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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000232639

Enrollment

Registered

2005-08-26

Start date

2002-10-09

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Outcome results