Hormone Disturbance, Menstrual Discomfort, Menstrual Irregularity, Menstrual Pain, PMS
Conditions
Keywords
PMS, Menstrual Discomfort, Hormone Disturbance, Menstrual Pain, Menstrual Irregularity
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTPreMama Balance
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.
DIETARY_SUPPLEMENTPlacebo Drink
Blended Placebo drink
Sponsors
Citruslabs
Premama Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 42 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Return to perceived regular/normal menstrual cycle | 6 Months | Survey Based Assessment of changes in menstrual cycle |
| Changes in PMS and Menstrual Symptoms: Cramps, Bloating, Mood swings | 6 Months | Survey-based assessment of changes in PMS and Menstrual symptoms |
Outcome results
None listed