A Study to Assess the Effect of My Happy Flo on Alleviating Period Symptoms and Heavy Flows.

My Happy Flo

Status: Completed

Conditions: Menstrual Cramps; Women's Health; Fatigue

Treatments: Dietary Supplement: My Happy Flo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06522672

20436

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

My Happy Flo Supplement

Experimental group

Description:

Participants will take two capsules of My Happy Flo daily, preferably in the morning with 8-10 oz of water and a meal, for three menstrual cycles.

Treatment:

Dietary Supplement: My Happy Flo