Effect of Ginkgo Biloba extract in comparison with placebo on prevention of tinnitus and ototoxicity in patients treated with cisplati
Phase 3
Recruiting
- Conditions
- Prevention of ototoxicity of cisplatin.Ototoxic hearing loss
- Registration Number
- IRCT2015020720982N1
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
People over the age of 18 candidates for treatment with cisplatin regimen for first time
Exclusion criteria:
Middle ear disorders
Head and neck cancers
Gastrointestinal problems
Tendency to bleeding
Concomitant use of other ototoxic drugs
History of Ginkgo Biloba consumption
Inability to record DPOAE
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method DPOAE. Timepoint: Before beginning of each chemotherapy course and 6 month after ending. Method of measurement: By Audiometry devise in decibel scale.;Tinnitus severity. Timepoint: Before beginning of each chemotherapy course and 6 month after ending. Method of measurement: From 0 to 100.;Ototoxicity severity. Timepoint: Before beginning of each chemotherapy course and 6 month after ending. Method of measurement: By Pure tone audiometry grading from 0 to 4.
- Secondary Outcome Measures
Name Time Method