CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
Ginkgo Biloba Extract (GBE761) +1 moredrug
Likely dose
Ginkgo Biloba Extract (GBE761) 120mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01139281
NCT01139281Phase 2Completed
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The Protective Effect of Ginkgo Biloba Extract on Cisplatin-Induced Ototoxicity in Humans Beings Evaluated by Distortion Product Otoacoustic Emissions

University of Brasilia·interventional·Posted Jun 8, 2010·Updated Jun 8, 2010

In Brief

A Phase 2 clinical trial evaluating Ginkgo Biloba Extract (GBE761) and Placebo for Ototoxicity and Hearing Loss. Completed, enrolled 15 participants across 1 site.

Detailed Summary

The proposal of this study was to evaluate in human beings, using distortion product otoacoustic emission (DPOAE) test, the action of ginkgo biloba extract (GBE761)as a possible ear protective against cisplatin (CDDP) induced hearing loss.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOtotoxicity, Hearing Loss
CountriesBrazil
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 8, 2010
Enrollment StartJun 1, 2007
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 16.1 years ago

Interventions

Ginkgo Biloba Extract (GBE761)drug

The subjects were randomized and allocated in two groups: Control Group(CG) and Study Group(SG). the study group received GBE761(120mg twice a day) plus cisplatin and was guided to ingest GBE761 just before initial cisplatin dosage. The maximum cumulative cisplatin dosage was 300mg/m². They were followed up for ninety days. Comparisons were made between baseline distortion-product otoacoustic emissions measurements and those DPOAE records after maximum cumulative cisplatin dosage.

Placebodrug

The subjects were randomized and allocated in two groups: control group and study group. The control group received placebo plus cisplatin and was guided to ingest Placebo just before initial cisplatin dosage. The maximum cumulative cisplatin dosage was 300mg/m². They were followed up for ninety days. Comparisons were made between baseline distortion-product otoacoustic emissions measurements and those DPOAE records after maximum cumulative cisplatin dosage.