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A randomized, open, parallel-controlled, multicenter trial of alprostadil injection in the treatment of sudden hearing loss

A randomized, open, parallel-controlled, multicenter trial of alprostadil injection in the treatment of sudden hearing loss

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064323
Enrollment
Unknown
Registered
2022-10-02
Start date
2022-10-01
Completion date
Unknown
Last updated
2023-09-26

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

Conditions

Sudden hearing loss

Interventions

experimental group:routine treatment of sudden hearing loss combined with alprostadil injection
Control group:routine treatment of sudden hearing loss

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years old, gender not limited; 2. Meet the diagnostic criteria of total frequency decline type and total deafness type of sudden hearing loss; 3. Patients with onset within 2 weeks and not treated with alprostadil; 4. Patients voluntarily participate in this trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant, perinatal, and lactating women; 2. Those who are allergic to prostaglandin E; 3. Lesions such as middle ear lesions, Meniere's disease, auditory neuroma, and large vestibular aqueduct syndrome; 4. Serious systemic diseases such as tumors, serious infections, cerebrovascular accidents, uremia, connective tissue disease, and acute stress; 5. Cognitive impairments such as psychiatric disorders that affect compliance; 6. Those with poor adherence to the protocol as judged by the investigator; 7. Patients with other factors that the investigator does not consider eligible for inclusion in the trial.

Design outcomes

Primary

MeasureTime frame
Hearing tests;

Secondary

MeasureTime frame
vestibular function tests;

Countries

China

Contacts

Public ContactQiuju Wang

Chinese PLA General Hospital

wqcr301@vip.sina.com+86 10 5549 9143

Outcome results

None listed

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