A Single Group Study to Evaluate the Effects of a Myo-Inositol and D-Chiro Inositol Supplement on Symptoms Associated With Polycystic Ovary Syndrome and Hormone Imbalance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in menstrual cycle regularity. [Timeframe: Baseline to Week 12]
研究概览
简要总结
This is a virtual single group study that will last 12 weeks. 40 female participants will take 4 capsules of the Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplement per day. Questionnaires will be completed at Baseline, Week 4, Week 8 and Week 12. Participants will also provide a waist circumference measurement at Baseline and Week 12.
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
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged between 18 - 55
- •BMI less than 35
- •Self-reported symptoms of PCOS like irregular periods, excessive hair growth, weight gain, oily skin, or acne
- •Self-reported concerns around irregular menstrual cycles and ovulation, mood swings, stress, irritability, and low energy
- •Self-reported concerns with hormonal skin issues
- •Has access to a tape measure for waist measurement
- •Generally healthy - don't live with any uncontrolled chronic disease
排除标准
- •Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
- •Anyone with known severe allergic reactions
- •Anyone who is pregnant or breastfeeding
- •Unwilling to follow the study protocol
结局指标
主要结局
Changes in menstrual cycle regularity. [Timeframe: Baseline to Week 12]
时间窗: 12 weeks
Measured via study-specific questionnaires with participants reporting menstrual cycle occurrence and regularity during the trial.
Changes in hormonal skin issues. [Timeframe: Baseline to Week 12]
时间窗: 12 weeks
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
Changes in excessive body hair or facial hair. [Timeframe: Baseline to Week 12]
时间窗: 12 weeks
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
Changes in severity of menstrual cramps. [Timeframe: Baseline to Week 12]
时间窗: 12 weeks
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
次要结局
- Changes in sleep quality. [Timeframe: Baseline to Week 12](12 weeks)
- Changes in energy. [Timeframe: Baseline to Week 12](12 weeks)
- Changes in mood. [Timeframe: Baseline to Week 12](12 weeks)
- Changes in stress. [Timeframe: Baseline to Week 12](12 weeks)
- Changes in food cravings. [Timeframe: Baseline to Week 12](12 weeks)