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

Menstrual Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05237661
• Other study ID #: 20230MoonBalance
• Status: Completed
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: May 31, 2022

Study information

• Verified date: June 2022
• Source: Your Super, INC.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysmenorrhea
• Menstrual Discomfort
• Menstrual Pain
• PMS
• Premenstrual Syndrome

Intervention

Dietary Supplement:
• Moon Balance
Moon Balance is a blend of 6 food ingredients

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Your Super, INC.	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in perceived discomfort associated with menstruation	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).	12 weeks
Secondary	Change in blood biomarkers: C-reactive protein	Change in C-Reactive Protein (CRP) with an at-home blood test after 12 weeks compared to baseline results.	12 weeks
Secondary	Changes in saliva cortisol levels	Change in saliva cortisol levels with an at-home test after 12 weeks compared to baseline results.	12 weeks