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Berberol P for Mild-to-Moderate Hypercholesterolaemia
Sponsor: Liaquat University of Medical & Health Sciences
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.
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
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
255
Start Date
2026-09-07
Completion Date
2027-07-30
Last Updated
2026-08-27
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (4)
Poliambulatorio Health
Piacenza, Emilia-Romagna, Italy
Euromed
Guidonia Montecelio, Lazio, Italy
Endomed
Rome, Lazio, Italy
University of Urbino Carlo Bo
Urbino, The Marches, Italy