HypercholesterolemiaNCT07789366
Berberol P for Mild-to-Moderate Hypercholesterolaemia
A study testing Berberol® P (manufacturer: PharmExtracta S.p.A.) and Berberol® K (manufacturer: PharmExtracta S.p.A.) in people with Hypercholesterolemia, run by Liaquat University of Medical & Health Sciences at 4 sites in Italy.
Trial summary
This randomized, controlled, multicentre clinical trial will evaluate the efficacy and safety of Berberol® P compared with Berberol® K in adults with mild-to-moderate hypercholesterolaemia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Berberol® P (manufacturer: PharmExtracta S.p.A.) and Berberol® K (manufacturer: PharmExtracta S.p.A.)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 4 sitesItaly
- Study dates
- 7 Sep 2026to 30 Jul 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years
- Male or female
- LDL-C 115-190 mg/dL and/or total cholesterol 200-260 mg/dL
- Triglycerides <400 mg/dL
- Willingness to maintain stable diet and physical activity
- Written informed consent for study participation obtained prior to the start of the study
Who cannot join
- Use of statins, ezetimibe, fibrates, PCSK9 inhibitors, or lipid-lowering nutraceuticals within 30 days prior to enrollment
- Uncontrolled diabetes
- Significant liver or kidney disease
- Pregnancy or breastfeeding
- Known intolerance to any component of the study products
- Recent cardiovascular events
Show all 9Show fewer
- Alcohol or drug abuse
- Participation in another clinical trial within 30 days prior to enrollment
- Lack of written informed consent
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy4 sites
Euromed
Guidonia Montecelio, Lazio, 00012
Luciano Arcari, MD, lulalug4@gmail.com
Poliambulatorio Health
Piacenza, Emilia-Romagna, 29122
Giuliana Rapacioli, MD, giuly.rapacioli@gmail.com
Endomed
Rome, Lazio, 00152
Paolo Falasca, MD, p.falasca@yahoo.it
University of Urbino Carlo Bo
Urbino, The Marches, 61029
Giordano Zonzini, MD, giordanozonzini@gmail.com
About this study
Official title: A Randomized, Controlled, Multicentre, Three-Arm Clinical Trial to Evaluate the Efficacy and Safety of Berberol® P Compared With Berberol® K in Adults With Mild-to-Moderate Hypercholesterolaemia
This randomized, controlled, multicentre clinical trial will evaluate the efficacy and safety of Berberol® P compared with Berberol® K in adults with mild-to-moderate hypercholesterolaemia.
A total of 255 participants will be randomized in a 1:1:1 ratio to receive Berberol® P 1 tablet daily, Berberol® P 2 tablets daily, or Berberol® K 1 tablet daily for 12 weeks. The study will primarily assess whether Berberol® P is non-inferior to Berberol® K in reducing low-density lipoprotein cholesterol (LDL-C). Changes in other lipid parameters, glucose metabolism, anthropometric measures, blood pressure, and safety will also be evaluated.
Read the detailed description
Hypercholesterolaemia is an important modifiable cardiovascular risk factor. Nutraceutical approaches may provide an option for individuals with mild-to-moderate hypercholesterolaemia, particularly when lifestyle measures alone are insufficient.
This is a randomized, controlled, multicentre, three-arm clinical trial evaluating two daily doses of Berberol® P compared with Berberol® K. Eligible participants will be randomized in a 1:1:1 ratio to one of three treatment groups: Berberol® P 1 tablet daily, Berberol® P 2 tablets daily, or Berberol® K 1 tablet daily. Treatment will continue for 12 weeks.
The primary objective is to evaluate the non-inferiority of Berberol® P compared with Berberol® K with respect to the change in LDL-C after 12 weeks of treatment. The study will also evaluate effects on the lipid profile, glucose metabolism, anthropometric parameters and blood pressure, as well as the safety and tolerability of the interventions.
A total of 255 participants are planned to be enrolled across multiple study centres.
- Conditions
- Hypercholesterolemia
- Being tested
- Berberol® P (manufacturer: PharmExtracta S.p.A.), Berberol® K (manufacturer: PharmExtracta S.p.A.)
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Berberol® P (manufacturer: PharmExtracta S.p.A.)Dietary supplement
Dietary supplement containing Berberine Phytosome® and Pycrinil®. Participants receive either 1 tablet daily after dinner or 2 tablets daily (1 after breakfast and 1 after dinner) for 12 weeks, according to the assigned treatment arm.
