Polycystic Ovary SyndromeNCT07465575
Berberine Phytosome for Signs and Symptoms of Polycystic Ovary Syndrome (PCOS)
A study testing Berberine Phytosome (Sophy®) and Lifestyle Advice in people with Polycystic Ovary Syndrome, run by Liaquat University of Medical & Health Sciences at 1 site in Italy.
Trial summary
This multicenter, randomized, controlled clinical trial aims to evaluate the effectiveness of berberine phytosome supplementation in improving signs and symptoms associated with polycystic ovary syndrome (PCOS). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Berberine Phytosome (Sophy®) and Lifestyle Advice
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 16 Mar 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-40 years
- Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam criteria
- Body mass index (BMI) ≥ 25 kg/m²
- Evidence of insulin resistance (HOMA-IR above normal range)
- Willingness to follow lifestyle recommendations including dietary advice and physical activity
- Ability to provide written informed consent
Who cannot join
- Pregnancy or breastfeeding
- Use of insulin-sensitizing drugs (e.g., metformin) within the previous 3 months
- Current hormonal therapy including oral contraceptives or anti-androgens
- Diagnosis of diabetes mellitus
- Known liver, renal, cardiovascular, or endocrine diseases other than PCOS
- Use of berberine-containing supplements within the previous 3 months
- Known hypersensitivity to berberine or related compounds
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
University of Urbino Carlo Bo
Urbino
Prof. Davide, Sisti, PhD, davide.sisti@uniurb.it
About this study
Official title: Effectiveness of Berberine Phytosome in Improving Signs and Symptoms of Polycystic Ovary Syndrome (PCOS): A Multicentre, Randomized, Controlled Trial
This multicenter, randomized, controlled clinical trial aims to evaluate the effectiveness of berberine phytosome supplementation in improving signs and symptoms associated with polycystic ovary syndrome (PCOS). Women presenting with clinical features suggestive of PCOS, including hirsutism, acne, menstrual irregularities, and overweight, will be enrolled.
Participants will be randomly assigned to one of three groups: (1) berberine phytosome supplementation in women not previously taking inositol, (2) berberine phytosome supplementation in women already taking inositol for at least three months, or (3) a control group receiving lifestyle advice without supplementation. The intervention will consist of berberine phytosome 550 mg once daily for 12 weeks.
The study will evaluate changes in clinical manifestations associated with hyperandrogenism and metabolic dysfunction, including hirsutism, acne severity, body mass index, and metabolic parameters. The results will provide evidence on the potential role of berberine phytosome supplementation in improving clinical manifestations related to PCOS.
Read the detailed description
Polycystic ovary syndrome (PCOS) is a common endocrine and metabolic disorder affecting women of reproductive age and characterized by hyperandrogenism, menstrual irregularities, metabolic alterations, and dermatological manifestations such as acne and hirsutism. These clinical manifestations are often associated with insulin resistance and metabolic dysregulation.
Berberine is an isoquinoline alkaloid derived from several medicinal plants, including Berberis species, and has been reported to exert insulin-sensitizing, lipid-lowering, and metabolic regulatory effects. However, conventional berberine formulations have limited intestinal absorption and low systemic bioavailability. Berberine phytosome is a formulation designed to improve the bioavailability of berberine.
This study is designed as a prospective, multicenter, randomized, controlled clinical trial enrolling 150 women aged 18-40 years presenting with clinical signs suggestive of PCOS. Participants will be randomized into three parallel groups: (1) berberine phytosome supplementation in women who have never taken inositol, (2) berberine phytosome supplementation in women who have been taking inositol for at least three months, and (3) a control group receiving lifestyle advice without supplementation.
The intervention will consist of oral berberine phytosome 550 mg once daily for 12 weeks. All participants will receive lifestyle recommendations including dietary advice and encouragement of regular physical activity.
