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Efficacy and Tolerability of the Nutraceutical Formulation Coleosoma in Dyslipidemic Subjects

NCT03027336 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2017-01-23

No results posted yet for this study

Summary

The overall objective of the study is to assess the efficacy of Coleosoma formulation (fermented red rice, berberine and chitosan) in reducing non-HDL cholesterol in dyslipidemic patients.

Conditions

  • Dyslipidemias

Interventions

DIETARY_SUPPLEMENT

Coleosoma

patients will take one tablet of 500mg daily for 12 weeks. No dose titration is foreseen.

DIETARY_SUPPLEMENT

Placebo

patients will take one tablet daily for 12 weeks.

Sponsors & Collaborators

  • DOC generici srl

    collaborator UNKNOWN

  • Azienda Ospedaliero-Universitaria di Parma

    lead OTHER

Principal Investigators

  • Alessandra Dei Cas, MD · University of Parma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-08-31
Completion
2016-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03027336 on ClinicalTrials.gov