New supplement aims to tame monthly PMS misery
NCT ID NCT07013539
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a food supplement can reduce the discomfort of premenstrual syndrome (PMS) in 110 healthy women aged 18 to 45 with mild to moderate symptoms. Half took the supplement and half took a placebo for three menstrual cycles. Researchers tracked symptom severity using questionnaires and recorded any side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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110 people
The number who actually took part.
- Started
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Sep 2025
- Finished
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May 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Complife Italia S.r.l. - Piazzale Siena 11
Milan, Milan, Italy
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Complife Italia S.r.l. - Via Mortara 171
Ferrara, Ferrare, Italy
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Complife Italia S.r.l. - Via Signorelli 159,
Garbagnate Milanese, Milan, Italy
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Complife Italia SRL - Corso San Maurizio 25
Biella, Pavia, Italy
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Complife Italia SRL- Via Monsignor Angelini 21
San Martino Siccomario, Pavia, Italy
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Nutratech S.r.l. - Via Francesco Todaro 20/22
Rende, Cosenza, Italy
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could classmates' advice ease PMS symptoms? a trial puts peer education to the test
- Can laughter yoga beat PMS? small study says yes
- Seed cycling: a natural approach to ease PMS symptoms?
- Eating smart to beat PMS: study tests nutrition lessons for college women
- Simple relaxation methods show promise for PMS relief