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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
120mg/day, twice a day, 6 month
120mg/day, twice a day, 6 month
IRCCS San Raffaele Pisana
Rome, Italy
DNA Damage
DNA Damage assessed with the Comet assay as proportion of DNA in the tail
Time frame: through study completion, an average of 1 year
Micronucleus frequency
Micronucleus frequency (MN) in peripheral blood lymphocytes (Frequency per 1000 binucleated cells)
Time frame: through study completion, an average of 1 year
Clinical assessment
Complete clinical assessment at the beginning and at the end of the study by physiological parameters
Time frame: through study completion, an average of 1 year
Liver functions
Liver functions will be monitored according to biological laboratory examinations and clinical symptoms
Time frame: through study completion, an average of 1 year
Gene Expression
Expression patterns of genes putatively associated to early events of HCC carcinogenesis
Time frame: A subgroup of individuals will be monitored also through study completion, an average of 1 year
Adverse drug reactions
Occurrence of Adverse drug reactions in individuals treated with GBE or placebo
Time frame: through study completion, an average of 1 year
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