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

Study Overview
=================
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-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.

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®) 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.

Official Title
-----------------
The Antihypercholestrolemic Pharmacological Effect of a Combined Supplement of Amla Fruit, Walnut Leaves, Red Yeast Rice, and Olive Fruit Extracts Leads to Improvement in Circulatory Levels of LDL-C and Remnant Cholesterol

Conditions
-----------------
Hyperlipidemia

Intervention / Treatment
-----------------
* Dietary Supplement: Cholesfytol NG®) supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Cholesfytol NG®) supplement treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cholesfytol NG®) supplement<br>Patients will receive a single oral dose of 2 tablets a day of Cholesfytol NG®) supplement for 2-months. | Dietary Supplement: Cholesfytol NG®) supplement<br>* General Practitioner (GP) prescribed oral Cholesfytol NG®) supplement<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood lipid profile | Decrease in blood total cholesterol (TC) concentration | 2-months | 
| Change in blood lipid profile | Decrease in blood low-density lipoprotein - cholesterol (LDL-C) concentration | 2-months | 
| Change in blood lipid profile | Decrease in blood triglycerides (TG) concentration | 2-months | 
| Change in blood lipid profile | Decrease in blood non-high density lipoprotein - cholesterol (non-HDL-C) concentration | 2-months | 
| Decrease in blood lipid profile | Change in blood remnant cholesterol (RC) concentration | 2-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of side effects | Number of patients reporting myalgia | 2-months |