Hypercholesterolemia Clinical Trial
Official title:
A Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Study of Phyllanthus Emblica L. Fruit Extract (AMX160) in Patients With Hypercholesterolemia
This study evaluates the efficacy of a fresh fruit extract of Indian Gooseberry (AMX160) for the attenuation of increased blood cholesterol, LDL cholesterol and triglycerides in patients with hypercholesterolemia.
Phyllanthus emblica L. fruit (Emblica officinalis) has potent antioxidant properties. Animal
studies indicate that flavanoids from E. officinalis effectively reduced lipid levels in
serum and tissues and had a significant inhibitory effect on hepatic
hydroxymethylglutaryl-coenzyme A reductase activity.
The primary aim of this study is to determine whether Phyllanthus emblica L. fruit extract
AMX160 is an effective treatment for hypercholesterolemia patients as compared to placebo.
The investigators hypothesize that Phyllanthus emblica L. fruit extract AMX160 will
significantly lower the total cholesterol as compared to placebo in patients with
Hypercholesterolemia. A total of 132 patients including males and females with
hypercholesterolemia will be assigned at random to one of the two investigational products.
The study is expected to have a treatment duration of 90 ± 10 days and a total duration of
118 days including 14 days of grace period and 14 days of screening period per patient.
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