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Effects of Armolipid Plus on Cholesterol Levels and Endothelial Function

NCT ID: NCT00654459

Last Updated: 2008-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-04-30

Brief Summary

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Some nutraceuticals are often advised for their lipid lowering effects. Although many clinical trials have been conducted to assess their efficacy many doubts remain whether they could be considered an effective alternative to statins therapy.

The aim of this study was to evaluate the lipid lowering effects and the improvement of endothelial dysfunction in patients with hyperlipidemia, treated with a nutraceutical product (Armolipid Plus)

Detailed Description

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Conditions

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Hyperlipidemia Endothelial Dysfunction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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A

Mixture of Berberine, Policosanol, Red Yeast, Placebo

Intervention Type DIETARY_SUPPLEMENT

A tablet one a day for 6 weeks

B

Mixture of Berberine, Policosanol, Red Yeast, Placebo

Intervention Type DIETARY_SUPPLEMENT

A tablet one a day for 6 weeks

Interventions

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Mixture of Berberine, Policosanol, Red Yeast, Placebo

A tablet one a day for 6 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Armolipid Plus

Eligibility Criteria

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Inclusion Criteria

* Males and females aged between 18 and 70
* Total cholesterol levels \> 220 mg/dl and LDL-Cholesterol \> 130 mg/dl;
* Patients with concomitant pathology such as diabetes, chronic heart failure, coronary artery disease, arterial hypertension, dysthyroidism, were admitted as long as stable in the previous three months

Exclusion Criteria

* Proven intolerance to an Armolipid Plus compound
* Pregnant women, and women planning to conceive
* Patients in therapy with lipid lowering drugs within the previous 6 weeks
* Triglycerides concentration \> 500mg/dl were excluded.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rottapharm

INDUSTRY

Sponsor Role collaborator

Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Federico II University

Principal Investigators

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Serafino Fazio, MD

Role: PRINCIPAL_INVESTIGATOR

Federico II University

Locations

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Department of internal medicine University Federico II

Naples, , Italy

Site Status

Countries

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Italy

Other Identifiers

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ARM 02-07

Identifier Type: -

Identifier Source: org_study_id