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

NCT05237661 | Completed

• 1 other identifier: 20230MoonBalance
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

PMS; Menstrual Discomfort; Menstrual Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in blood biomarkers: C-reactive protein

  12 weeks

• Changes in saliva cortisol levels

  12 weeks

Study Arms (1)

Dietary supplement

EXPERIMENTAL

Dietary supplement: Moon Balance

Dietary Supplement: Moon Balance

Interventions

Moon Balance DIETARY_SUPPLEMENT

Moon Balance is a blend of 6 food ingredients

Dietary supplement

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Your Super, INC.: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Susanne Mitschke

  Citruslabs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 14, 2022
• Study Start: February 15, 2022
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Locations

US (1)