Efficiency of Systemic Combined with Local Steroid as Initial Therapy for Full-Frequency Sudden Sensorineural Hearing Loss: a Prospective Randomized Controlled Study

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200055605

Enrollment

Unknown

Registered

2022-01-14

Start date

2022-02-01

Completion date

Unknown

Last updated

2023-02-13

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

Conditions

Sudden Hearing Loss

Interventions

Basic Treatment Group:Batroxobin+Ginkgo Biloba Extract+Glucocorticoid i.v.

Basic Treatment Group+Intratympanic injection:Batroxobin+Ginkgo Biloba Extract+Glucocorticoid i.v. and Intratympanic Steroid Therapy

Basic Treatment Group+Postauricular Injection:Batroxobin+Ginkgo Biloba Extract+Glucocorticoid i.v. and Postauricular Steroid Therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years, gender not limited; 2. Meet the diagnostic criteria of sudden sensorineural hearing loss: sudden sensorineural hearing loss with unknown cause within 72 hours, with a decrease in hearing of >= 30 decibels affecting at least 3 consecutive frequencies; 3. The audiometric configuration showed a full-frequency descending in PTA threshold; 4. Onset within 2 weeks without any medical treatment; 5. There are no contraindications to glucocorticoid, lidocaine, ginkgo biloba extract, batroxobin and other drugs; 6. Metabolic diseases such as hypertension, diabetes and blood diseases are not absolute contraindications in this study, but patients with these diseases should be actively treated for the primary disease, and attention should be paid to the contraindication of drug use; 7. The enrolled patients should be hospitalized. If hospitalization is not possible, the clinical examination data of all cases must be complete; 8. All patients are required to sign an informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients have middle ear lesions, meniere's disease, acoustic neuroma and other ear lesions; 2. Definite bilateral hearing asymmetry before the disease; 3. Uncontrolled severe hypertension, diabetes, cerebrovascular diseases and other diseases; 4. Pregnant or lactating women; 5. Patients who could not complete the follow-up; 6. In the opinion of the attending physician or researcher, there are other conditions that are not suitable for participating in this study.

Design outcomes

Primary

Measure	Time frame
Threshold of Pure Tone Audiometry;Word Recognition Score;	—

Countries

China

Contacts

Public ContactYu Lisheng

Department of Otolaryngology, Peking University People's Hospital

yulish68@126.com+86 13910750400

Outcome results

None listed

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