The effect of micro encapsulated highly bioavailable Simvastatin on plasma lipid profile and oxidative status in patients with high plasma cholesterol level

Phase 2

Recruiting

• Conditions: atherosclerosis; hyperlipidemia; hypercholesterolemia; cardiovascular disease; coronary heart disease; Metabolic and Endocrine - Metabolic disorders; Cardiovascular - Coronary heart disease; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12615000357550
• Lead Sponsor: ycotec Ltd, Cambridge, UK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Major inclusion criteria were as follows: Caucasian male or female subjects 40-65 years old, elevated total plasma cholesterol (over 200 mg/dl), elevated plasma LDL (over 150 mg/dl), plasma markers for oxidative stress LDL-Px ELISA ×103 over 250 microM/ml and IOD over 40 microM/mL, absence of concomitant intake of anti-hypertensive, lipid-lowering or any other cardiovascular drugs.

Exclusion Criteria

Among exclusion criteria were:
(1)Unwillingness to sign informed consent.
(2) Unable to comply with the protocol for the duration
of the study.
(3) History of MI in the 3 months preceding the study.
(4) Ejection fraction (EF) higher than 45%.
(5) Significant medical condition that would impact
safety considerations (e.g., significantly elevated LFT,
hepatitis, severe dermatitis, uncontrolled diabetes,
cancer, severe GI disease, fibromyalgia, renal failure,
recent CVA (cerebrovascular accident), pancreatitis,
respiratory diseases, epilepsy, etc.).
(6) Compulsive alcohol abuse (more than 10 drinks weekly), or
regular exposure to other substances of abuse.
(7) Participation in other nutritional or pharmaceutical
studies.
(8) Resting heart rate of more than 100 beats per minute or less than 45 beats per minute. inability to comply with the study protocol, severe medical conditions (hepatitis, pancreatitis, uncontrolled diabetes, cancer, recent cardiovascular events, tuberculosis etc).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome of this clinical trial is to verify an effect of lycosome formulated simvastatin (Lycosimvastatin)on blood lipid profile in patients with hypercholesterolemia as assessed by biochemical measurements of major classes of lipids in serum and plasma using Biosystems Inc. microanalyzer with corresponding analytic kits. <br><br>and oxidative status in patients with hypercholesterolemia. [End of the 4th week of interventional period];Primary outcome of this clinical trial is to verify an effect of lycosome formulated simvastatin (Lycosimvastatin)on parameters of oxidation in the patients with hypercholesterolemia as assessed by biochemical measurements of malonic dialdehyde levels and activity of superoxide dismutase in blood.[End of the 4th week of interventional period]

Secondary Outcome Measures

Name	Time	Method
-Investigation of the effect of Lycosimvastatin on composition of plasma lipid profile (total cholesterol, LDL, HDL, triglycerides) in patients with hypercholesterolemia as assessed by biochemical measurements of major lipid classes in plasma.<br>[End of the 2nd and 4th week of interventional period];Evaluation of the effect of Lycosimvastatin on oxidative status in patients with hypercholesterolemia as assessed by biochemical measurements of malonic dialdehyde and acitivity of superoxide dismutase in plasma.[End of the 2nd and 4th weeks of interventional period]