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

NCT ID: NCT05237661

Last Updated: 2022-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-15

Study Completion Date

2022-05-31

Brief Summary

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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

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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.

Conditions

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PMS Menstrual Discomfort Menstrual Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dietary supplement

Dietary supplement: Moon Balance

Group Type EXPERIMENTAL

Moon Balance

Intervention Type DIETARY_SUPPLEMENT

Moon Balance is a blend of 6 food ingredients

Interventions

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Moon Balance

Moon Balance is a blend of 6 food ingredients

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Citruslabs

INDUSTRY

Sponsor Role collaborator

Your Super, INC.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susanne Mitschke

Role: PRINCIPAL_INVESTIGATOR

Citruslabs

Locations

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Citruslabs

Santa Monica, California, United States

Site Status

Countries

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United States

Other Identifiers

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20230MoonBalance

Identifier Type: -

Identifier Source: org_study_id

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