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

Your Super

Status: Completed

Conditions: Menstrual Pain; PMS; Menstrual Discomfort

Treatments: Dietary Supplement: Moon Balance

Study type: Interventional

Funder types: Industry

Identifiers

NCT05237661

20230MoonBalance

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Dietary supplement

Experimental group

Description:

Dietary supplement: Moon Balance

Treatment:

Dietary Supplement: Moon Balance