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

NCT06522672 | Completed

• 1 other identifier: 20436
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Menstrual Cramps; Women's Health; Fatigue

Keywords

Menstrual Health; Period Symptoms

Outcome Measures

Primary Outcomes (1)

• Improvement in Period Symptoms

  Measurement of heavy flows, prolonged periods, cramps, mood disturbances, energy levels, cycle regulation, and fatigue using validated questionnaires.

  Baseline (Day 0), Cycle 1, Cycle 2, and Cycle 3 - each Cycle is 28 days

Secondary Outcomes (2)

• Changes in Vitamin D Level

  Baseline and Cycle 3 - each Cycle is 28 days

• Changes in Iron Level

  Baseline and Cycle 3 - each Cycle is 28 days

Study Arms (1)

My Happy Flo Supplement

EXPERIMENTAL

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.

Dietary Supplement: My Happy Flo

Interventions

My Happy Flo DIETARY_SUPPLEMENT

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.

My Happy Flo Supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• My Happy Flo: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Dysmenorrhea; Fatigue

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 26, 2024
• Study Start: May 31, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)