Unique ID issued by UMIN | UMIN000024313 |
---|---|
Receipt number | R000027879 |
Scientific Title | Intratympanic steroid for Bell's palsy. Single-centre randomized controlled trial. |
Date of disclosure of the study information | 2016/10/07 |
Last modified on | 2020/01/10 16:16:47 |
Intratympanic steroid for Bell's palsy. Single-centre randomized controlled trial.
Intratympanic steroid for Bell's palsy
Intratympanic steroid for Bell's palsy. Single-centre randomized controlled trial.
Intratympanic steroid for Bell's palsy
Japan |
Bell's palsy
Oto-rhino-laryngology |
Others
NO
To assess intratypmanic steroid injection for Bell's palsy
Safety,Efficacy
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.
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)
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
No treatment
NO
NO
Institution is not considered as adjustment factor.
Numbered container method
2
Treatment
Medicine |
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 or twice per week for 2weeks) add to conventional treatment
20 | years-old | <= |
200 | years-old | > |
Male and Female
Within 1 weeks after disease onset
Severe facial palsy (Yanagihara facial grade 12 or less)
Pregnancy, breast-Feeding.
dementia and difficult to enroll trial.
108
1st name | Takashi |
Middle name | |
Last name | Fujiwara |
Kurashiki Central Hospital
Otolaryngology
710-8602
1-1-1 Miwa, Kurashiki City, Okayama Prefecture
086-422-0210
t.fujiwarabi@gmail.com
1st name | Yuki |
Middle name | |
Last name | Nyuko |
Clinical Research Center Kurashiki Central Hospital
Clinical Research Center Kurashiki Central Hospital
710-8602
1-1-1 Miwa, Kurashiki City, Okayama Prefecture
086-422-0210
tf14817@kchnet.or.jp
Kurashiki Central Hospital
No funding
Self funding
IRB of Kurashiki Central Hospital
Miwa 1-1-1, Kurashiki City, Okayama, Japan
+81-86-422-0210
tf14817@kchnet.or.jp
NO
倉敷中央病院
2016 | Year | 10 | Month | 07 | Day |
Unpublished
Completed
2016 | Year | 08 | Month | 17 | Day |
2016 | Year | 10 | Month | 19 | Day |
2016 | Year | 11 | Month | 01 | Day |
2018 | Year | 09 | Month | 08 | Day |
2018 | Year | 12 | Month | 31 | Day |
2018 | Year | 12 | Month | 31 | Day |
2018 | Year | 12 | Month | 31 | Day |
2016 | Year | 10 | Month | 06 | Day |
2020 | Year | 01 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027879