An Investigation of Premama Balance and Its Effects on Hormonal Imbalances

Study Overview
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Brief Summary
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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.

Official Title
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An Exploratory Investigation of Dietary Supplementation and the Effect on the Regularity of Menstrual Cycles, Hormone Balance, and Common PMS Symptoms in Females

Conditions
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Menstrual Pain, PMS, Menstrual Discomfort, Hormone Disturbance, Menstrual Irregularity

Intervention / Treatment
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* Dietary Supplement: PreMama Balance
* Dietary Supplement: Placebo Drink


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: History of oncological (including ovarian cancer) or psychiatric conditions History of uncontrolled health conditions History of hysterectomy or ovariectomy History of diabetes & thyroid disorders Smoker 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PreMama Balance<br>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. | Dietary Supplement: PreMama Balance<br>* Premama Balance is a blend of the following: Vitex (Chasteberry Extract), commonly used to help regulate hormones; Antioxidants, Selenium, and Magnesium, also help support the cleansing of hormonal birth control from the liver and help strengthen the uterine lining.<br>|
| Placebo Comparator: Placebo Drink<br>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. | Dietary Supplement: Placebo Drink<br>* Blended Placebo drink<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to perceived regular/normal menstrual cycle | Survey Based Assessment of changes in menstrual cycle | 6 Months | 
| Changes in PMS and Menstrual Symptoms: Cramps, Bloating, Mood swings | Survey-based assessment of changes in PMS and Menstrual symptoms | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PMS, Menstrual Discomfort, Hormone Disturbance, Menstrual Pain, Menstrual Irregularity