Berberol® K (manufacturer: PharmExtracta S.p.A.)Dietary supplement
Dietary supplement containing Berberine Phytosome® and monacolins from fermented red yeast rice. Participants receive 1 tablet daily after dinner for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Berberol® P - 1 Tablet Daily | Experimental | Participants will receive Berberol® P 1 tablet once daily after dinner for 12 weeks. Receives: Dietary Supplement: Berberol® P (manufacturer: PharmExtracta S.p.A.) |
| Berberol P® - 2 Tablets Daily | Experimental | Participants will receive Berberol® P 2 tablets daily, with 1 tablet after breakfast and 1 tablet after dinner, for 12 weeks. Receives: Dietary Supplement: Berberol® P (manufacturer: PharmExtracta S.p.A.) |
| Berberol K® - 1 Tablet Daily | Active comparator | Participants will receive Berberol® K 1 tablet once daily after dinner for 12 weeks. Receives: Dietary Supplement: Berberol® K (manufacturer: PharmExtracta S.p.A.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline
Change in serum LDL-C concentration from baseline to the end of treatment. The primary analysis will assess the non-inferiority of Berberol® P compared with Berberol® K in reducing LDL-C.
Measured: Baseline to Week 12
Secondary outcomes (27)
Change in Total Cholesterol From Baseline
Change in serum total cholesterol concentration from baseline to the end of the 12-week treatment period.
Measured: Baseline to Week 12
Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline
Change in serum HDL-C concentration from baseline to the end of the 12-week treatment period.
Measured: Baseline to Week 12
Change in Triglycerides From Baseline
Change in serum triglyceride concentration from baseline to the end of the 12-week treatment period.
Measured: Baseline to Week 12
Change in Fasting Blood Glucose From Baseline
Change in fasting blood glucose concentration (mg/dL) from baseline to the end of treatment.
Measured: Baseline to Week 12
Change in Glycated Hemoglobin (HbA1c) From Baseline
Change in HbA1c (%) from baseline to the end of the 12-week treatment period.
Measured: Baseline to Week 12
Change in Fasting Insulin From Baseline
Change in fasting serum insulin concentration from baseline to the end of the 12-week treatment period.
Measured: Baseline to Week 12
Change in Systolic Blood Pressure From Baseline
Change in systolic blood pressure (mmHg) from baseline to the end of the 12-week treatment period.
Measured: Baseline to Week 12
Change in Diastolic Blood Pressure From Baseline
Change in diastolic blood pressure (mmHg) from baseline to the end of the 12-week treatment period.
Measured: Baseline to Week 12
Change in Heart Rate From Baseline
Change in heart rate (beats per minute) from baseline to the end of the 12-week treatment period.
Measured: Baseline to Week 12
Incidence of Adverse Events
Number and proportion of participants experiencing adverse events during the 12-week treatment period.
Measured: Baseline to Week 12
Change in Safety Laboratory Parameters From Baseline
Change from baseline to Week 12 in safety laboratory parameters, including aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatine phosphokinase (CPK), C-reactive protein (CRP), and creatinine.
Measured: Baseline to Week 12
Change in Body Weight From Baseline
Change in body weight (kg) from baseline to the end of the 12-week treatment period.
Measured: Baseline to Week 12
Change in Waist Circumference From Baseline
Change in waist circumference (cm) from baseline to the end of the 12-week treatment period.
Measured: Baseline to Week 12
Change in Non-HDL Cholesterol From Baseline
Change in calculated non-HDL cholesterol concentration from baseline to the end of the 12-week treatment period.
Measured: Baseline to Week 12
Change in Very-Low-Density Lipoprotein (VLDL) Cholesterol From Baseline
Change in calculated VLDL cholesterol concentration (mg/dL) from baseline to the end of the 12-week treatment period.
Measured: Baseline to Week 12
Change in Total Cholesterol to HDL Cholesterol Ratio (TC/HDL) From Baseline
Change in calculated total cholesterol to HDL cholesterol ratio (TC/HDL) from baseline to the end of the 12-week treatment period.
Measured: Baseline to Week 12
Change in LDL Cholesterol to HDL Cholesterol Ratio (LDL/HDL) From Baseline
Change in calculated LDL cholesterol to HDL cholesterol ratio (LDL/HDL) from baseline to the end of the 12-week treatment period.
Measured: Baseline to Week 12
Change in Triglyceride to HDL Cholesterol Ratio (TG/HDL) From Baseline
Change in calculated triglyceride to HDL cholesterol ratio (TG/HDL) from baseline to the end of the 12-week treatment period.
Measured: Baseline to Week 12
Change in Remnant Cholesterol From Baseline
Change in calculated remnant cholesterol concentration from baseline to the end of the 12-week treatment period.
Measured: Baseline to Week 12
Change in Apolipoprotein A1 (Apo A1) From Baseline
Change in Apo A1 concentration from baseline to the end of the 12-week treatment period.
