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Completed

NCT Number: NCT05237661

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

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.

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Key information

Conditions

PMS Dysmenorrhea Menstrual Discomfort Menstrual Pain Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moon Balance

Dietary Supplement

Moon Balance is a blend of 6 food ingredients

Primary outcomes

  1. Change in perceived discomfort associated with menstruation

    Time frame: 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 outcomes

  1. Change in blood biomarkers: C-reactive protein

    Time frame: 12 weeks

    Change in C-Reactive Protein (CRP) with an at-home blood test after 12 weeks compared to baseline results.

  2. Changes in saliva cortisol levels

    Time frame: 12 weeks

    Change in saliva cortisol levels with an at-home test after 12 weeks compared to baseline results.

Sponsors and collaborators

Lead sponsor

Your Super, INC.

Industry

Collaborators

  • Citruslabs

Registry information

Official study title

Study to Evaluate the Efficacy of Your Super's Moon Balance and Its Impact on Premenstrual Syndrome and Menstrual Symptoms

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 14, 2022
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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