None listed
Conditions
Interventions
Drug : Randomized block design (block size 6) was used so that important indices, that were expected to have an influence on efficacy endpoints, could be evenly distributed between the two groups. Eac
normal saline (550 mL) was used in the placebo group. Oral EGb761 (Tanamin®) tablets (160 mg/day, twice daily) were administered in both groups from day 15 to day 28.
Sponsors
Yuyu Phama
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with sudden deafness 2. Patients who visited the hospital within 1 week from the day of symptom onset 3. Patients aged between 20 and 70 4. Patients without a history of other treatments for hearing loss 5. Patients who are available for a 28-day follow-up 6. Patients who provided a voluntary written agreement for study participation
Exclusion criteria
Exclusion criteria: 1. Patients with a severe renal, hepatic or respiratory disease 2. Patients with heart failure 3. Patients with a history of myocardial infarction within the previous 4 weeks 4. Pregnancy, breast-feeding, or child-bearing potential 5. Patients with known allergic reaction or adverse event to ginkgo leaf 6. Patients with sudden deafness with rotatory vertigo 7. Patients who had participated in another clinical trial of a drug or medical device within 30 days before screening 8. Patients who are deemed not appropriate for participation on the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pure-tone audiometry (PTA) | — |
Secondary
| Measure | Time frame |
|---|---|
| Speech audiometry (SA) ;Tinnitus Handicap inventory (THI);Quality of Life scale (SF®-36) | — |
Countries
Korea, Republic of
Contacts
Public ContactMun Young Chang
Seoul National University Hospital
Outcome results
None listed