Study on the safety and efficacy of sylvan Red Yeast Rice in adults with primary hypercholesteremia

Completed

• Conditions: Hypercholesteremia; Nutritional, Metabolic, Endocrine; Hypercholesterolemia

• Registration Number: ISRCTN74551315
• Lead Sponsor: Sylvan Health Pty Ltd (Australia)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-21
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. LDL cholesterol more than or equal to 3.5 to less than or equal to 5.7 mmol/l
2. Aged 18 to 75 years
3. Body mass index less than or equal to 32 kg/m^2

Exclusion Criteria

1. Triglyceride levels more than 4 mmol/l
2. Total cholesterol more than 10 mmol/l
3. Use of lipid lowering medications including herbal and other natural lipid lowering agents within one month of baseline
4. Liver function enzymes more than three times the upper limit of normal at baseline
5. Pregnant women or women unwilling to use birth control for the duration of the study
6. Diabetes
7. Hypothyroidism
8. Smoking
9. Cardiovascular disease
10. Subjects unwilling to comply with study protocol
11. Poor venous access
12. Any other condition, which in the opinion of the investigators could compromise the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in LDL cholesterol from baseline to end of treatment.

Secondary Outcome Measures

Name	Time	Method
Change in total cholesterol, High-Density Lipoprotein cholesterol (HDL) and triglycerides.