Study on the Safety and Efficacy of Sylvan Red Yeast Rice in Adults with Primary Hypercholesterolemia

Phase 3

Completed

• Conditions: Hypercholesterolemia; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12605000288628
• Lead Sponsor: Sylvan Australia Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

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

Inclusion Criteria

LDL cholesterol 3.5 - 5.7 mmol/L. Body mass index 32kg/m2.

Exclusion Criteria

Triglyceride levels > 4 mmol/L. Total cholesterol > 10 mmol/L. Use of lipid lowering medications including herbal and other natural lipid lowering agents within one month of baseline. Liver function enzymes >3 times the upper limit of normal at baseline. Pregnant women or women unwilling to use birth control for the duration of the study.Diabetes. Hypothyroidism. Smoking. Cardiovascular disease. Subjects unwilling to comply with study protocol. Poor venous access. 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.[At baseline and at end of treatment]

Secondary Outcome Measures

Name	Time	Method
Change in total cholesterol[Baseline, week 4, week 8, week 12 and every 8 weeks till end of treatment.];Change in total high-density lipoprotein cholesterol (HDL)[Baseline, week 4, week 8, week 12 and every 8 weeks till end of treatment.];Change in total triglycerides.[Baseline, week 4, week 8, week 12 and every 8 weeks till end of treatment.]