Study to Evaluate Your Super's Moon Balance and Its Impact on Premenstrual Syndrome

Not Applicable

Completed

• Conditions: Menstrual Pain; Menstrual Discomfort; PMS

• Registration Number: NCT05237661
• Lead Sponsor: Your Super, INC.

Brief Summary

This is an open-label observational single-group clinical trial to study the efficacy of a commercially available dietary supplement and its effect on common PMS and menstrual symptoms, as well as health-related biomarkers.

Detailed Description

It is hypothesized that the dietary supplement marketed as "YOUR SUPER Moon Balance" will improve subjective wellbeing in trial participants by alleviating common symptoms of PMS and menstrual symptoms, such as pain, cramps, bloating, and lack of energy. Further, the ability of the supplement to reduce biomarkers of inflammation (CRP) and stress (cortisol), and promote sleep, will be evaluated.

Study Timeline

• Study First Submitted: 2022-02-02
• Study First Submitted QC: 2022-02-02
• Study First Posted: 2022-02-14
• Study Start: 2022-02-15
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-16
• Last Update Posted: 2022-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

Inclusion Criteria

• Individuals with a regular menstruation
• Age 18-40
• Moderate self-reported discomfort during menstruation-related to bloating, cramps, fatigue, mood swings, or other PMS-related symptoms
• Must be in generally good health - no unstable, uncontrolled health condition
• BMI under 35
• Self-reported sleep-issues
• Willingness to refrain from ibuprofen or naproxen sodium (such as Advil, Aleve, Motrin or Midol) during each period (pill bleed) during the study
• Agree to not change their diet significantly during the duration of the study
• Agree to not change the intensity of their workouts for the duration of the study
• Must get their period regularly

Exclusion Criteria

• Severe chronic conditions, including oncological and psychiatric disorders
• Known to have any severe allergic reactions
• Currently pregnant, breastfeeding, or wanting to become pregnant for the duration of the study
• Participants unwilling to follow the study protocol
• Have used a similar product (ingredients) in the 6 weeks prior to the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in perceived discomfort associated with menstruation	12 weeks	Perceived discomfort caused by several of the most common menstrual symptoms (energy, sleep, mood, comfort, and overall fewer PMS symptoms); Each endpoint will be reported by the participant on a scale of perceived discomfort at the end of each menstrual cycle. Participants will complete the surveys for each menstrual cycle. The study uses a questionnaire including a scale from 0-7 to assess the severity of symptoms(0=no symptoms and 7=very severe symptoms).

Secondary Outcome Measures

Name	Time	Method
Changes in saliva cortisol levels	12 weeks	Change in saliva cortisol levels with an at-home test after 12 weeks compared to baseline results.
Change in blood biomarkers: C-reactive protein	12 weeks	Change in C-Reactive Protein (CRP) with an at-home blood test after 12 weeks compared to baseline results.

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States