Fatigue, Menstrual Cramps, Women's Health
Conditions
Keywords
Menstrual Health, Period Symptoms
Brief summary
This clinical study aims to evaluate the effectiveness of My Happy Flo, a dietary supplement, in alleviating period symptoms and heavy menstrual flows. The study involves 40 participants, who will take the supplement daily for three menstrual cycles. Primary outcomes, such as the severity of heavy flows, prolonged periods, cramps, mood, energy levels, cycle regulation, and fatigue, will be measured using validated questionnaires completed after each menstrual cycle. Secondary outcomes, including Vitamin D and Iron levels, will be assessed through blood tests at the beginning and end of the study period.
Interventions
DIETARY_SUPPLEMENTMy Happy Flo
The intervention aims to alleviate period symptoms including heavy flows, prolonged periods, cramps, mood disturbances, energy levels, cycle regulation, and fatigue. Blood tests for Vitamin D and Iron levels will be conducted at Baseline and after the third menstrual cycle. Participants will complete validated questionnaires assessing period symptoms after each menstrual cycle.
Sponsors
Citruslabs
My Happy Flo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Female, aged 18 or over * Experiencing heavy period flows * Two or more self-reported symptoms (prolonged periods, cramps, poor mood, fatigue, irregular cycle) * Signs of potential anemia or iron deficiency * No known allergies to the product ingredients * Willing to comply with study requirements and limit caffeine intake * Generally healthy - do not live with any uncontrolled chronic disease
Exclusion criteria
* Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders * A diagnosis of sports anemia within the previous 6 months * Anyone with known severe allergic reactions that require an Epi-Pen * Women who are pregnant, breastfeeding, or trying to conceive * Anyone unwilling to follow the study protocol * Anyone who has undergone any surgeries or invasive treatments (such as immunotherapy, chemotherapy, radiation, or biological cancer) in the last 30 days or has any planned for the next 12 weeks * Anyone with a history of substance abuse * Anyone currently participating or planning to participate in a research study * Anyone taking prescription anticonvulsants (anti-seizure medications) * Anyone taking prescription anticoagulant medications (blood thinners) * Anyone taking any hormone-modulating medications (e.g., hormonal birth control, hormone replacement therapy, testosterone, tamoxifen, thyroid medications, etc.) * History of hysterectomy, oophorectomy, or other surgery to the reproductive organs * History of gynecologic cancer, such as cervical, ovarian, uterine, vaginal, or vulvar cancer * Currently experiencing menopausal or perimenopausal symptoms * Changes or cessation of hormonal birth control in the last three months * Active or abnormal uterine/vaginal bleeding * Resides in RI, NY, NJ, or AZ
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Period Symptoms | Baseline (Day 0), Cycle 1, Cycle 2, and Cycle 3 - each Cycle is 28 days | Measurement of heavy flows, prolonged periods, cramps, mood disturbances, energy levels, cycle regulation, and fatigue using validated questionnaires. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Vitamin D Level | Baseline and Cycle 3 - each Cycle is 28 days | Assessment of Vitamin D level through blood tests. |
| Changes in Iron Level | Baseline and Cycle 3 - each Cycle is 28 days | Assessment of Iron level through blood tests. |
Countries
United States
Outcome results
None listed