MedTrace Logo

Safety of Ginkgo Biloba Leaf Extract

NCT03004508 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2016-12-30

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DIETARY_SUPPLEMENT

Gingko Biloba Extract

120mg/day, twice a day, 6 month

DIETARY_SUPPLEMENT

Placebo

120mg/day, twice a day, 6 month

Sponsors & Collaborators

  • Indena S.p.A

    collaborator INDUSTRY

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • Stefano Bonassi, PhD · IRCCS San Raffaele

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-12-31
Completion
2017-01-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03004508 on ClinicalTrials.gov