NCT07789366Not yet recruiting
Berberol P for Mild-to-Moderate Hypercholesterolaemia
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
Source: ClinicalTrials.gov · Last updated 27 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 255 (estimated)
- First submitted
- 22 Aug 2026
- Start date
- 7 Sept 2026
- Primary completion date
- 30 Jul 2027
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT07789366
What you commit to
- Study type: Interventional
- Planned participants: 255
- From 7 Sept 2026 to the primary completion date, 30 Jul 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of statins, ezetimibe, fibrates, PCSK9 inhibitors, or lipid-lowering nutraceuticals within 30 days prior to enrollment
- Alcohol or drug abuse
- Participation in another clinical trial within 30 days prior to enrollment
Other illness
- Uncontrolled diabetes
- Significant liver or kidney disease
Other
- Pregnancy or breastfeeding
- Known intolerance to any component of the study products
- Recent cardiovascular events
- Lack of written informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Euromed Coordinator of this site? Confirm its status | Guidonia Montecelio | Italy | Unknown status |
| Poliambulatorio Health Coordinator of this site? Confirm its status | Piacenza | Italy | Unknown status |
| Endomed Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| University of Urbino Carlo Bo Coordinator of this site? Confirm its status | Urbino | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.