Dose Response Study of a Complementary Medicine Formulation in Primary Hypercholesterolaemia

Phase 3

Completed

• Conditions: Primary Hypercholesterolaemia; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12605000232639
• Lead Sponsor: Pathways

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified