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Clinical efficacy of different treatment routes of methylprednisolone in rescure treatment of sudden deafness: a randomized controlled trial

Rescure treatment of sudden deafness

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000028818
Enrollment
Unknown
Registered
2020-01-04
Start date
2020-02-01
Completion date
Unknown
Last updated
2020-01-06

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

Conditions

Idopathic sudden sensorineural hearing loss

Interventions

experimental group:Apply methylprednisolone 48mg/d throughout the day for 7 days, then gradually reduce the amount for 3 days for a total of 10 days. At the same time, 40 mg / mL methylprednisolone wa
control group:The whole body was treated with methylprednisolone 48mg/d for 7 days, then gradually reduced for 3 days for a total of 10 days.

Sponsors

The First Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Signing informed consent; 2. Age greater than 18 and less than 75 years old; 3. Diagnosis of unilateral sudden sensorineural hearing loss; 4. Sensorineural hearing loss occurred within 3 days, at least in the adjacent two frequencies, the hearing loss exceeds 20dB, usually the cause is unknown, accompanied by tinnitus, ear nausea, dizziness and other symptoms; 5. The recovery of the ISSNHL is insufficient for at least 12 days, regardless of whether the patient receives any treatment (ie, the hearing of the contralateral ear is at least 20 dB higher than the affected ear at at least three frequencies (any three of 500, 1000)).

Exclusion criteria

Exclusion criteria: 1. Positive pregnancy test, risk of pregnancy (insufficient protection or insufficient lactation); 2. Otitis media or effusion, external auditory canal; 3. Conductive hearing loss greater than 10dB; 4. There are any conditions or symptoms that indicate that hearing loss is not ISSNHL, such as acoustic trauma, Meniere's disease, hearing fluctuations, endolymphatic edema, suspected recurrent cochlear lesions, hearing loss due to ear surgery, perilymphatic fistula or barotrauma; 5. The history of ototoxic treatment in the past 6 months, such as chemotherapy, the use of loop diuretics, high doses of aspirin. 6. A history of allergy, allergy or intolerance or any serious abnormal drug reaction to the study drug is known. 7. Any systemic nervous system disease.

Design outcomes

Primary

MeasureTime frame
Pure tone average;

Secondary

MeasureTime frame
Speech recognition rate;

Countries

China

Contacts

Public ContactXianren Wang

Department of Otorhinolaryngology, The First Affiliated Hospital, Sun Yat-Sen University

wangxianrend@126.com+86 13631493016

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026