Skip to content

A randomized, open, controlled, multicenter clinical trial of intratympanic injection of dexamethasone palmitate in the treatment of sudden deafness

A randomized, open, controlled, multicenter clinical trial of intratympanic injection of dexamethasone palmitate in the treatment of sudden deafness

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056554
Enrollment
Unknown
Registered
2022-02-07
Start date
2022-03-01
Completion date
Unknown
Last updated
2024-10-07

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 dexamethasone palmitate
Control group:Intratympanic injection of dexamethasone sodium phosphate

Sponsors

Eye, Ear, Nose and Throat Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years; 2. Patients with unilateral hearing loss who meet the diagnostic criteria for sudden deafness; 3. The onset time of sudden deafness is within 3 weeks, and special treatment (hormone, thrombolytic and microcirculation improving drugs, etc.) has not been taken; 4. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with total deafness, conductive deafness and mixed deafness; 2. Patients with other ear diseases; 3. Patients with severe cardiac insufficiency or renal failure or respiratory failure; 4. Patients with stage II hypertension or above (systolic blood pressure >160mmHg, diastolic blood pressure >100mmHg); 5. Glaucoma; 6. Patients who have not recovered from visceral surgery or have sequelae after visceral surgery; 7. Gastric and duodenal ulcers; 8. Abnormal electrolyte metabolism; 9. Patients with diabetes or other endocrine system diseases; 10. Patients with severe hematological diseases or tumors (especially acoustic neuroma patients); 11. Patients who are allergic to the prescribed medication; 12. Mental disorders and other patients who cannot cooperate with medication and examination; 13. Patients who are nursing, pregnant or likely to become pregnant; 14. Have participated in any clinical drug trials in the past three months; 15. The investigator deemed it inappropriate for this trial.

Design outcomes

Primary

MeasureTime frame
Hearing level;

Countries

China

Contacts

Public ContactRen Dongdong

Eye, Ear, Nose and Throat Hospital of Fudan University

dongdong_ren@163.com+86 13801913332

Outcome results

None listed

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