The Protective Effect of Ginkgo Biloba Extract on Cisplatin-induced Ototoxicity in Humans

PHASE2CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

June 30, 2008

Study Completion Date

June 30, 2008

Conditions
OtotoxicityHearing Loss
Interventions
DRUG

Ginkgo Biloba Extract (GBE761)

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.

DRUG

Placebo

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.

Trial Locations (1)

70000-000

Hospital de Base do Distrito Federal (HBDF), Brasília

All Listed Sponsors
lead

University of Brasilia

OTHER

NCT01139281 - The Protective Effect of Ginkgo Biloba Extract on Cisplatin-induced Ototoxicity in Humans | Biotech Hunter | Biotech Hunter