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

NCT ID: NCT06522672

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-31

Study Completion Date

2024-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Menstrual Cramps Women's Health Fatigue

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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My Happy Flo Supplement

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.

Group Type EXPERIMENTAL

My Happy Flo

Intervention Type 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.

Interventions

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My 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Citruslabs

INDUSTRY

Sponsor Role collaborator

My Happy Flo

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Citruslabs

Santa Monica, California, United States

Site Status

Countries

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United States

Other Identifiers

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20436

Identifier Type: -

Identifier Source: org_study_id

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