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Clinical Trials in Italy / NCT07789366
Starting soon Not applicable

Berberol P for Mild-to-Moderate Hypercholesterolaemia

NCT07789366 · tracked via the Priya Life Science Italy tracker
Sponsor
Liaquat University of Medical & Health Sciences
Phase
Not applicable
Started
2026-09-07
Last updated
2026-08-27

Condition(s) studied

Hypercholesterolemia

Investigational drug(s) / intervention(s)

Berberol® P (manufacturer: PharmExtracta S.p.A.)Berberol® K (manufacturer: PharmExtracta S.p.A.)

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.

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.

Study 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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Alcohol or drug abuse * Participation in another clinical trial within 30 days prior to enrollment * Lack of written informed consent

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Poliambulatorio Health Piacenza Emilia-Romagna
Euromed Guidonia Montecelio Lazio
Endomed Rome Lazio
University of Urbino Carlo Bo Urbino The Marches

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Other trials for the same condition

Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Bempedoic Acid in Italy Recruiting
Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia Active, not recruiting
Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy Recruiting
Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy Recruiting
Effect of Two Food Supplements on Lipid Profile in Patients With Mild Hypercholesterolemia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07789366 on ClinicalTrials.gov ↗ ← All trials in Italy