An Exploratory Investigation of Dietary Supplementation and the Effect on the Regularity of Menstrual Cycles, Hormone Balance, and Common PMS Symptoms in Females
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Premama Inc.
- 主要终点
- Return to perceived regular/normal menstrual cycle
研究概览
简要总结
An investigation of the dietary supplement marketed as "Premama Balance" on markers of subjective wellbeing in trial participants such as common symptoms of PMS and menstrual symptoms, as well as its effects on aiding in returning to their perceived regular/normal menstrual cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Must be in good health (don't report any medical conditions asked in the screening questionnaire)
- •Must be on hormonal birth control (containing both progesterone and estrogen) for the past 6 months & willing to stop using it to participate in the study
- •Must be willing to get off of hormonal birth control for the study period
- •Must be able to track their menstrual cycle
- •BMI under 40
- •Agree to refrain from any lifestyle changes that may affect their menstrual cycle for the duration of the study
- •Willingness to adhere to the dietary supplement regimen
- •Willingness to refrain from any other dietary supplements targeting the menstrual cycle and hormone control during the study period
- •Is able to communicate in English
- •Is willing and able to share feedback via the used technology portal
- •Must provide written informed consent (ICF)
排除标准
- •History of oncological (including ovarian cancer) or psychiatric conditions
- •History of uncontrolled health conditions
- •History of hysterectomy or ovariectomy
- •History of diabetes & thyroid disorders
- •More than 3 servings of alcohol a day
- •Undergoing hormonal therapy of any kind
- •Menopausal or peri-menopausal
- •Not starting any other form of contraceptive other than condoms, abstinence, planned sexual intercourse
- •Usage of any medication or herbal remedies/supplements which can affect the menstrual cycle or hormonal balance
- •If currently taking allowed supplements, the dosage needs to remain the same throughout the entirety of the study
研究组 & 干预措施
PreMama Balance
Each day, the participants will take 1 packet of Premama Balance, dissolved in one glass (8oz+) of water. Premama Balance may be taken with or without food. Should participants present themselves with a sensitive stomach, it is recommended to take the drink with or after a meal to avoid an upset stomach. Participants will repeat this process daily for 6 months/24 weeks (study period) until the study is complete.
At week 12 and in week 24, the participants will take a survey and a hormone test to track progress. In total there will be 3 surveys and 3 hormone tests. Additionally, participants will fill out a weekly consumption survey to track compliance.
干预措施: PreMama Balance (Dietary Supplement)
Placebo Drink
Each day, the participants will take 1 packet of Placebo Drink, dissolved in one glass (8oz+) of water. Placebo Drink may be taken with or without food. Should participants present themselves with a sensitive stomach, it is recommended to take the drink with or after a meal to avoid an upset stomach. Participants will repeat this process daily for 6 months/24 weeks (study period) until the study is complete.
At week 12 and in week 24, the participants will take a survey and a hormone test to track progress. In total there will be 3 surveys and 3 hormone tests. Additionally, participants will fill out a weekly consumption survey to track compliance.
干预措施: Placebo Drink (Dietary Supplement)
结局指标
主要结局
Return to perceived regular/normal menstrual cycle
时间窗: 6 Months
Survey Based Assessment of changes in menstrual cycle
Changes in PMS and Menstrual Symptoms: Cramps, Bloating, Mood swings
时间窗: 6 Months
Survey-based assessment of changes in PMS and Menstrual symptoms
次要结局
未报告次要终点