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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

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.


Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Gingko Biloba Extract Dietary Supplement: Placebo Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : July 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gingko biloba Extract Dietary Supplement: Gingko Biloba Extract
120mg/day, twice a day, 6 month
Other Name: IDN 5933

Placebo Comparator: Placebo Dietary Supplement: Placebo
120mg/day, twice a day, 6 month




Primary Outcome Measures :
  1. 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

  2. Micronucleus frequency [ Time Frame: through study completion, an average of 1 year ]
    Micronucleus frequency (MN) in peripheral blood lymphocytes (Frequency per 1000 binucleated cells)


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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 from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03004508


Locations
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Italy
IRCCS San Raffaele Pisana
Rome, Italy, 00166
Sponsors and Collaborators
IRCCS San Raffaele
Indena S.p.A
Investigators
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Principal Investigator: Stefano Bonassi, PhD IRCCS San Raffaele

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stefano Bonassi, Head, Clinical and Molecular Epidemiology, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT03004508    
Other Study ID Numbers: IDN5933
First Posted: December 29, 2016    Key Record Dates
Last Update Posted: December 30, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Stefano Bonassi, IRCCS San Raffaele:
Ginkgo Biloba Extract
Safety
Genomic Stability
DNA cell maintenance
Additional relevant MeSH terms:
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Genomic Instability
Pathologic Processes