Measured: Baseline to Week 12
Change in Apolipoprotein B (ApoB) From Baseline
Change in ApoB concentration (mg/dL) from baseline to the end of the 12-week treatment period.
Measured: Baseline to Week 12
Change in Apolipoprotein B to Apolipoprotein A1 Ratio (ApoB/Apo A1) From Baseline
Change in the calculated ApoB/Apo A1 ratio from baseline to the end of the 12-week treatment period.
Measured: Baseline to Week 12
Severity of Undesirable Symptoms
Severity of undesirable symptoms during treatment, including myalgias, cramps, nausea, diarrhea, constipation, abdominal pain, asthenia, and headache, assessed by participants on a 0 to 10 scale, where 0 indicates "no problem" and 10 indicates "very severe problem," based on symptoms experienced during the previous 7 days.
Measured: Baseline to Week 12
Frequency of Undesirable Symptoms
Frequency of undesirable symptoms, including myalgias, cramps, nausea, diarrhea, constipation, abdominal pain, asthenia, and headache. For each symptom present, participants will report its frequency as occasional, intermittent, or daily.
Measured: Baseline to Week 12
Participant-Reported Treatment Tolerability Score on a 0-10 Scale
Treatment tolerability will be assessed by participants at Week 12 using the protocol-defined 0-10 numerical rating scale and recorded in the case report form (CRF).
Measured: Week 12
Participant-Reported Treatment Adherence Percentage
Treatment adherence will be assessed at Week 12 using the protocol-defined 0-100% adherence scale recorded in the CRF.
Measured: Week 12
Treatment Adherence Based on Returned Unused Tablets
Treatment adherence will be assessed at Week 12 based on the number of unused study tablets returned by participants at the end of the treatment period.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start7 Sep 2026 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- None (open label)
- Enrolment
- 255 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
- Principal investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789366
- Sponsor's protocol ID
- 181_15luglio2026_BERBEROL_Sist
- Status last verified
- Aug 2026
- First submitted
- 22 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multicentre, Three-Arm Clinical Trial to Evaluate the Efficacy and Safety of Berberol® P Compared With Berberol® K in Adults With Mild-to-Moderate Hypercholesterolaemia
- ClinicalTrials.gov ID
- NCT07789366
- Acronym / sponsor ID
- 181_15luglio2026_BERBEROL_Sist
- Conditions
- Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Collaborators
- University of Urbino "Carlo Bo"
- Study start
- 7 Sep 2026 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 27 Aug 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 randomized, controlled, multicentre clinical trial will evaluate the efficacy and safety of Berberol® P compared with Berberol® K in adults with mild-to-moderate hypercholesterolaemia.
A total of 255 participants will be randomized in a 1:1:1 ratio to receive Berberol® P 1 tablet daily, Berberol® P 2 tablets daily, or Berberol® K 1 tablet daily for 12 weeks. The study will primarily assess whether Berberol® P is non-inferior to Berberol® K in reducing low-density lipoprotein cholesterol (LDL-C). Changes in other lipid parameters, glucose metabolism, anthropometric measures, blood pressure, and safety will also be evaluated.
Detailed description
Hypercholesterolaemia is an important modifiable cardiovascular risk factor. Nutraceutical approaches may provide an option for individuals with mild-to-moderate hypercholesterolaemia, particularly when lifestyle measures alone are insufficient.
This is a randomized, controlled, multicentre, three-arm clinical trial evaluating two daily doses of Berberol® P compared with Berberol® K. Eligible participants will be randomized in a 1:1:1 ratio to one of three treatment groups: Berberol® P 1 tablet daily, Berberol® P 2 tablets daily, or Berberol® K 1 tablet daily. Treatment will continue for 12 weeks.
The primary objective is to evaluate the non-inferiority of Berberol® P compared with Berberol® K with respect to the change in LDL-C after 12 weeks of treatment. The study will also evaluate effects on the lipid profile, glucose metabolism, anthropometric parameters and blood pressure, as well as the safety and tolerability of the interventions.
