Premenstrual Syndrome-PMSNCT07013539
Efficacy of a Food Supplement in Relieving Premenstrual Syndrome Symptoms
A study testing plant extract in people with Premenstrual Syndrome-PMS, run by Activ'inside at 6 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome-PMS
- What is being tested?
- plant extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 6 sitesItaly
- Study dates
- 1 Sep 2025to 15 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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) ***
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Complife Italia SRL - Corso San Maurizio 25
Biella, Pavia
Complife Italia S.r.l. - Via Mortara 171
Ferrara, Ferrare
Complife Italia S.r.l. - Via Signorelli 159,
Garbagnate Milanese, Milan
Complife Italia S.r.l. - Piazzale Siena 11
Milan, Milan
Nutratech S.r.l. - Via Francesco Todaro 20/22
Rende, Cosenza
Complife Italia SRL- Via Monsignor Angelini 21
San Martino Siccomario, Pavia
About this study
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
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
- Being tested
- plant extract, Placebo
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plant extractDietary supplement
hard shell capsule containing plant extract
PlaceboDietary supplement
hard shell capsule containing maltodextrine
| Study group | Role | What they receive |
|---|---|---|
| Active product | Active comparator | Hard shell capsule containing active compound. Receives: Dietary Supplement: plant extract |
| Control product | Placebo comparator | Hard shell capsule containing maltodextrine Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 4, 8, 12 weeks after supplementation
Secondary outcomes (1)
PHQ-4
The Patient Health Questionnaire-4 (PHQ-4) is a brief, validated tool for assessing depression and anxiety symptoms. It consists of a 2-item depression scale (PHQ-2) and a 2-item anxiety scale (GAD-2). Each item asks how often the individual has been bothered by specific issues over 2 weeks, with responses rated on a scale from 0 (not at all) to 3 (nearly every day). .
Measured: From enrollment to 4, 8, 12 weeks after supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start1 Sep 2025
- Primary completion15 May 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual Syndrome-PMSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Activ'inside
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Rita Mocciaro Specialist in Gynaecology, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013539
- Sponsor's protocol ID
- IT00011934/25 Versione n°03
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: confidential data
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07013539
- Acronym / sponsor ID
- IT00011934/25 Versione n°03
- Conditions
- Premenstrual Syndrome-PMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Activ'insideIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active product | Active comparator | Dietary Supplement: plant extractHard shell capsule containing active compound. |
| Control product | Placebo comparator | Dietary Supplement: PlaceboHard shell capsule containing maltodextrine |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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**
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plant extracthard shell capsule containing plant extract | Dietary supplement | Active product |
| Placebohard shell capsule containing maltodextrine | Dietary supplement | Control product |
Primary outcome
PAF-SF
Time frame: From enrollment to 4, 8, 12 weeks after supplementation
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.
1 secondary outcome
PHQ-4
Time frame: From enrollment to 4, 8, 12 weeks after supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No. confidential data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Rita Mocciaro Specialist in Gynaecology principal investigator
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing plant extract in people with Premenstrual Syndrome-PMS, run by Activ'inside at 6 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAF-SF (time frame: From enrollment to 4, 8, 12 weeks after supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.