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Intratympanic steroid for Bell's palsy. Single-centre randomized controlled trial.

Intratympanic steroid for Bell's palsy. Single-centre randomized controlled trial. - Intratympanic steroid for Bell's palsy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000024313
Enrollment
108
Registered
2016-10-07
Start date
2016-11-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Bell&#39

Interventions

Control group: Conventional treatment (60 mg/day for 5 days, then taper) and anti-viral drug (Valacyclovir 3000mg/day for 5days) Intervention group: Intratympanic steroid (0.5 ml Dexamethasone once

Sponsors

Kurashiki Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Within 1 weeks after disease onset Severe facial palsy (Yanagihara facial grade 12 or less)

Exclusion criteria

Exclusion criteria: Pregnancy, breast-Feeding. dementia and difficult to enroll trial.

Design outcomes

Primary

MeasureTime frame
Non-recovery rate(House-Brackmann grade 3 or more) at 6 month after disease onset. We define recovery as House-Brackmann grade 1-2. Primary outcome will be measured by blinded assesser.—

Secondary

MeasureTime frame
Non-recovery rate at last follow up (6 to 12 month after disease onset) Tympanic membrane perforation and any complications during intratympanic injection (e.g. vertigo, vomiting, and vasovagal syncope)—

Countries

Japan

Contacts

Public ContactYuki Nyuko

Clinical Research Center Kurashiki Central Hospital Clinical Research Center Kurashiki Central Hospital

tf14817@kchnet.or.jp086-422-0210

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026