Dose Response Study of a Complementary Medicine Formulation in Primary Hypercholesterolaemia
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.
Pathways
40 participants
Oct 9, 2002
Interventional
Conditions
Summary
This study is a two arm open comparison of two different dosage regimes undertaken in a homogeneous population comparing baseline measurements with effects of treatment.
Eligibility
Inclusion Criteria1
- 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 Criteria1
- 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.
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Interventions
Cynara scolymus: One arm took one tablet of the study medication twice a day (morning and evening with meals) and the other arm took two tablets twice a day (morning and evening with meals).
Locations(1)
View Full Details on ANZCTR
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ACTRN12605000232639