The efficacy and safety of systemic injection of Ginkgo biloba extract, EGb761, in idiopathic sudden sensorineural hearing loss: a randomized placebo-controlled clinical trial
- Conditions
- Diseases of the ear and mastoid process
- Registration Number
- KCT0001381
- Lead Sponsor
- Yuyu Phama
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pure-tone audiometry (PTA)
- Secondary Outcome Measures
Name Time Method Speech audiometry (SA) ;Tinnitus Handicap inventory (THI);Quality of Life scale (SF®-36)