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Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03004508
Study type Interventional
Source IRCCS San Raffaele
Status Active, not recruiting
Phase Phase 2
Start date July 2015
Completion date January 2017

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