Safety of Ginkgo Biloba Leaf Extract (GiBiEx)

December 29, 2016 updated by: Stefano Bonassi, IRCCS San Raffaele

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00166
        • IRCCS San Raffaele Pisana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
120mg/day, twice a day, 6 month
Experimental: Gingko biloba Extract
Dietary supplement: Gingko Biloba Extract
120mg/day, twice a day, 6 month
Other Names:
  • IDN 5933

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 1 year
Micronucleus frequency
Time Frame: through study completion, an average of 1 year
Micronucleus frequency (MN) in peripheral blood lymphocytes (Frequency per 1000 binucleated cells)
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 1 year
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
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
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
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
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Collaborators

Indena S.p.A

Investigators

  • Principal Investigator: Stefano Bonassi, PhD, IRCCS San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

December 20, 2016

First Submitted That Met QC Criteria

December 22, 2016

First Posted (Estimate)

December 29, 2016

Study Record Updates

Last Update Posted (Estimate)

December 30, 2016

Last Update Submitted That Met QC Criteria

December 29, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDN5933

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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