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Clinical study of batroxobin injection in the treatment of sudden deafness

Clinical study of batroxobin injection in the treatment of sudden deafness

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038871
Enrollment
Unknown
Registered
2020-10-08
Start date
2020-10-07
Completion date
Unknown
Last updated
2021-01-05

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

Conditions

Sudden deafness

Interventions

Group A:Batroxobin + methylprednisolone intravenous injection
Group B:Methylprednisolone intravenous injection + dexamethasone injection
Group C:Batroxobin + methylprednisolone intravenous injection + dexamethasone tympanic injection

Sponsors

The First Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Comply with the diagnostic criteria in the U.S. "Guidelines for the Diagnosis and Treatment of Sudden Deafness (2019)"; 2. Age over 18 years old, regardless of gender; 3. Onset of one ear; 4. Onset within 2 weeks, first diagnosis and treatment and hospitalization; 5. Obtained Written informed consent was obtained.

Exclusion criteria

Exclusion criteria: 1. History of middle ear and inner ear surgery; congenital deafness, conductive deafness, presbycusis, explosive deafness, drug-induced deafness, large vestibular aqueduct syndrome, Meniere's disease, Deafness accompanied by systemic genetic diseases, space-occupying diseases of the cochlea and cerebellopontine angle, and sudden deafness caused by traumatic lymphatic atrophy, syphilis infection, cerebrovascular accident, etc.; 2. Children, pregnant and lactating women , Those who are allergic or contraindicated to the study drugs (such as active ulcers, mental disorders, epilepsy, tuberculosis, adrenal hyperfunction, etc.); 3. have serious systemic diseases (such as severe hypertension, diabetes due to There are hormone contraindications, so it is ruled out), language barriers, and those who cannot complete the treatment according to the pre-designed clinical trial protocol.

Design outcomes

Primary

MeasureTime frame
Pure tone listening;Tinnitus symptoms;Ear stuffy symptoms;Vertigo symptoms;

Countries

China

Contacts

Public ContactXiaowen Zhang

The First Affiliated Hospital of Guangzhou Medical University

735104799@qq.com+86 13503018465

Outcome results

None listed

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