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

L

Liaquat University of Medical & Health Sciences

Status

Completed

Conditions

Hyperlipidemia

Treatments

Dietary Supplement: Cholesfytol NG®) supplement

Study type

Interventional

Funder types

Other

Identifiers

NCT06002893
AK/08.08.2023/01

Details and patient eligibility

About

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.

Full 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®) 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.

Enrollment

221 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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

Exclusion criteria

  • Pregnant nor breastfeeding patients

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

221 participants in 1 patient group

Cholesfytol NG®) supplement
Experimental group
Description:
Patients will receive a single oral dose of 2 tablets a day of Cholesfytol NG®) supplement for 2-months.
Treatment:
Dietary Supplement: Cholesfytol NG®) supplement

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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