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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003292

Enrollment

Registered

2018-10-25

Start date

2018-11-12

Completion date

Unknown

Last updated

2020-11-03

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

Conditions

None listed

Interventions

Drug : 1. In 68 patients with sudden hearing loss who did not have sufficient treatment effect after systemic steroid therapy. 2. The patients are devided into tow groups (each 34 patients) 1) Intr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Changes in PTA (pure-tone audiometry) mean threshold (0.5, 1, 2, 3 kHz) at 10th weeks (Visit 7) compared with the baseline	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactYehree Kim

Asan Medical Center

Outcome results