A total of 255 participants are planned to be enrolled across multiple study centres.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Berberol® P - 1 Tablet Daily | Experimental | Dietary Supplement: Berberol® P (manufacturer: PharmExtracta S.p.A.)Participants will receive Berberol® P 1 tablet once daily after dinner for 12 weeks. |
| Berberol P® - 2 Tablets Daily | Experimental | Dietary Supplement: Berberol® P (manufacturer: PharmExtracta S.p.A.)Participants will receive Berberol® P 2 tablets daily, with 1 tablet after breakfast and 1 tablet after dinner, for 12 weeks. |
| Berberol K® - 1 Tablet Daily | Active comparator | Dietary Supplement: Berberol® K (manufacturer: PharmExtracta S.p.A.)Participants will receive Berberol® K 1 tablet once daily after dinner for 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-70 years
- Male or female
- LDL-C 115-190 mg/dL and/or total cholesterol 200-260 mg/dL
- Triglycerides <400 mg/dL
- Willingness to maintain stable diet and physical activity
Key exclusion criteria (9 listed)
- Use of statins, ezetimibe, fibrates, PCSK9 inhibitors, or lipid-lowering nutraceuticals within 30 days prior to enrollment
- Uncontrolled diabetes
- Significant liver or kidney disease
- Pregnancy or breastfeeding
- Known intolerance to any component of the study products
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 |
|---|---|---|
| Berberol® P (manufacturer: PharmExtracta S.p.A.)Dietary supplement containing Berberine Phytosome® and Pycrinil®. Participants receive either 1 tablet daily after dinner or 2 tablets daily (1 after breakfast and 1 after dinner) for 12 weeks, according to the assigned treatment arm. | Dietary supplement | Berberol P® - 2 Tablets Daily, Berberol® P - 1 Tablet Daily |
| Berberol® K (manufacturer: PharmExtracta S.p.A.)Dietary supplement containing Berberine Phytosome® and monacolins from fermented red yeast rice. Participants receive 1 tablet daily after dinner for 12 weeks. | Dietary supplement | Berberol K® - 1 Tablet Daily |
Primary outcome
Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline
Time frame: Baseline to Week 12
Change in serum LDL-C concentration from baseline to the end of treatment. The primary analysis will assess the non-inferiority of Berberol® P compared with Berberol® K in reducing LDL-C.
27 secondary outcomes
Change in Total Cholesterol From Baseline
Time frame: Baseline to Week 12
Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline
Time frame: Baseline to Week 12
Change in Triglycerides From Baseline
Time frame: Baseline to Week 12
Change in Fasting Blood Glucose From Baseline
Time frame: Baseline to Week 12
Change in Glycated Hemoglobin (HbA1c) From Baseline
Time frame: Baseline to Week 12
Change in Fasting Insulin From Baseline
Time frame: Baseline to Week 12
Change in Systolic Blood Pressure From Baseline
Time frame: Baseline to Week 12
Change in Diastolic Blood Pressure From Baseline
Time frame: Baseline to Week 12
Change in Heart Rate From Baseline
Time frame: Baseline to Week 12
Incidence of Adverse Events
Time frame: Baseline to Week 12
Change in Safety Laboratory Parameters From Baseline
Time frame: Baseline to Week 12
Change in Body Weight From Baseline
Time frame: Baseline to Week 12
Change in Waist Circumference From Baseline
Time frame: Baseline to Week 12
Change in Non-HDL Cholesterol From Baseline
Time frame: Baseline to Week 12
Change in Very-Low-Density Lipoprotein (VLDL) Cholesterol From Baseline
Time frame: Baseline to Week 12
Change in Total Cholesterol to HDL Cholesterol Ratio (TC/HDL) From Baseline
Time frame: Baseline to Week 12
Change in LDL Cholesterol to HDL Cholesterol Ratio (LDL/HDL) From Baseline
Time frame: Baseline to Week 12
Change in Triglyceride to HDL Cholesterol Ratio (TG/HDL) From Baseline
Time frame: Baseline to Week 12
Change in Remnant Cholesterol From Baseline
Time frame: Baseline to Week 12
Change in Apolipoprotein A1 (Apo A1) From Baseline
Time frame: Baseline to Week 12
Change in Apolipoprotein B (ApoB) From Baseline
Time frame: Baseline to Week 12
Change in Apolipoprotein B to Apolipoprotein A1 Ratio (ApoB/Apo A1) From Baseline
Time frame: Baseline to Week 12
Severity of Undesirable Symptoms
Time frame: Baseline to Week 12
Frequency of Undesirable Symptoms
Time frame: Baseline to Week 12
Participant-Reported Treatment Tolerability Score on a 0-10 Scale
Time frame: Week 12
Participant-Reported Treatment Adherence Percentage
Time frame: Week 12
Treatment Adherence Based on Returned Unused Tablets
Time frame: 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 27 Aug 2026.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Berberol® P (manufacturer: PharmExtracta S.p.A.) and Berberol® K (manufacturer: PharmExtracta S.p.A.) in people with Hypercholesterolemia, run by Liaquat University of Medical & Health Sciences at 4 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 6 inclusion and 9 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 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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?
Contact Prof. Davide Sisti, PhD (+39 0722 303301, davide.sisti@uniurb.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (time frame: Baseline to Week 12). 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 27 Aug 2026.