NCT05145257

Study to Evaluate the Efficacy of Elix's Cycle Balance and Its Impact on PMS and Menstrual Symptoms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Zenchi, Inc. · Industry
• Sex: Female
• Age: 18 Years – 36 Years
• Healthy volunteers: Accepted

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. It is hypothesized that the dietary supplement marketed as "Elix Cycle Balance" will improve subjective wellbeing in trial participants by alleviating common symptoms of PMS and menstrual symptoms, such as cramps, bloating, and mood swings. A total of 65 participants will be recruited for the trial following screening, with the expectation that at least 50 participants will complete the trial. The trial will be fully remote, a technology platform will be utilized to screen, enroll and capture study data of the participants. The total intervention study period will be 3 months.

Conditions

• PMS
• Menstrual Pain

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Elix Cycle Balance	Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance

Timeline

• Start date: 2022-01-05
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2021-12-06
• Last updated: 2025-01-01
• Results posted: 2025-01-01

Locations

1 site across 1 country: United States