Clinical Trial: Safety of Ginkgo Biloba Leaf Extract

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary:

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).

Sponsor: IRCCS San Raffaele

Current Primary Outcome:

• DNA Damage [ Time Frame: through study completion, an average of 1 year ]
  DNA Damage assessed with the Comet assay as proportion of DNA in the tail
• Micronucleus frequency [ Time Frame: through study completion, an average of 1 year ]
  Micronucleus frequency (MN) in peripheral blood lymphocytes (Frequency per 1000 binucleated cells)

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Clinical assessment [ Time Frame: 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 [ Time Frame: through study completion, an average of 1 year ]
  Liver functions will be monitored according to biological laboratory examinations and clinical symptoms
• Gene Expression [ Time Frame: 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 [ Time Frame: through study completion, an average of 1 year ]
  Occurrence of Adverse drug reactions in individuals treated with GBE or placebo

Original Secondary Outcome:

• Clinical assessment [ Time Frame: through study completion, an average of 1 year ]
  Complete clinical assessment at the beginning and at the end of the study
• Liver functions [ Time Frame: through study completion, an average of 1 year ]
  Liver functions will be monitored according to biological laboratory examinations and clinical symptoms
• Gene Expression [ Time Frame: A subgroup of individuals will be monitored also fthrough study completion, an average of 1 year ]
  Expression patterns of genes putatively associated to early events of HCC carcinogenesis
• Adverse drug reactions [ Time Frame: through study completion, an average of 1 year ]
  Occurrence of Adverse drug reactions in individuals treated with GBE or placebo

Information By: IRCCS San Raffaele

Dates:
Date Received: December 20, 2016
Date Started: July 2015
Date Completion: January 2017
Last Updated: December 29, 2016
Last Verified: December 2016