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Safety of Ginkgo Biloba Leaf Extract (GiBiEx)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03004508
Recruitment Status : Unknown
Verified December 2016 by Stefano Bonassi, IRCCS San Raffaele.
Recruitment status was:  Active, not recruiting
First Posted : December 29, 2016
Last Update Posted : December 30, 2016
Sponsor:
Collaborator:
Indena S.p.A
Information provided by (Responsible Party):
Stefano Bonassi, IRCCS San Raffaele

Tracking Information
First Submitted Date  ICMJE December 20, 2016
First Posted Date  ICMJE December 29, 2016
Last Update Posted Date December 30, 2016
Study Start Date  ICMJE July 2015
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2016)
  • 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 Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2016)
  • 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 Measures  ICMJE
 (submitted: December 22, 2016)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of Ginkgo Biloba Leaf Extract
Official Title  ICMJE 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Dietary Supplement: Gingko Biloba Extract
    120mg/day, twice a day, 6 month
    Other Name: IDN 5933
  • Dietary Supplement: Placebo
    120mg/day, twice a day, 6 month
Study Arms  ICMJE
  • Experimental: Gingko biloba Extract
    Intervention: Dietary Supplement: Gingko Biloba Extract
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: December 22, 2016)
66
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2017
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03004508
Other Study ID Numbers  ICMJE IDN5933
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Stefano Bonassi, IRCCS San Raffaele
Study Sponsor  ICMJE IRCCS San Raffaele
Collaborators  ICMJE Indena S.p.A
Investigators  ICMJE
Principal Investigator: Stefano Bonassi, PhD IRCCS San Raffaele
PRS Account IRCCS San Raffaele
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP