CompletedPhase 3ACTRN12605000288628

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

Sponsor

Sylvan Australia Pty Ltd

Enrollment

72 participants

Start Date

Apr 7, 2005

Study Type

Interventional

Conditions

Hypercholesterolemia

Summary

This stage is a randomised, double blind, placebo-controlled, three arm parallel study. The study will compare baseline lipid levels with post-treatment levels for the treatment and placebo groups over a 12-week period. Interim analyses of the data will be conducted at the completion of stage 1, and subjects will be issued with the active medication at the end of week 12. The analysis of data will continue for 8 weeks. Stage 2 continued as an open label trial for 40 weeks and stage 3 continued as an open label trial for a further 48 weeks.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Inclusion Criteria1

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

Exclusion Criteria1

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.

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Interventions

The active treatment was 2.4g Red Yeast Rice taken orally. The placebo was made up of the same excipient base as the active treatment and was indistinguishable in size, shape and taste to the active

The active treatment was 2.4g Red Yeast Rice taken orally. The placebo was made up of the same excipient base as the active treatment and was indistinguishable in size, shape and taste to the active treatment and was taken orally. Stage 1 (12 weeks)was a three arm study as follows: Arm 1: participants taking 2 active capsules with a meal in the morning and 2 active capsules with a meal at night. Arm 2: participants taking 2 placebo capsules with a meal in the morning and 2 active capsules with a meal at night Arm 3: participants taking 2 placebo capsules with a meal in the morning and 2 placebo capsules with a meal at night. Stage 2: Particpants subsequently took 2 active tablets in the morning and two active tablets at night for 40 weeks. Stage3: Participants took 2 active capsules at night and 2 active capsules in the morning for 48 weeks.