HealthyPhase 2GiBiExNCT03004508
Safety of Ginkgo Biloba Leaf Extract
A Phase 2 study testing Gingko Biloba Extract in people with Healthy, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Healthy
- What is being tested?
- Gingko Biloba Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2015to Jan 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Healthy
- Being tested
- Gingko Biloba Extract, Placebo
- Keywords
- Ginkgo Biloba Extract, Safety, Genomic Stability, DNA cell maintenance
- Medical subject headings
- Genomic Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingko Biloba ExtractDietary supplement
Also called IDN 5933
120mg/day, twice a day, 6 month
PlaceboDietary supplement
120mg/day, twice a day, 6 month
| Study group | Role | What they receive |
|---|---|---|
| Gingko biloba Extract | Experimental | Not described Receives: Dietary Supplement: Gingko Biloba Extract |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA Damage
DNA Damage assessed with the Comet assay as proportion of DNA in the tail
Measured: through study completion, an average of 1 year
Micronucleus frequency
Micronucleus frequency (MN) in peripheral blood lymphocytes (Frequency per 1000 binucleated cells)
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Clinical assessment
Complete clinical assessment at the beginning and at the end of the study by physiological parameters
Measured: through study completion, an average of 1 year
Liver functions
Liver functions will be monitored according to biological laboratory examinations and clinical symptoms
Measured: through study completion, an average of 1 year
Gene Expression
Expression patterns of genes putatively associated to early events of HCC carcinogenesis
Measured: A subgroup of individuals will be monitored also through study completion, an average of 1 year
Adverse drug reactions
Occurrence of Adverse drug reactions in individuals treated with GBE or placebo
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startJul 2015
- Primary completionDec 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Indena S.p.A
- Responsible party
- Principal investigator, Stefano Bonassi, IRCCS San Raffaele
- Investigators
- Stefano Bonassi, PhD, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004508
- Sponsor's protocol ID
- IDN5933
- Acronym
- GiBiEx
- Status last verified
- Dec 2016
- First submitted
- 20 Dec 2016
- Last updated
- 30 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23652021Russo 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.
PubMed 23410167Heinonen 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.
PubMed 25446328Luo 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.
PubMed 12213959Bonassi 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.
PubMed 16973674Collins 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.
PubMed 24184488Bonassi 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.
PubMed 29357859
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03004508
- Acronym / sponsor ID
- GiBiEx / IDN5933
- Conditions
- Healthy
- Keywords
- Ginkgo Biloba Extract, Safety, Genomic Stability, DNA cell maintenance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Indena S.p.A
- Study start
- Jul 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 29 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gingko biloba Extract | Experimental | Dietary Supplement: Gingko Biloba Extract |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gingko Biloba ExtractAlso: IDN 5933120mg/day, twice a day, 6 month | Dietary supplement | Gingko biloba Extract |
| Placebo120mg/day, twice a day, 6 month | Dietary supplement | Placebo |
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)
4 secondary outcomes
Clinical assessment
Time frame: through study completion, an average of 1 year
Liver functions
Time frame: through study completion, an average of 1 year
Gene Expression
Time frame: A subgroup of individuals will be monitored also through study completion, an average of 1 year
Adverse drug reactions
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2016.
- Results publication: PubMed 23652021National 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 publication: PubMed 23410167Russo 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 publication: PubMed 25446328Heinonen 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 publication: PubMed 12213959Luo 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 publication: PubMed 16973674Bonassi 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 publication: PubMed 24184488Collins 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.
- Derived from this study: PubMed 29357859Bonassi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Bonassi, PhD principal investigator
IRCCS San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gingko Biloba Extract in people with Healthy, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DNA Damage (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03004508, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2016.