Safety of Ginkgo Biloba Leaf Extract

Study Overview
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Brief Summary
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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
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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).

Official Title
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Antioxidant Effect of Treatment With Ginkgo Biloba L. Leaf Extract (IDN 5933) on DNA Cell Maintenance and Genomic Stability: A Randomised Study Versus Placebo

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Gingko Biloba Extract
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gingko biloba Extract<br> | Dietary Supplement: Gingko Biloba Extract<br>* 120mg/day, twice a day, 6 month<br>* Other names: IDN 5933;|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* 120mg/day, twice a day, 6 month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DNA Damage | DNA Damage assessed with the Comet assay as proportion of DNA in the tail | through study completion, an average of 1 year | 
| Micronucleus frequency | Micronucleus frequency (MN) in peripheral blood lymphocytes (Frequency per 1000 binucleated cells) | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical assessment | Complete clinical assessment at the beginning and at the end of the study by physiological parameters | through study completion, an average of 1 year | 
| Liver functions | Liver functions will be monitored according to biological laboratory examinations and clinical symptoms | through study completion, an average of 1 year | 
| Gene Expression | Expression patterns of genes putatively associated to early events of HCC carcinogenesis | 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 | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ginkgo Biloba Extract, Safety, Genomic Stability, DNA cell maintenance