NCT07013539

Efficacy of a Food Supplement in Relieving Premenstrual Syndrome Symptoms

Clinical Evaluation of the Efficacy of a Food Supplement in Relieving Premenstrual Syndrome (PMS) Symptoms: a Randomized, Double-blind, Parallel-group, Placebo-controlled Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Activ'inside · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The aim of this clinical trial, funded by Activ'Inside, is to evaluate the efficacy of a food supplement in relieving Premenstrual Syndrome (PMS) Symptoms. The study will be performed on 110 healthy women who experience mild/moderate Premenstrual Syndrome (PMS) symptoms, under the supervision of a board-certified Gynecologist. Half of the subjects will assume the active product and half of the subjects will assume a placebo (a product without active ingredients). Specific assessments will be carried out before and after 1, 2 and 3 menstrual cycles of product intake. Also, the possible occurrence of adverse events will be recorded.

Conditions

• Premenstrual Syndrome-PMS

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	plant extract	hard shell capsule containing plant extract
DIETARY_SUPPLEMENT	Placebo	hard shell capsule containing maltodextrine

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-06-10
• Last updated: 2026-01-15

Locations

6 sites across 1 country: Italy