Primary outcomes include changes in clinical parameters associated with hyperandrogenism and metabolic status, including hirsutism (Ferriman-Gallwey score), acne severity (Cardiff Acne Disability Index), and body mass index. Secondary outcomes include metabolic parameters such as the HOMA index, waist circumference, blood pressure, hormonal profiles, lipid parameters, and quality of life assessments.
Safety will be evaluated through monitoring of adverse events during the study period. The results of this trial will help clarify the potential role of berberine phytosome supplementation in the management of clinical manifestations associated with PCOS.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Berberine Phytosome (Sophy®), Lifestyle Advice
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Berberine Phytosome (Sophy®)Dietary supplement
Also called Sophy® (PharmExtracta S.p.A., Italy)
Berberine phytosome administered orally at a dose of 550 mg once daily for 12 weeks. The formulation used in this study is Sophy® (PharmExtracta S.p.A., Italy), a nutraceutical preparation containing berberine designed to improve bioavailability.
Lifestyle AdviceBehavioural
Participants receive standardized lifestyle advice including dietary recommendations based on a Mediterranean diet and encouragement of regular physical activity such as brisk walking or cycling for approximately 30 minutes, three to five times per week.
| Study group | Role | What they receive |
|---|---|---|
| Berberine Phytosome (Inositol-Naïve) | Experimental | Participants receive berberine phytosome supplementation (550 mg once daily) for 12 weeks in women who have not previously taken inositol. Participants also receive lifestyle advice including dietary guidance and encouragement of regular physical activity. Receives: Dietary Supplement: Berberine Phytosome (Sophy®); Behavioral: Lifestyle Advice |
| Berberine Phytosome + Inositol | Experimental | Participants who have been taking inositol (myo-inositol or D-chiro-inositol) for at least three months receive berberine phytosome supplementation (550 mg once daily) for 12 weeks in addition to ongoing lifestyle advice including dietary guidance and regular physical activity. Receives: Dietary Supplement: Berberine Phytosome (Sophy®); Behavioral: Lifestyle Advice |
| Lifestyle Advice Only (Control) | Active comparator | Participants receive lifestyle advice including dietary guidance and recommendations for increased physical activity without berberine phytosome supplementation during the 12-week study period. Receives: Behavioral: Lifestyle Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ferriman-Gallwey Score (Hirsutism)
Assessment of change in hirsutism severity using the Ferriman-Gallwey scoring system, which evaluates terminal hair growth in nine body areas. Scores range from 0 to 36, with higher scores indicating more severe hirsutism.
Measured: Baseline to Week 12
Change in Cardiff Acne Disability Index (CADI) Score
Assessment of change in acne-related quality of life using the Cardiff Acne Disability Index (CADI), a validated 5-item questionnaire evaluating the psychological and social impact of acne. Scores range from 0 to 15, with higher scores indicating greater impairment.
Measured: Baseline to Week 12
Change in Body Mass Index (BMI)
Assessment of change in body mass index (BMI), calculated as body weight in kilograms divided by height in meters squared (kg/m²).
Measured: Baseline to Week 12
Secondary outcomes (5)
Change in HOMA-IR (Homeostatic Model Assessment for Insulin Resistance)
Assessment of the change in insulin resistance measured by the HOMA-IR index calculated from fasting glucose and fasting insulin concentrations.
Measured: Baseline to Week 12
Change in Waist Circumference
Assessment of changes in waist circumference as a marker of central adiposity.
Measured: Baseline to Week 12
Change in Blood Pressure
Assessment of changes in systolic and diastolic blood pressure measured using standard clinical procedures.
Measured: Baseline to Week 12
Change in Global Acne Grading System (GAGS) Score
Assessment of acne severity using the Global Acne Grading System (GAGS).
Measured: Baseline to Week 12
Change in Polycystic Ovary Syndrome Quality of Life Questionnaire (PCOSQ)
Assessment of changes in health-related quality of life using the Polycystic Ovary Syndrome Quality of Life Questionnaire (PCOSQ).
