Efficacy of a Food Supplement in Relieving Premenstrual Syndrome Symptoms

NCT07013539 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-01-15

No results posted yet for this study

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

DIETARY_SUPPLEMENT

plant extract

hard shell capsule containing plant extract

DIETARY_SUPPLEMENT

Placebo

hard shell capsule containing maltodextrine

Sponsors & Collaborators

  • Activ'inside

    lead INDUSTRY

Principal Investigators

  • Dr. Rita Mocciaro Specialist in Gynaecology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-05-01
Completion
2026-05-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07013539 on ClinicalTrials.gov