MedTrace Logo

Berberol P for Mild-to-Moderate Hypercholesterolaemia

NCT07789366 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2026-08-27

No results posted yet for this 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.

Conditions

Interventions

DIETARY_SUPPLEMENT

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® 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.

Sponsors & Collaborators

  • University of Urbino "Carlo Bo"

    collaborator OTHER

  • Liaquat University of Medical & Health Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-07
Primary Completion
2027-07-30
Completion
2027-07-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07789366 on ClinicalTrials.gov