergies or hypersensitivities.
结局指标
主要结局
Hormone Levels Blood Panel (estradiol, testosterone, DHEA, insulin, and progesterone)
时间窗: Baseline (Day 0), Midline (Day 45), and Endline (Day 90)
Measurement of hormone levels. Blood tests will be conducted to evaluate these levels at Baseline (Day 2-5 of the first menstrual period), Midline (Day 2-5 of the second menstrual period), and Endline (Day 2-5 of the third menstrual period).
次要结局
- Participants' Perceptions of Quality of Life(Baseline (Day 0), Midline (Day 45), and Endline (Day 90))
- Participants' Mood and Energy Levels using the Visual Analog Scale (VAS)(Baseline (Day 0), Midline (Day 45), and Endline (Day 90))
- Participants' Monthly Cycle Symptoms using the Menstrual Cycle Symptom Diary (MCSD)(Baseline (Day 0), Midline (Day 45), and Endline (Day 90))
- Participants' Libido using a Libido Questionnaire(Baseline (Day 0), Midline (Day 45), and Endline (Day 90))