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ClinicalTrials.gov ID

NCT07789366

Lead Sponsor

Liaquat University of Medical & Health SciencesOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

255Estimated

Last Update Posted

Aug 27, 2026Actual

Start Date

Sep 7, 2026Estimated

Primary Completion Date

Jul 30, 2027Estimated

Completion Date

Jul 30, 2027Estimated

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

Brief 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.

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.

• Hypercholesterolemia

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

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Liaquat University of Medical & Health SciencesOTHER

Collaborators

University of Urbino "Carlo Bo"OTHER

lulalug4@gmail.com

p.falasca@yahoo.it