A Follow-up Study of the Efficacy of a Complementary Medicine Formulation in Primary Hypercholesterolemia
- Conditions
- Primary hypercholesteremiaDiet and Nutrition - Other diet and nutrition disorders
- Registration Number
- ACTRN12605000257662
- Lead Sponsor
- Pathways
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
1. LDL cholesterol ³3.5 and 5.7mmol/L 2. 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.
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 study5. Individuals with diabetes6. Individuals with hyperthyroidism7. Individuals with obstructive bile duct disease8. Individuals with metabolic disorders other than primary hypercholesterolaemia, includingphytosterolaemia9. Individuals who smoke10. Individuals with cardiovascular disease11. Subjects unwilling to comply with the study protocols12. Subjects with poor venous access13. Any other condition which in the opinion of the researchers could compromise the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in fasting serum low-density lipoprotein (LDL) cholesterol level from baseline to end of treatment.[]
- Secondary Outcome Measures
Name Time Method Changes in fasting serum levels of total cholesterol[];Changes in high-density lipoprotein cholesterol (HDL)[];Changes in triglycerides[];Changes in apolipoproteins B and A-1[];Changes in coenzyme Q10 and homocysteine.[]