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

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

Clinical Phase

NA

Total Enrollment

221 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-19

Study Completion Date

2023-07-31

Brief Summary

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Nutraceutical lipid-lowering interventions are becoming increasingly popular, particularly among patients who are intolerant or refractory to prescription statins, or who desire alternative non-conventional pharmacological treatment to manage their dyslipidaemia, whether they previously experienced statin intolerance or not. A growing body of preclinical and clinical evidence suggest that the amla (Emblica officinalis) red yeast rice (RYR), olive and walnut leaf extracts posses consideable hpolipidaemic pharmacological effects.

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Detailed Description

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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®) on total cholesterol (TC), low-density lipoprotein - cholesterol (LDL-C), high-density lipoprotein - cholesterol (HDL-C), non-high-density lipoprotein - cholesterol (non-HDL-C), remnant cholesterol (RC) and triglycerides (TG) in hyperlipidaemic patients.

Conditions

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Hyperlipidemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Cholesfytol NG®) supplement treatment

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cholesfytol NG®) supplement

Patients will receive a single oral dose of 2 tablets a day of Cholesfytol NG®) supplement for 2-months.

Group Type EXPERIMENTAL

Cholesfytol NG®) supplement

Intervention Type DIETARY_SUPPLEMENT

General Practitioner (GP) prescribed oral Cholesfytol NG®) supplement

Interventions

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Cholesfytol NG®) supplement

General Practitioner (GP) prescribed oral Cholesfytol NG®) supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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