Healthy
Conditions
Keywords
Ginkgo Biloba Extract, Safety, Genomic Stability, DNA cell maintenance
Brief summary
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.
Detailed description
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).
Interventions
DIETARY_SUPPLEMENTGingko Biloba Extract
120mg/day, twice a day, 6 month
DIETARY_SUPPLEMENTPlacebo
120mg/day, twice a day, 6 month
Sponsors
Indena S.p.A
IRCCS San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female senior, residents of nursing homes, with no known clinically significant pathology as assessed by the investigator * Life expectancy of greater than 1 year * Subjects must have given written informed consent in accordance with ICH-GCP (International Conference on Harmonization - Good Clinical Practice) and local laws and regulations To perform the experiment in a typical population treated with Ginkgo biloba L. leaf extract ( IDN 5933) the study will be performed among the residents of nursing homes among the structures of the San Raffaele network, i.e., The San Raffaele Montecompatri, the San Raffaele Rocca di Papa and the San Raffaele Sabaudia . The use of institutionalised subjects will allow a good compliance to the treatment, which will be administered by the nursing homes nurses. Subjects meeting inclusion criteria and signing the informed consent will be randomised to receive 120-mg/twice per day of Ginkgo biloba L. leaf extract ( IDN 5933) or placebo.
Exclusion criteria
* Life expectancy of less than 1 year * Treatment with anticoagulant and antiplatelet drugs in subjects with previous report of increased bleeding tendency * Cognitive impairment * Refuse to sign the informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DNA Damage | through study completion, an average of 1 year | DNA Damage assessed with the Comet assay as proportion of DNA in the tail |
| Micronucleus frequency | through study completion, an average of 1 year | Micronucleus frequency (MN) in peripheral blood lymphocytes (Frequency per 1000 binucleated cells) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical assessment | through study completion, an average of 1 year | Complete clinical assessment at the beginning and at the end of the study by physiological parameters |
| Liver functions | through study completion, an average of 1 year | Liver functions will be monitored according to biological laboratory examinations and clinical symptoms |
| Gene Expression | A subgroup of individuals will be monitored also through study completion, an average of 1 year | Expression patterns of genes putatively associated to early events of HCC carcinogenesis |
| Adverse drug reactions | through study completion, an average of 1 year | Occurrence of Adverse drug reactions in individuals treated with GBE or placebo |
Countries
Italy
Outcome results
None listed