Sudden Hearing Loss Multi-center Clinical Trial

Study Overview
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Brief Summary
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The incidence of sudden hearing loss is rising obviously resent year, Glucocorticoids have obtained obvious effect in the treatment of sudden deafness. Postauricular hypodermic injection is the latest findings in clinical work and a new noninvasive way of administration which is gradually expanding research. The aim of this experiment is to verify and explore the efficacy and safety of the postauricular injection treatment with different doses of Glucocorticoids.

Official Title
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Glucocorticoid Postauricular Injection Treatment for Sudden Hearing Loss: a Multi-center, Opened, Randomized, Controlled Clinical Trial

Conditions
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Full-frequency Sudden Hearing Loss

Intervention / Treatment
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* Drug: Dexamethasone Phosphate
* Drug: Dexamethasone Phosphate
* Drug: Ginaton


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older than 18 years, less than 60 years old; patient with unilateral or bilateral（occured successively) acute sensorineural hearing loss(ASNHL) with onset 72hours or less ago. Mean hearing loss compared with the unaffected contralateral ear of at leat 60 dB; Primary presentation within 2weeks; standard treatment for 2 weeks; After 2weeks of standard treatment, sensorineural hearing loss (SHL) curative effect evaluation damaged frequencies >/=30 dB better than before; Written informed consent before participation in the study. Exclusion Criteria: SYSTEMIC DISEASE History of tuberculosis or positive purified protein derivative (PPD); Insulin-dependent diabetes mellitus; Hypertension, poor control of BP(SBP/DBP)>=140mmHg); History of rheumatic disease, e.g. rheumatoid arthritis, scleroderma, lupus, etc; Serious psychiatric disease or psychiatric reaction to corticosteroids; History of heart disease or transient ischemic attacks(TIAs); Prior treatment with chemotherapeutic or immunosuppressive drugs; Pancreatitis; Active peptic ulcer disease or history of gastrointestinal bleeding; History of HIV, Hepatitis B or C; Chronic kidney failure; Alcohol abuse; Active shingles; Severe osteoporosis or non-surgical aseptic necrosis of the hip; Without contraindication with glucocorticoid, ginaton, Batroxobin. OTOLOGIC DISEASE History of Meniere's disease; History of chronic ear infection; Prior history of sudden sensorineural hearing loss (SSNHL); History of fluctuating hearing loss.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: regular treatment comparator<br>Ginaton | Drug: Ginaton<br>* 40mg/pill, 3times/day,oral<br>|
| Experimental: Dexamethasone Phosphate low dose<br>5mg | Drug: Dexamethasone Phosphate<br>* 5mg; postauricular injection<br>|
| Experimental: Dexamethasone Phosphate high dose<br>10mg | Drug: Dexamethasone Phosphate<br>* 10mg; postauricular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pure tone audiometry test | Average change in hearing loss in decibel(dB) between the baseline and D 30 for the three contiguous frequencies with the worst hearing loss, and the treatment efficiency of the 30th day. | Days 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus with Evaluation questionnaire | Average change in hearing loss in dB between the baseline and D 14, 90 for the three contiguous frequencies with the worst hearing loss; the treatment efficiency of the D 14,90; the treatment efficiency of the tinnitus in D14, 30, 90. | days 14,30,90 | 
| Vertigo with Evaluation questionnaire | Average change in hearing loss in dB between the baseline and D 14, 90 for the three contiguous frequencies with the worst hearing loss; the treatment efficiency of the D 14,90; the treatment efficiency of the vertigo in D14, 30, 90. | Day 14,30,90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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full-frequency sudden hearing loss, post auricular injection, glucocorticoid, multi-center