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start16 Mar 2026 (estimated)
- Primary completion19 Feb 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies 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
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups: (1) berberine phytosome supplementation in women who have never taken inositol, (2) berberine phytosome supplementation in women already taking inositol for at least three months, and (3) a control group receiving lifestyle advice without supplementation. The intervention duration will be 12 weeks.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Urbino "Carlo Bo"
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465575
- Sponsor's protocol ID
- 53_9dicembre2022_Berberine
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Berberine Phytosome in Improving Signs and Symptoms of Polycystic Ovary Syndrome (PCOS): A Multicentre, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT07465575
- Acronym / sponsor ID
- 53_9dicembre2022_Berberine
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Collaborators
- University of Urbino "Carlo Bo"
- Study start
- 16 Mar 2026 (estimated)
- Primary completion
- 19 Feb 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 12 Mar 2026 (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.
This multicenter, randomized, controlled clinical trial aims to evaluate the effectiveness of berberine phytosome supplementation in improving signs and symptoms associated with polycystic ovary syndrome (PCOS). Women presenting with clinical features suggestive of PCOS, including hirsutism, acne, menstrual irregularities, and overweight, will be enrolled.
Participants will be randomly assigned to one of three groups: (1) berberine phytosome supplementation in women not previously taking inositol, (2) berberine phytosome supplementation in women already taking inositol for at least three months, or (3) a control group receiving lifestyle advice without supplementation. The intervention will consist of berberine phytosome 550 mg once daily for 12 weeks.
The study will evaluate changes in clinical manifestations associated with hyperandrogenism and metabolic dysfunction, including hirsutism, acne severity, body mass index, and metabolic parameters. The results will provide evidence on the potential role of berberine phytosome supplementation in improving clinical manifestations related to PCOS.
Detailed description
Polycystic ovary syndrome (PCOS) is a common endocrine and metabolic disorder affecting women of reproductive age and characterized by hyperandrogenism, menstrual irregularities, metabolic alterations, and dermatological manifestations such as acne and hirsutism. These clinical manifestations are often associated with insulin resistance and metabolic dysregulation.
Berberine is an isoquinoline alkaloid derived from several medicinal plants, including Berberis species, and has been reported to exert insulin-sensitizing, lipid-lowering, and metabolic regulatory effects. However, conventional berberine formulations have limited intestinal absorption and low systemic bioavailability. Berberine phytosome is a formulation designed to improve the bioavailability of berberine.
This study is designed as a prospective, multicenter, randomized, controlled clinical trial enrolling 150 women aged 18-40 years presenting with clinical signs suggestive of PCOS. Participants will be randomized into three parallel groups: (1) berberine phytosome supplementation in women who have never taken inositol, (2) berberine phytosome supplementation in women who have been taking inositol for at least three months, and (3) a control group receiving lifestyle advice without supplementation.
The intervention will consist of oral berberine phytosome 550 mg once daily for 12 weeks. All participants will receive lifestyle recommendations including dietary advice and encouragement of regular physical activity.
Primary outcomes include changes in clinical parameters associated with hyperandrogenism and metabolic status, including hirsutism (Ferriman-Gallwey score), acne severity (Cardiff Acne Disability Index), and body mass index. Secondary outcomes include metabolic parameters such as the HOMA index, waist circumference, blood pressure, hormonal profiles, lipid parameters, and quality of life assessments.
