Safety of Ginkgo Biloba Leaf Extract

Healthy Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03004508
• Other study ID #: IDN5933
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 20, 2016
• Last updated: December 29, 2016
• Start date: July 2015
• Est. completion date: January 2017

Study information

• Verified date: December 2016
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 66
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Gingko Biloba Extract
120mg/day, twice a day, 6 month
• Placebo
120mg/day, twice a day, 6 month

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele Pisana	Rome

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS San Raffaele	Indena S.p.A

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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 — View Citation

Collins A, Koppen G, Valdiglesias V, Dusinska M, Kruszewski M, Møller 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 Mut — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DNA Damage	DNA Damage assessed with the Comet assay as proportion of DNA in the tail	through study completion, an average of 1 year
Primary	Micronucleus frequency	Micronucleus frequency (MN) in peripheral blood lymphocytes (Frequency per 1000 binucleated cells)	through study completion, an average of 1 year
Secondary	Clinical assessment	Complete clinical assessment at the beginning and at the end of the study by physiological parameters	through study completion, an average of 1 year
Secondary	Liver functions	Liver functions will be monitored according to biological laboratory examinations and clinical symptoms	through study completion, an average of 1 year
Secondary	Gene Expression	Expression patterns of genes putatively associated to early events of HCC carcinogenesis	A subgroup of individuals will be monitored also through study completion, an average of 1 year
Secondary	Adverse drug reactions	Occurrence of Adverse drug reactions in individuals treated with GBE or placebo	through study completion, an average of 1 year