ACTRN12605000232639
Completed
Phase 3
Dose Response Studyto determine the efficacy and safety of a Complementary Medicine Formulation, in tablet form, for lowering lipid levels in primary Hypercholesterolaemia by comparing baseline levels of lipids with post treatment lipid levels.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Pathways
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •LDL cholesterol 3\.5 and 5\.7mmol/L2\. Body mass index 32kg/m23\. Subject is willing to cease all medications over the course of the study, excluding medications for acute conditions such as pain or dyspepsia.
Exclusion Criteria
- •1\. Individuals with triglyceride levels \>4mmol/L2\. Individuals with a total cholesterol level \>10 mmol/L3\. Individuals with clinically abnormal liver function tests at baseline (measured at visit 2\). 4\. Women who are pregnant or unwilling to use birth control for the period of the study. 5\.Individuals with diabetes6\. Individuals with hyperthyroidism. 7\.Individuals with obstructive bile duct disease. 8\.Individuals with metabolic disorders other than primary hypercholesterolaemia, including phytosterolaemia. 9\.Individuals who smoke. 10\.Individuals with cardiovascular disease. 11\.Subjects unwilling to comply with the study protocols. 12\.Subjects with poor venous access. 13\.Any other condition which in the opinion of the researchers could compromise the study.
Outcomes
Primary Outcomes
Not specified
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