UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025128 |
|---|---|
| Receipt number | R000028894 |
| Scientific Title | Comparison of benefits of high-dose steroid Administration and normal-dose Steroid in combination with antiviral agentsin in the Treatment of Bell's Palsy |
| Date of disclosure of the study information | 2016/12/04 |
| Last modified on | 2020/12/05 10:11:21 |
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Basic information
Public title
Comparison of benefits of high-dose steroid Administration and normal-dose Steroid in combination with antiviral agentsin in the Treatment of Bell's Palsy
Acronym
Comparison of benefits of treatments in the Treatment of Bell's Palsy
Scientific Title
Comparison of benefits of high-dose steroid Administration and normal-dose Steroid in combination with antiviral agentsin in the Treatment of Bell's Palsy
Scientific Title:Acronym
Comparison of benefits of treatments in the Treatment of Bell's Palsy
Region
| Japan |
Condition
Condition
Bell's Palsy
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prospective randomized controlled multicenter studies are clearly needed to clarify the best treatment of Bell's palsy. Our focus of investigation is on the effectiveness of normal PSL therapy in combination with antiviral agent therapy and high-dose PSL therapy alone.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The patients are divided into two groups based on the treatment protocols with:Group 1 receiving a high dose of PSL at 200 mg/day + Hespander + Mannitol intravenously; Group 2 receiving a normal dose of PSL at 60 mg/day orally + the antiviral agent VACV at 3000 mg/day.
We assess complete recovery as an HB grade of grade I at 1 year.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
One group receives a high dose of PSL at 200 mg/day + Hespander + Mannitol intravenously.
Interventions/Control_2
Another group receives a normal dose of PSL at 60 mg/day orally + the antiviral agent + FCV 1500mg/day.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.within 7 days of the onset of the disease
2.an HB grade of V or VI
3.follow-up can be performed until complete recovery from facial paralysis or 12 months from onset of the disease
4.informed consent has been obtained
Key exclusion criteria
1.recurrent palsy
2.auricular redness or strong otalgia
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Kakehata |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Otolaryngology, Head and Neck Surgery
Zip code
990-9585
Address
2-2-2 Iida-Nishi, Yamagata 990-9585, Japan
TEL
023-628-5380
seijik06@gmail.com
Public contact
Name of contact person
| 1st name | Takatoshi |
| Middle name | |
| Last name | Furukawa |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Otolaryngology, Head and Neck Surgery
Zip code
9909585
Address
2-2-2 Iida-Nishi, Yamagata 990-9585, Japan
TEL
023-628-5380
Homepage URL
t-furukawa@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Department of Otolaryngology, Head and Neck Surgery, Yamagata University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tohoku University School of medicine
Tohoku Medical and Pharmaceutical University
Kurashiki central hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamagata University Faculty of Medicine
Address
2-2-2 Iida-Nishi, Yamagata 990-9585, Japan
Tel
0236285017
t-furukawa@med.id.yamagata-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
山形大学医学部耳鼻咽喉科学講座(山形県)
東北大学医学部耳鼻咽喉科学講座(宮城県)
東北医科薬科大学医学部耳鼻咽喉科学講座(宮城県)
倉敷中央病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 02 | Day |
Last modified on
| 2020 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028894
