Effect of Ginkgo Biloba extract in comparison with placebo on prevention of tinnitus and ototoxicity in patients treated with cisplatin

Effect of Ginkgo Biloba extract in comparison with placebo on prevention of tinnitus and otoxicity in patients treated with cisplatin

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015020720982N1

Enrollment

Registered

2015-11-02

Start date

2015-11-01

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of ototoxicity of cisplatin. Ototoxic hearing loss

Interventions

Intervention 1: Intervention group: Ginckgo Biloba prescription (2 tablets per 8 hours). Intervention 2: Control Group: Placebo prescription, 2 tablets per 8 hours.

Treatment - Drugs

Intervention group: Ginckgo Biloba prescription (2 tablets per 8 hours)

Control Group: Placebo prescription, 2 tablets per 8 hours

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
???Drug side effects including Gastrointestinal and bleeding. Timepoint: Whole period of Ginkgo Biloba consumption. Method of measurement: Questionnaire.;Age. Timepoint: Before entering to study. Method of measurement: Questionnaire.;Sex. Timepoint: Before entering to study. Method of measurement: Questionnaire.;Anxiety. Timepoint: Before beginning of each chemotherapy course and 6 month after ending. Method of measurement: Anxiety questennaire.;Self esteem. Timepoint: Before beginning of each chemotherapy course and 6 month after ending. Method of measurement: Self esteem questionnaire.;Depression. Timepoint: Before beginning of each chemotherapy course and 6 month after ending. Method of measurement: Depression questionnare.;Cis platin dose. Timepoint: Before beginning of each chemotherapy course. Method of measurement: In mg/ mm2.;Cancer type. Timepoint: Before entering to study. Method of measurement: Pathology report.;Medical history. Timepoint: Before entering to study. Method of measurement: Questionnaire.;Drug history. Timepoint: Before beginning of each chemotherapy course and 6 month after ending. Method of measurement: Questionnaire.;Renal and liver laboratory data. Timepoint: Before beginning of each chemotherapy course and 6 month after ending. Method of measurement: Laboratory ( Urea, Creatinin and liver enzymes).	—

Measure

Time frame

???Drug side effects including Gastrointestinal and bleeding. Timepoint: Whole period of Ginkgo Biloba consumption. Method of measurement: Questionnaire.;Age. Timepoint: Before entering to study. Method of measurement: Questionnaire.;Sex. Timepoint: Before entering to study. Method of measurement: Questionnaire.;Anxiety. Timepoint: Before beginning of each chemotherapy course and 6 month after ending. Method of measurement: Anxiety questennaire.;Self esteem. Timepoint: Before beginning of each chemotherapy course and 6 month after ending. Method of measurement: Self esteem questionnaire.;Depression. Timepoint: Before beginning of each chemotherapy course and 6 month after ending. Method of measurement: Depression questionnare.;Cis platin dose. Timepoint: Before beginning of each chemotherapy course. Method of measurement: In mg/ mm2.;Cancer type. Timepoint: Before entering to study. Method of measurement: Pathology report.;Medical history. Timepoint: Before entering to study. Method of measurement: Questionnaire.;Drug history. Timepoint: Before beginning of each chemotherapy course and 6 month after ending. Method of measurement: Questionnaire.;Renal and liver laboratory data. Timepoint: Before beginning of each chemotherapy course and 6 month after ending. Method of measurement: Laboratory ( Urea, Creatinin and liver enzymes).

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Countries

Iran (Islamic Republic of)

Contacts

Public Contact?Dr Mahtab Rabbani Anari

Theran University of Medical Sceinces

m_rabani@razi.tums.ac.ir+98 21 6119 2393

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026