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Can a berberine supplement match red yeast rice for cholesterol?

NCT ID NCT07789366

Disease control Sponsor: Liaquat University of Medical & Health Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial tests two dietary supplements, Berberol P and Berberol K, in adults with mild-to-moderate high cholesterol. The goal is to see if Berberol P lowers LDL cholesterol as effectively as Berberol K. About 255 participants will take one of the supplements daily for 12 weeks. Researchers will also check changes in other blood fats, blood sugar, weight, and blood pressure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Berberol P (berberine phytosome and Pycrinil) and Berberol K (berberine phytosome and monacolins from red yeast rice), both dietary supplements
What this could lead to
If Berberol P works as well as Berberol K, people with mild-to-moderate high cholesterol might have another supplement option to help lower LDL cholesterol.
What could go wrong
This is a 12-week trial, so it cannot show long-term effects. The supplements may not lower cholesterol enough to matter, and results may not apply to everyone with high cholesterol.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 255 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Hypercholesterolemia hyperlipidemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypercholesterolemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Endomed

    Rome, Lazio, 00152, Italy

  • Euromed

    Guidonia Montecelio, Lazio, 00012, Italy

  • Poliambulatorio Health

    Piacenza, Emilia-Romagna, 29122, Italy

  • University of Urbino Carlo Bo

    Urbino, The Marches, 61029, Italy

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