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A randomized control clinical study of intratympanic injection of monosialotetrahexosylganglioside sodium injection combined with retroauricular injection of methylprednisolone on refractory sudden deafness

A randomized control clinical study of intratympanic injection of monosialotetrahexosylganglioside sodium injection combined with retroauricular injection of methylprednisolone on refractory sudden deafness

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063412
Enrollment
Unknown
Registered
2022-09-06
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Sudden sensorineural hearing loss

Interventions

Experimental group: intratympanic injection of monosialotetrahexosylganglioside sodium injection combined with retroauricular injection of methylprednisolone
Control group:retroauricular injection of methylprednisolone

Sponsors

Nanjing Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients with sudden deafness who meet the 2015 diagnostic criteria of the Chinese Medical Association, the Chinese Society of Otolaryngology-Head and Neck Surgery, have no family history of sensorineural deafness, have onset within 15-42 days, have had 10 days of ineffective conventional treatment (PTA improvement 60 dB, and aged 18-65 years; 2. Agree to participate in this study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Sudden deafness in both ears; 2. Moderate or greater sensorineural deafness (PTA (0.5-4 kHz) > 40 dB) in the contralateral ear; 3. Poor compliance and dropouts; 4. Patients with severe vertigo; 5. Patients who cannot be followed up; 6. Patients with contraindications to the use of medication.

Design outcomes

Primary

MeasureTime frame
pure-tone threshold testing;

Countries

China

Contacts

Public ContactShe Wandong

Nanjing Drum Tower Hospital

shewandong@163.com+86 13701402442

Outcome results

None listed

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