A Study to Evaluate the Effect of Funk It Cycle Bites on PMS

Funk It Wellness

Status

Completed

Conditions

Premenstrual Syndrome

Treatments

Other: Funk It Cycle Bites

Study type

Interventional

Funder types

Industry

Identifiers

NCT05900024

FunkItWellness

Details and patient eligibility

About

This is a virtual, open-label, single-group study that will last 4 menstrual cycles. All participants will complete a questionnaire at the end of their first period after enrolling (baseline/non-intervention cycle 1), then proceed to take the product daily and complete questionnaires at the end of their next 3 periods (intervention cycles 1, 2, and 3). The study will involve 30 female participants with regular menstrual cycles who experience PMS.

Questionnaires will be used to monitor menstrual pain/cramps, energy levels, mood, and hormonal acne experienced before and during the menstrual cycle. Likert scale responses will be statistically compared from baseline to each check-in. Participant responses on product feedback will be presented as % scores.

Enrollment

30 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Female aged 18-40
Have a regular menstrual cycle (every 21-35 days).
Suffer from mild to moderate menstrual pain.
May experience mood swings and/or hormonal acne related to the menstrual cycle.
Otherwise generally healthy.
Willing to consume the test product with a ginger flavor.
Willing to refrain from taking any other supplements or prescription medications that may target the menstrual cycle or premenstrual syndrome (PMS) symptoms throughout the study period.
Willing and able to adhere to the study protocol, including taking supplements at the required times and completing questionnaires via the technology portal.
Able to communicate in English.
Participants must provide written informed consent (ICF).

Exclusion criteria

Any unstable or uncontrolled medical or psychiatric illness.
Any uncontrolled chronic disease or condition that would prevent full participation in the study protocol.
A history of polycystic ovary syndrome (PCOS), endometriosis, premenstrual dysphoric disorder (PMDD), or undiagnosed vaginal bleeding.
Are taking hormonal contraception or exogenous sex hormones (estrogen, testosterone, progesterone), or have taken hormonal contraception or exogenous hormones in the past 6 months.
Are taking any prescription medication or supplements that target the menstrual cycle or PMS symptoms.
Are pregnant, breastfeeding, trying to become pregnant, or have been pregnant in the past 12 months.
Have any known severe allergic reactions, or any allergies of any severity to any of the test product's ingredients.