A Multicenter, Randomized, Double-blind, Placebo-controlled Study to evaluate the efficacy and safety of ginkgo biloba leaf ex. inj. in Salvage treatment for Sudden Deafness Patients
- Conditions
- Diseases of the ear and mastoid process
- Registration Number
- KCT0003292
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 68
1. Aged 20 to 69 years
2. Ipsilateral sensorineural hearing loss
3. Contralateral normal hearing (Pure Tone Audiometry mean average <30dB (0.5, 1, 2, 3 kHz)
4. Patients who started treatment with systemic steroids within 2 weeks from the onset of hearing loss
5. Patients who completed with systemic steroids (prednisolone more than 500mg for up to 2weeks)
6. Patients who visited withing two weeks after previous treatment with an systemic steroid and started treatment with intratympanic steroids within two weeks
7. The difference of Pure Tone Audiometry mean (0.5, 1, 2, 3 kHz) between the contralateral side and affected side after the systemic steroid therapy
8. No other previously treatment for hearing loss
9. Patients with a follow-up of 10 weeks
10. Patients who voluntarily sigend the research agreement
The exclusion criteria were as follows:
1. Patients with severe kidney, liver, or respiratory problems
2. Patients with severe heart failure
3. Patients with a history of myocardial infarction within 4 weeks
4. Pregnant and lactating women or pregnant women
5. Patients who had allergic reactions or adverse reactions to Ginkgo materials
6. Sudden hearing loss with whirling type vertigo
7. Patients who participated in clinical trials such as drugs or medical devices within 30 days prior to the screening test
8. Patients who are judged to have problems in participating in research under the judgment of the researcher
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in PTA (pure-tone audiometry) mean threshold (0.5, 1, 2, 3 kHz) at 10th weeks (Visit 7) compared with the baseline
- Secondary Outcome Measures
Name Time Method Changes in PTA (pure-tone audiometry) mean threshold (0.5, 1, 2, 3 kHz) at 3th and 6th weeks, Changes in SA(SRT, WRS), recovery rates of PTA and SA, Chages in THI, SF®-36 at 3th, 6th, and 10th weeks