Clinical trial NCT07013539: Efficacy of a Food Supplement in Relieving Premenstrual Syndrome Symptoms
Official title: Clinical Evaluation of the Efficacy of a Food Supplement in Relieving Premenstrual Syndrome (PMS) Symptoms: a Randomized, Double-blind, Parallel-group, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Premenstrual Syndrome-PMS
Lead sponsor: Activ'inside
Sponsor class: INDUSTRY
First posted: 2025-06-10
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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
* Stable pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) for at least one month without any changes expected or planned during the study
* 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.

Exclusion Criteria:

* Subjects who do not meet the inclusion criteria
* 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).

    * Anti-depressants, anxiolytics, diuretics, hormonal contraceptives, nonsteroidal anti-inflammatory drugs.

Primary outcomes:
measure: PAF-SF
timeFrame: From enrollment to 4, 8, 12 weeks after supplementation
Secondary outcomes:
measure: PHQ-4
timeFrame: From enrollment to 4, 8, 12 weeks after supplementation
Other outcomes:
measure: Self-evaluation questionnaire
timeFrame: From enrollment to the end of the treatment at 12 weeks
Locations:
city: Rende
country: Italy
facility: Nutratech S.r.l. - Via Francesco Todaro 20/22
state: Cosenza
city: Ferrara
country: Italy
facility: Complife Italia S.r.l. - Via Mortara 171
state: Ferrare
city: Garbagnate Milanese
country: Italy
facility: Complife Italia S.r.l. - Via Signorelli 159,
state: Milan
city: Milano
country: Italy
facility: Complife Italia S.r.l. - Piazzale Siena 11
state: Milan
city: Biella
country: Italy
facility: Complife Italia SRL - Corso San Maurizio 25
state: Pavia
city: San Martino Siccomario
country: Italy
facility: Complife Italia SRL- Via Monsignor Angelini 21
state: Pavia
Study officials:
name: Dr. Rita Mocciaro Specialist in Gynaecology
role: PRINCIPAL_INVESTIGATOR
References: