The Protective Effect of Ginkgo Biloba Extract on Cisplatin-induced Ototoxicity in Humans
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|ClinicalTrials.gov Identifier: NCT01139281|
Recruitment Status : Completed
First Posted : June 8, 2010
Last Update Posted : June 8, 2010
|Condition or disease||Intervention/treatment||Phase|
|Ototoxicity Hearing Loss||Drug: Ginkgo Biloba Extract (GBE761) Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Protective Effect of Ginkgo Biloba Extract on Cisplatin-Induced Ototoxicity in Humans Beings Evaluated by Distortion Product Otoacoustic Emissions|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
Active Comparator: Study Group
The Study Group(SG) received Ginkgo biloba extract(GBE761)(240mg/day)plus cisplatin(CDDP)
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.
Other Name: Study Group
Placebo Comparator: Control Group(CG)
The Control Group received Placebo plus CDDP
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.
Other Name: Control Group
- the effect of GBE761 as a possible protector against cisplatin (CDDP) induced hearing loss was evaluated through the DPOAE. Comparisons were made between baseline measurements and those records after maximum cumulative CDDP dosage. [ Time Frame: the patients were followed about ninety days ]The protective effect of GBE761 on CDDP induced ototoxicity in human beings was evaluated with DPOAE mean amplitudes and signal-to-noise ratio (SNR) values at in the frequencies ranging from 1 to 8KHz in the study and control groups, between before and after cumulative CDDP injections, in order to evaluate the significant differences in DPOAE results, and so to differentiate hearing status ( normal hearing or hearing loss) while the subjects were taking GBE or placebo.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01139281
|Hospital de Base do Distrito Federal (HBDF)|
|Brasília, DF, Brazil, 70000-000|
|Principal Investigator:||Mirela A Dias||University of Brasília|
|Study Chair:||Carlos CP Oliveira||University of Brasília|