Status:
COMPLETED
A Study to Assess the Effect of My Happy Flo on Alleviating Period Symptoms and Heavy Flows.
Lead Sponsor:
My Happy Flo
Collaborating Sponsors:
Citruslabs
Conditions:
Menstrual Cramps
Women's Health
Eligibility:
FEMALE
18+ years
Phase:
NA
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 tak...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06522672
Start Date
May 31 2024
End Date
August 31 2024
Last Update
November 20 2024
Active Locations (1)
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1
Citruslabs
Santa Monica, California, United States, 90404