An interventional study of Berberol® P (manufacturer: PharmExtracta S.p.A.) and Berberol® K (manufacturer: PharmExtracta S.p.A.) in Hypercholesterolemia, sponsored by Liaquat University of Medical & Health Sciences. Not yet recruiting at 4 sites in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Liaquat University of Medical & Health Sciences · Not applicable, Interventional, and Treatment
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.
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.
1,175 studies on the registry are indexed under Hypercholesterolemia; 93 are open to participants now.
This study's planned enrollment of 255 is above the median of 110 across 975 interventional studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →Liaquat University of Medical & Health Sciences is the lead sponsor of 55 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive Berberol® P 1 tablet once daily after dinner for 12 weeks.
Dietary Supplement: Berberol® P (manufacturer: PharmExtracta S.p.A.)
Participants will receive Berberol® P 2 tablets daily, with 1 tablet after breakfast and 1 tablet after dinner, for 12 weeks.
Dietary Supplement: Berberol® P (manufacturer: PharmExtracta S.p.A.)
Participants will receive Berberol® K 1 tablet once daily after dinner for 12 weeks.
Dietary Supplement: Berberol® K (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 containing Berberine Phytosome® and monacolins from fermented red yeast rice. Participants receive 1 tablet daily after dinner for 12 weeks.
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
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
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
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
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
Change in Glycated Hemoglobin (HbA1c) From Baseline
Change in HbA1c (%) from baseline to the end of the 12-week treatment period.
Time frame: Baseline to Week 12
Change in Fasting Insulin From Baseline
Change in fasting serum insulin concentration from baseline to the end of the 12-week treatment period.
Time frame: Baseline to Week 12
Change in Systolic Blood Pressure From Baseline
Change in systolic blood pressure (mmHg) from baseline to the end of the 12-week treatment period.
Time frame: Baseline to Week 12
Change in Diastolic Blood Pressure From Baseline
Change in diastolic blood pressure (mmHg) from baseline to the end of the 12-week treatment period.
Time frame: Baseline to Week 12
Change in Heart Rate From Baseline
Change in heart rate (beats per minute) from baseline to the end of the 12-week treatment period.
Time frame: Baseline to Week 12
Incidence of Adverse Events
Number and proportion of participants experiencing adverse events during the 12-week treatment period.
Time frame: Baseline to Week 12
Change in Safety Laboratory Parameters From Baseline
Change from baseline to Week 12 in safety laboratory parameters, including aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatine phosphokinase (CPK), C-reactive protein (CRP), and creatinine.
Time frame: Baseline to Week 12
Change in Body Weight From Baseline
Change in body weight (kg) from baseline to the end of the 12-week treatment period.
Time frame: Baseline to Week 12
Change in Waist Circumference From Baseline
Change in waist circumference (cm) from baseline to the end of the 12-week treatment period.
Time frame: Baseline to Week 12
Change in Non-HDL Cholesterol From Baseline
Change in calculated non-HDL cholesterol concentration from baseline to the end of the 12-week treatment period.
Time frame: Baseline to Week 12
Change in Very-Low-Density Lipoprotein (VLDL) Cholesterol From Baseline
Change in calculated VLDL cholesterol concentration (mg/dL) from baseline to the end of the 12-week treatment period.
Time frame: Baseline to Week 12
Change in Total Cholesterol to HDL Cholesterol Ratio (TC/HDL) From Baseline
Change in calculated total cholesterol to HDL cholesterol ratio (TC/HDL) from baseline to the end of the 12-week treatment period.
Time frame: Baseline to Week 12
Change in LDL Cholesterol to HDL Cholesterol Ratio (LDL/HDL) From Baseline
Change in calculated LDL cholesterol to HDL cholesterol ratio (LDL/HDL) from baseline to the end of the 12-week treatment period.
Time frame: Baseline to Week 12
Change in Triglyceride to HDL Cholesterol Ratio (TG/HDL) From Baseline
Change in calculated triglyceride to HDL cholesterol ratio (TG/HDL) from baseline to the end of the 12-week treatment period.
Time frame: Baseline to Week 12
Change in Remnant Cholesterol From Baseline
Change in calculated remnant cholesterol concentration from baseline to the end of the 12-week treatment period.
Time frame: Baseline to Week 12
Change in Apolipoprotein A1 (Apo A1) From Baseline
Change in Apo A1 concentration from baseline to the end of the 12-week treatment period.
Time frame: Baseline to Week 12
Change in Apolipoprotein B (ApoB) From Baseline
Change in ApoB concentration (mg/dL) from baseline to the end of the 12-week treatment period.
Time frame: Baseline to Week 12
Change in Apolipoprotein B to Apolipoprotein A1 Ratio (ApoB/Apo A1) From Baseline
Change in the calculated ApoB/Apo A1 ratio from baseline to the end of the 12-week treatment period.
Time frame: Baseline to Week 12
Severity of Undesirable Symptoms
Severity of undesirable symptoms during treatment, including myalgias, cramps, nausea, diarrhea, constipation, abdominal pain, asthenia, and headache, assessed by participants on a 0 to 10 scale, where 0 indicates "no problem" and 10 indicates "very severe problem," based on symptoms experienced during the previous 7 days.
Time frame: Baseline to Week 12
Frequency of Undesirable Symptoms
Frequency of undesirable symptoms, including myalgias, cramps, nausea, diarrhea, constipation, abdominal pain, asthenia, and headache. For each symptom present, participants will report its frequency as occasional, intermittent, or daily.
Time frame: Baseline to Week 12
Participant-Reported Treatment Tolerability Score on a 0-10 Scale
Treatment tolerability will be assessed by participants at Week 12 using the protocol-defined 0-10 numerical rating scale and recorded in the case report form (CRF).
Time frame: Week 12
Participant-Reported Treatment Adherence Percentage
Treatment adherence will be assessed at Week 12 using the protocol-defined 0-100% adherence scale recorded in the CRF.
Time frame: Week 12
Treatment Adherence Based on Returned Unused Tablets
Treatment adherence will be assessed at Week 12 based on the number of unused study tablets returned by participants at the end of the treatment period.
Time frame: Week 12
Start is estimated for Sep 2026; primary completion for Jul 2027, 10 months later.
Of 133 non-industry interventional studies with no phase under Hypercholesterolemia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 10 months is below that.
Counting every sponsor, half of 151 studies reached it within 15 months; a quarter within 6 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Liaquat University of Medical & Health Sciences