A Phase 2 interventional study of Gingko Biloba Extract and Placebo in Healthy, sponsored by IRCCS San Raffaele. Status unknown at 1 site in Italy. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2016-12-30.
Sponsored by IRCCS San Raffaele · Phase 2, Interventional, and Treatment
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:
Secondary Endpoints:
IRCCS San Raffaele is the lead sponsor of 443 studies on the registry; 234 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Dietary Supplement: Gingko Biloba Extract
Dietary Supplement: Placebo
120mg/day, twice a day, 6 month
Also known as: IDN 5933
120mg/day, twice a day, 6 month
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
Plan to share: Undecided
This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Genomic Instability
IRCCS San Raffaele