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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000024313 |
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Date of registration:
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07/10/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Intratympanic steroid for Bell's palsy. Single-centre randomized controlled trial.
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Scientific title:
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Intratympanic steroid for Bell's palsy. Single-centre randomized controlled trial. - Intratympanic steroid for Bell's palsy |
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Date of first enrolment:
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2016/11/01 |
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Target sample size:
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108 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027879 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Takashi
Fujiwara |
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Address:
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1-1-1 Miwa, Kurashiki City, Okayama Prefecture
Japan |
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Telephone:
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086-422-0210 |
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Email:
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t.fujiwarabi@gmail.com |
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Affiliation:
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Kurashiki Central Hospital Otolaryngology |
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Name:
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Yuki
Nyuko |
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Address:
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1-1-1 Miwa, Kurashiki City, Okayama Prefecture
710-8602
Japan |
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Telephone:
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086-422-0210 |
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Email:
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tf14817@kchnet.or.jp |
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Affiliation:
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Clinical Research Center Kurashiki Central Hospital Clinical Research Center Kurashiki Central Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: Pregnancy, breast-Feeding. dementia and difficult to enroll trial.
Age minimum:
20years-old
Age maximum:
200years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Bell's palsy
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Intervention(s)
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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
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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)
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Source(s) of Monetary Support
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No funding
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Ethics review
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Status: YES
Approval date: 19/10/2016
Contact:
tf14817@kchnet.or.jp
IRB of Kurashiki Central Hospital
+81-86-422-0210
tf14817@kchnet.or.jp
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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08/09/2018 |
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URL:
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