Healthy Clinical Trial
Official title:
Antioxidant Effect of Treatment With Ginkgo Biloba L. Leaf Extract (IDN 5933) on DNA Cell Maintenance and Genomic Stability: A Randomised Study Versus Placebo
Primary objective: The primary objective of this study is to assess the effect of Ginkgo
biloba L. leaf extract (IDN 5933) in comparison to placebo in human subjects treated at
therapeutic doses for 6 months on the level of DNA damage and genomic instability, measured
with the Comet Assay and the Micronucleus assay, respectively .
Secondary objective:
The secondary objective of this study is to provide a preliminary assessment of the safety of
Ginkgo biloba L. leaf extract (IDN 5933) in human subjects treated at therapeutic doses in
term of adverse drug reaction, hepatotoxicity, genotoxicity.
The study will be a randomised clinical trial comparing subjects receiving twice-daily doses
of either 120-mg of Ginkgo biloba L. leaf extract (IDN 5933) or placebo for a 6 months
period.
Primary Endpoints:
- DNA Damage assessed with the Comet assay as proportion of DNA in the tail.
- Micronucleus frequency (MN) in peripheral blood lymphocytes (Frequency per 1000
binucleated cells).
Secondary Endpoints:
- Complete clinical assessment at the beginning and at the end of the study.
- Occurrence of Adverse drug reactions in individuals treated with GBE or placebo.
- Liver functions will be monitored according to biological laboratory examinations and
clinical symptoms. A subgroup of individuals will be monitored also for genetic
parameters concerning expression patterns of genes putatively associated to early events
of HCC carcinogenesis Clinical and biological parameters will be measured in the study
groups at the beginning (T0) and at the end of the study (T2).
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