Status:

COMPLETED

The Antihypercholestrolemic Effect of a Combined Nutritional Supplementation of Standardized Extracts of Amla, Walnut, Red Yeast Rice and Olive

Lead Sponsor:

Liaquat University of Medical & Health Sciences

Collaborating Sponsors:

KU Leuven

Conditions:

Hyperlipidemia

Eligibility:

All Genders

21+ years

Phase:

NA

Brief Summary

Nutraceutical lipid-lowering interventions are becoming increasingly popular, particularly among patients who are intolerant or refractory to prescription statins, or who desire alternative non-conven...

Detailed Description

The present exploratory study aimed to assess the safety, efficacy, and patient's satisfaction of a combined supplementation of amla, red yeast rice, olive, and walnut leaf extracts (Cholesfytol NG®) ...

Eligibility Criteria

Inclusion

  • Age ≥ 21 years
  • Both male or female
  • Blood total cholesterol (TC) level ≥ 200 mg/dL
  • Blood low-density lipoprotein cholesterol (LDL-C) level ≥ 130 mg/dL
  • With or without myalgia and/or diabetes
  • No prior treatment of cholesterol-lowering agents and/or patients whose cholesterol- lowering treatment did not allow them to reach LDL-C target
  • Patients who had stopped their cholesterol-lowering treatment because of side effects including myalgia

Exclusion

  • Pregnant nor breastfeeding patients

Key Trial Info

Start Date :

March 19 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 31 2023

Estimated Enrollment :

221 Patients enrolled

Trial Details

Trial ID

NCT06002893

Start Date

March 19 2020

End Date

July 31 2023

Last Update

August 21 2023

Active Locations (1)

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Cliniques universitaires St-Luc and Institut de Recherche Expérimentale et Clinique (IREC), KU Leuven

Leuven, Belgium