Efficacy of a Food Supplement in Relieving Premenstrual Syndrome Symptoms

NCT07013539 | Active Not Recruiting

• 1 other identifier: IT00011934/25 Versione n°03
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (1)

• PAF-SF

  The Premenstrual Assessment Form Short Form (PAF-SF) is a standardized questionnaire designed to evaluate the severity and impact of premenstrual syndrome (PMS) symptoms. The total score can range from 10 to 60 points, with higher scores indicating greater severity of symptoms.

  From enrollment to 4, 8, 12 weeks after supplementation

Secondary Outcomes (1)

• PHQ-4

  From enrollment to 4, 8, 12 weeks after supplementation

Other Outcomes (1)

• Self-evaluation questionnaire

  From enrollment to the end of the treatment at 12 weeks

Study Arms (2)

Active product

ACTIVE COMPARATOR

Hard shell capsule containing active compound.

Dietary Supplement: plant extract

Control product

PLACEBO COMPARATOR

Hard shell capsule containing maltodextrine

Dietary Supplement: Placebo

Interventions

plant extract DIETARY_SUPPLEMENT

hard shell capsule containing plant extract

Active product

Placebo DIETARY_SUPPLEMENT

hard shell capsule containing maltodextrine

Control product

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy female subjects
• Caucasian ethnicity
• Subjects of childbearing age, between 18 and 45 years (extremes included)
• Subjects who experience mild/moderate Premenstrual Syndrome (PMS) symptoms for at least 3 menstrual cycles prior the beginning of the experimental phase of the study\*
• Subjects who have regular menstrual cycles: 21- to 35-day intervals between two menstrual cycles and a menstrual flow duration of 2-8 days\*\*
• Normal weight (BMI greater than or equal to 18.5 to 24.9 kg/m2) \*\*\*
• Subjects registered with National Health Service (NHS)
• Subjects certifying the truthfulness of the personal data disclosed to the investigator
• Subjects able to understand the language used in the investigation centre and the information given by the investigator
• Subjects able to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements
• Commitment not to change the daily routine or the lifestyle
• Subjects informed about the test procedures who have signed a consent form.
• Assessed by the psychologist using the Premenstrual Symptoms Screening Tool (PSST), a validated self-assessment questionnaire designed to identify women experiencing Premenstrual Syndrome (PMS). The PSST includes questions addressing physical, psychological, and behavioural symptoms. Participants will complete the questionnaire for three consecutive months, and the psychologist will confirm whether they suffer from mild to moderate PMS.
• Verified by a diary in which participants record this information. Subjects complete the diary for three consecutive months.
• According to the World Health Organization (WHO) BMI Classification.

You may not qualify if:

• Subjects in the perimenopausal period
• Subjects with any acute, chronic, or progressive disease or condition that may interfere with the study data or that the investigator considers dangerous to the subject or incompatible with the requirements of the study\*\*\*\*
• Subjects participating or planning to participate in other clinical trials
• Subjects who participated in a similar study without respecting an adequate washout period (at least one month)
• Subjects that have food intolerances or food allergies to ingredients of the study product
• Subjects under pharmacological treatments that are considered incompatible with the study requirement by the investigator\*\*\*\*\*
• Subjects who are currently using food supplement(s) and/or products with the same activity as the study product, or who haven't observed an adequate washout period (at least one month)
• Subjects admitted to a health or social facility
• Subjects planning a hospitalization during the study
• Subjects not able to be contacted in case of emergency
• Subjects deprived of freedom by administrative or legal decision or under guardianship
• Subjects with a history of drug, alcohol and other substance abuse
• Subjects with eating disorders (i.e. bulimia, psychogenic eating disorders, etc.)
• Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential).
• Polycystic ovary syndrome, endometriosis, thyroid disease, chronic fatigue syndrome, irritable bowel syndrome (IBS), psychiatric disorder (including depression, anxiety, bipolar).

Sponsors & Collaborators

• Activ'inside: lead

Study Sites (6)

Nutratech S.r.l. - Via Francesco Todaro 20/22

Rende, Cosenza, Italy

Location

Complife Italia S.r.l. - Via Mortara 171

Ferrara, Ferrare, Italy

Location

Complife Italia S.r.l. - Via Signorelli 159,

Garbagnate Milanese, Milan, Italy

Location

Complife Italia S.r.l. - Piazzale Siena 11

Milan, Milan, Italy

Location

Complife Italia SRL - Corso San Maurizio 25

Biella, Pavia, Italy

Location

Complife Italia SRL- Via Monsignor Angelini 21

San Martino Siccomario, Pavia, Italy

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Plant Extracts

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Pharmaceutical Preparations

Study Officials

• Dr. Rita Mocciaro Specialist in Gynaecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 10, 2025
• Study Start: September 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (6)