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Safety of Ginkgo Biloba Leaf Extract (GiBiEx)

Primary Purpose

Healthy

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Gingko Biloba Extract
Placebo
Sponsored by
IRCCS San Raffaele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy focused on measuring Ginkgo Biloba Extract, Safety, Genomic Stability, DNA cell maintenance

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IRCCS San Raffaele Pisana

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Gingko biloba Extract

Placebo

Arm Description

Outcomes

Primary Outcome Measures

DNA Damage
DNA Damage assessed with the Comet assay as proportion of DNA in the tail
Micronucleus frequency
Micronucleus frequency (MN) in peripheral blood lymphocytes (Frequency per 1000 binucleated cells)

Secondary Outcome Measures

Clinical assessment
Complete clinical assessment at the beginning and at the end of the study by physiological parameters
Liver functions
Liver functions will be monitored according to biological laboratory examinations and clinical symptoms
Gene Expression
Expression patterns of genes putatively associated to early events of HCC carcinogenesis
Adverse drug reactions
Occurrence of Adverse drug reactions in individuals treated with GBE or placebo

Full Information

First Posted
December 20, 2016
Last Updated
December 29, 2016
Sponsor
IRCCS San Raffaele
Collaborators
Indena S.p.A
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1. Study Identification

Unique Protocol Identification Number
NCT03004508
Brief Title
Safety of Ginkgo Biloba Leaf Extract
Acronym
GiBiEx
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 Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele
Collaborators
Indena S.p.A

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Ginkgo Biloba Extract, Safety, Genomic Stability, DNA cell maintenance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gingko biloba Extract
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Gingko Biloba Extract
Other Intervention Name(s)
IDN 5933
Intervention Description
120mg/day, twice a day, 6 month
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
120mg/day, twice a day, 6 month
Primary Outcome Measure Information:
Title
DNA Damage
Description
DNA Damage assessed with the Comet assay as proportion of DNA in the tail
Time Frame
through study completion, an average of 1 year
Title
Micronucleus frequency
Description
Micronucleus frequency (MN) in peripheral blood lymphocytes (Frequency per 1000 binucleated cells)
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Clinical assessment
Description
Complete clinical assessment at the beginning and at the end of the study by physiological parameters
Time Frame
through study completion, an average of 1 year
Title
Liver functions
Description
Liver functions will be monitored according to biological laboratory examinations and clinical symptoms
Time Frame
through study completion, an average of 1 year
Title
Gene Expression
Description
Expression patterns of genes putatively associated to early events of HCC carcinogenesis
Time Frame
A subgroup of individuals will be monitored also through study completion, an average of 1 year
Title
Adverse drug reactions
Description
Occurrence of Adverse drug reactions in individuals treated with GBE or placebo
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Bonassi, PhD
Organizational Affiliation
IRCCS San Raffaele
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS San Raffaele Pisana
City
Rome
ZIP/Postal Code
00166
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23652021
Citation
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.
Results Reference
result
PubMed Identifier
23410167
Citation
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.
Results Reference
result
PubMed Identifier
25446328
Citation
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.
Results Reference
result
PubMed Identifier
12213959
Citation
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.
Results Reference
result
PubMed Identifier
16973674
Citation
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.
Results Reference
result
PubMed Identifier
24184488
Citation
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.
Results Reference
result
PubMed Identifier
29357859
Citation
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.
Results Reference
derived

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Safety of Ginkgo Biloba Leaf Extract

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