Safety of Ginkgo Biloba Leaf Extract (GiBiEx)
Healthy
About this trial
This is an interventional treatment trial for Healthy focused on measuring Ginkgo Biloba Extract, Safety, Genomic Stability, DNA cell maintenance
Eligibility Criteria
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
Sites / Locations
- IRCCS San Raffaele Pisana
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Gingko biloba Extract
Placebo