A Follow-up Study of the Efficacy of a Complementary Medicine Formulation in Primary Hypercholesterolemia

A Follow-up Study to determine the efficacy and safety profile of a Pathway formulation in lowering lipid levels in primary hypercholesteremia over a 24-week period. of a Complementary Medicine Formulation in Primary Hypercholesterolemia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000257662

Enrollment

Registered

2005-09-01

Start date

2003-09-09

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

A follow-up study to determine the efficacy and safety profile of a natural medicine formulation in lowering lipid levels in primary hypercholesteremia over a 6-month period. The study also looked at the effect of the preparation on coenzyme Q10 levels.Study blood parameters were measured every 4 weeks

Interventions

A novel combination of plant extracts and vitamins which was delivered over 24 weeks.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

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.

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 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.

Outcome results