NCT06763809

A Randomized Placebo-Controlled Study to Evaluate the Effects of a Gummy and Capsule Supplement on Symptoms of Premenstrual Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Semaine Health · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This virtual, randomized, placebo-controlled clinical trial evaluates the effectiveness of a PMS capsule and PMS gummy in alleviating premenstrual syndrome symptoms over 12 weeks. Participants will be divided into four groups, receiving either the PMS capsule, capsule placebo, PMS gummy, or gummy placebo. Efficacy will be assessed using validated questionnaires.

Conditions

• PMS
• Menstrual Cramp
• Mood Change

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	PMS Capsule	Participants will take 2 capsules, 4 times daily, starting at the onset of PMS symptoms and continuing until symptoms subside.
DIETARY_SUPPLEMENT	Capsule Placebo	Participants will take 2 capsules, 4 times daily, starting at the onset of PMS symptoms and continuing until symptoms subside.
DIETARY_SUPPLEMENT	PMS Gummy	Participants will take 2 gummies, 4 times daily, starting at the onset of PMS symptoms and continuing until symptoms subside.
DIETARY_SUPPLEMENT	Gummy Placebo	Participants will take 2 gummies, 4 times daily, starting at the onset of PMS symptoms and continuing until symptoms subside.

Timeline

• Start date: 2024-09-04
• Primary completion: 2024-12-12
• Completion: 2024-12-12
• First posted: 2025-01-08
• Last updated: 2025-01-08

Locations

1 site across 1 country: United States