Health TrialsbyHealthPanel

Berberol P for Mild-to-Moderate Hypercholesterolaemia

ConditionHypercholesterolemia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorLiaquat University of Medical & Health Sciences

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

255 Participants
are divided into 3 treatment groups
Group A: Berberol® P - 1 Tablet DailyExperimental treatment 1 intervention
Group B: Berberol P® - 2 Tablets DailyExperimental treatment 1 intervention
Group C: Berberol K® - 1 Tablet DailyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline to Week 12

Secondary outcomes

1

Change in Total Cholesterol From Baseline

Change in serum total cholesterol concentration from baseline to the end of the 12-week treatment period.

Time frame
Baseline to Week 12
2

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.

Time frame
Baseline to Week 12
3

Change in Triglycerides From Baseline

Change in serum triglyceride concentration from baseline to the end of the 12-week treatment period.

Time frame
Baseline to Week 12
4

Change in Fasting Blood Glucose From Baseline

Change in fasting blood glucose concentration (mg/dL) from baseline to the end of treatment.

Time frame
Baseline to Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Liaquat University of Medical & Health Sciences

Lead sponsor

University of Urbino "Carlo Bo"

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: