NCT03004508

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P25-P50 for phase_2 healthy

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 29, 2016

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

December 30, 2016

Status Verified

December 1, 2016

Enrollment Period

1.4 years

First QC Date

December 20, 2016

Last Update Submit

December 29, 2016

Conditions

Healthy

Keywords

Ginkgo Biloba ExtractSafetyGenomic StabilityDNA cell maintenance

Outcome Measures

Primary Outcomes (2)

  • DNA Damage

    DNA Damage assessed with the Comet assay as proportion of DNA in the tail

    through study completion, an average of 1 year

  • Micronucleus frequency

    Micronucleus frequency (MN) in peripheral blood lymphocytes (Frequency per 1000 binucleated cells)

    through study completion, an average of 1 year

Secondary Outcomes (4)

  • Clinical assessment

    through study completion, an average of 1 year

  • Liver functions

    through study completion, an average of 1 year

  • Gene Expression

    A subgroup of individuals will be monitored also through study completion, an average of 1 year

  • Adverse drug reactions

    through study completion, an average of 1 year

Study Arms (2)

Gingko biloba Extract

EXPERIMENTAL
Dietary Supplement: Gingko Biloba Extract

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Gingko Biloba ExtractDIETARY_SUPPLEMENT

120mg/day, twice a day, 6 month

Also known as: IDN 5933
Gingko biloba Extract
PlaceboDIETARY_SUPPLEMENT

120mg/day, twice a day, 6 month

Placebo

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS San Raffaele Pisana

Rome, 00166, Italy

Location

Related Publications (7)

  • National Toxicology Program. Toxicology and carcinogenesis studies of Ginkgo biloba extract (CAS No. 90045-36-6) in F344/N rats and B6C3F1/N mice (Gavage studies). Natl Toxicol Program Tech Rep Ser. 2013 Mar;(578):1-183.

    PMID: 23652021RESULT

  • Russo P, Frustaci A, Del Bufalo A, Fini M, Cesario A. Multitarget drugs of plants origin acting on Alzheimer's disease. Curr Med Chem. 2013;20(13):1686-93. doi: 10.2174/0929867311320130008.

    PMID: 23410167RESULT

  • Heinonen T, Gaus W. Cross matching observations on toxicological and clinical data for the assessment of tolerability and safety of Ginkgo biloba leaf extract. Toxicology. 2015 Jan 2;327:95-115. doi: 10.1016/j.tox.2014.10.013. Epub 2014 Nov 11.

    PMID: 25446328RESULT

  • Luo Y, Smith JV, Paramasivam V, Burdick A, Curry KJ, Buford JP, Khan I, Netzer WJ, Xu H, Butko P. Inhibition of amyloid-beta aggregation and caspase-3 activation by the Ginkgo biloba extract EGb761. Proc Natl Acad Sci U S A. 2002 Sep 17;99(19):12197-202. doi: 10.1073/pnas.182425199. Epub 2002 Sep 4.

    PMID: 12213959RESULT

  • Bonassi S, Znaor A, Ceppi M, Lando C, Chang WP, Holland N, Kirsch-Volders M, Zeiger E, Ban S, Barale R, Bigatti MP, Bolognesi C, Cebulska-Wasilewska A, Fabianova E, Fucic A, Hagmar L, Joksic G, Martelli A, Migliore L, Mirkova E, Scarfi MR, Zijno A, Norppa H, Fenech M. An increased micronucleus frequency in peripheral blood lymphocytes predicts the risk of cancer in humans. Carcinogenesis. 2007 Mar;28(3):625-31. doi: 10.1093/carcin/bgl177. Epub 2006 Sep 14.

    PMID: 16973674RESULT

  • Collins A, Koppen G, Valdiglesias V, Dusinska M, Kruszewski M, Moller P, Rojas E, Dhawan A, Benzie I, Coskun E, Moretti M, Speit G, Bonassi S; ComNet project. The comet assay as a tool for human biomonitoring studies: the ComNet project. Mutat Res Rev Mutat Res. 2014 Jan-Mar;759:27-39. doi: 10.1016/j.mrrev.2013.10.001. Epub 2013 Oct 31.

    PMID: 24184488RESULT

  • Bonassi S, Prinzi G, Lamonaca P, Russo P, Paximadas I, Rasoni G, Rossi R, Ruggi M, Malandrino S, Sanchez-Flores M, Valdiglesias V, Benassi B, Pacchierotti F, Villani P, Panatta M, Cordelli E. Clinical and genomic safety of treatment with Ginkgo biloba L. leaf extract (IDN 5933/Ginkgoselect(R)Plus) in elderly: a randomised placebo-controlled clinical trial [GiBiEx]. BMC Complement Altern Med. 2018 Jan 22;18(1):22. doi: 10.1186/s12906-018-2080-5.

    PMID: 29357859DERIVED

MeSH Terms

Conditions

Genomic Instability

Interventions

Ginkgo Extract

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant ExtractsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Stefano Bonassi, PhD

    IRCCS San Raffaele

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Clinical and Molecular Epidemiology

Study Record Dates

First Submitted

December 20, 2016

First Posted

December 29, 2016

Study Start

July 1, 2015

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

December 30, 2016

Record last verified: 2016-12

Locations

IT(1)