Safety will be evaluated through monitoring of adverse events during the study period. The results of this trial will help clarify the potential role of berberine phytosome supplementation in the management of clinical manifestations associated with PCOS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups: (1) berberine phytosome supplementation in women who have never taken inositol, (2) berberine phytosome supplementation in women already taking inositol for at least three months, and (3) a control group receiving lifestyle advice without supplementation. The intervention duration will be 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Berberine Phytosome (Inositol-Naïve) | Experimental | Dietary Supplement: Berberine Phytosome (Sophy®), Behavioral: Lifestyle AdviceParticipants receive berberine phytosome supplementation (550 mg once daily) for 12 weeks in women who have not previously taken inositol. Participants also receive lifestyle advice including dietary guidance and encouragement of regular physical activity. |
| Berberine Phytosome + Inositol | Experimental | Dietary Supplement: Berberine Phytosome (Sophy®), Behavioral: Lifestyle AdviceParticipants who have been taking inositol (myo-inositol or D-chiro-inositol) for at least three months receive berberine phytosome supplementation (550 mg once daily) for 12 weeks in addition to ongoing lifestyle advice including dietary guidance and regular physical activity. |
| Lifestyle Advice Only (Control) | Active comparator | Behavioral: Lifestyle AdviceParticipants receive lifestyle advice including dietary guidance and recommendations for increased physical activity without berberine phytosome supplementation during the 12-week study period. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged 18-40 years
- Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam criteria
- Body mass index (BMI) ≥ 25 kg/m²
- Evidence of insulin resistance (HOMA-IR above normal range)
- Willingness to follow lifestyle recommendations including dietary advice and physical activity
Key exclusion criteria (7 listed)
- Pregnancy or breastfeeding
- Use of insulin-sensitizing drugs (e.g., metformin) within the previous 3 months
- Current hormonal therapy including oral contraceptives or anti-androgens
- Diagnosis of diabetes mellitus
- Known liver, renal, cardiovascular, or endocrine diseases other than PCOS
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 |
|---|---|---|
| Berberine Phytosome (Sophy®)Also: Sophy® (PharmExtracta S.p.A., Italy)Berberine phytosome administered orally at a dose of 550 mg once daily for 12 weeks. The formulation used in this study is Sophy® (PharmExtracta S.p.A., Italy), a nutraceutical preparation containing berberine designed to improve bioavailability. | Dietary supplement | Berberine Phytosome (Inositol-Naïve), Berberine Phytosome + Inositol |
| Lifestyle AdviceParticipants receive standardized lifestyle advice including dietary recommendations based on a Mediterranean diet and encouragement of regular physical activity such as brisk walking or cycling for approximately 30 minutes, three to five times per week. | Behavioural | Berberine Phytosome (Inositol-Naïve), Berberine Phytosome + Inositol, Lifestyle Advice Only (Control) |
Primary outcome
Change in Ferriman-Gallwey Score (Hirsutism)
Time frame: Baseline to Week 12
Assessment of change in hirsutism severity using the Ferriman-Gallwey scoring system, which evaluates terminal hair growth in nine body areas. Scores range from 0 to 36, with higher scores indicating more severe hirsutism.
Change in Cardiff Acne Disability Index (CADI) Score
Time frame: Baseline to Week 12
Assessment of change in acne-related quality of life using the Cardiff Acne Disability Index (CADI), a validated 5-item questionnaire evaluating the psychological and social impact of acne. Scores range from 0 to 15, with higher scores indicating greater impairment.
Change in Body Mass Index (BMI)
Time frame: Baseline to Week 12
Assessment of change in body mass index (BMI), calculated as body weight in kilograms divided by height in meters squared (kg/m²).
5 secondary outcomes
Change in HOMA-IR (Homeostatic Model Assessment for Insulin Resistance)
Time frame: Baseline to Week 12
Change in Waist Circumference
Time frame: Baseline to Week 12
Change in Blood Pressure
Time frame: Baseline to Week 12
Change in Global Acne Grading System (GAGS) Score
Time frame: Baseline to Week 12
Change in Polycystic Ovary Syndrome Quality of Life Questionnaire (PCOSQ)
Time frame: Baseline to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Berberine Phytosome (Sophy®) and Lifestyle Advice in people with Polycystic Ovary Syndrome, run by Liaquat University of Medical & Health Sciences at 1 site 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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Ferriman-Gallwey Score (Hirsutism) (time frame: Baseline to Week 12). The study lists 3 primary outcomes in all. 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 19 Mar 2026.