UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001441 |
|---|---|
| Receipt number | R000001748 |
| Scientific Title | The effect of Formula glycyrrhizae atractyloidis cinnamomi hoelen on the sudden deafness |
| Date of disclosure of the study information | 2009/06/30 |
| Last modified on | 2010/07/27 17:33:15 |
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Basic information
Public title
The effect of Formula glycyrrhizae atractyloidis cinnamomi hoelen on the sudden deafness
Acronym
The effect of Formula glycyrrhizae atractyloidis cinnamomi hoelen on the sudden deafness
Scientific Title
The effect of Formula glycyrrhizae atractyloidis cinnamomi hoelen on the sudden deafness
Scientific Title:Acronym
The effect of Formula glycyrrhizae atractyloidis cinnamomi hoelen on the sudden deafness
Region
| Japan |
Condition
Condition
Sudden deafness
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of Formula glycyrrhizae atractylodis cinnamomi hoelen on the chronic hearing impairment induced by the sudden deafness.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
audiometry data
Key secondary outcomes
speach test, DPOAE, serum K
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treated group takes the traditional Chinese medicine 12 weeks and observed 16 weeks.
Interventions/Control_2
The control group is observed 16 weeks without taking hebal formula.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Diagnosed as sudden deafness according to ICD 10.
At least three months has passed after onset.
Serum K level is within the normal limit.
Out clinic patient.
Key exclusion criteria
Having other diseases that will influence to the audiomtry.
Taking steroids.
Can not visit the out clinic.
Can not understand about study.
Can not take the herbal medicine.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuo Yaegashi |
Organization
Tohoku University
Division name
Center for Asian Traditional Medicine
Zip code
Address
1-1 Seiryo-cho, Aoba Ward, Sendai City Miyagi Japan
TEL
022-717-7185
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koh Iwasaki |
Organization
Tohoku University
Division name
Center for traditional Asian medicine
Zip code
Address
1-1 Seiryo-cho, Aoba Ward, Sendai City Miyagi Japan
TEL
022-717-7185
Homepage URL
QFG03604@nifty.com
Sponsor or person
Institute
Center for traditional Asian medicine, tohoku University
Institute
Department
Personal name
Funding Source
Organization
Center for traditional Asian medicine, tohoku University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Division of Otolaryngology, Tohoku University hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 06 | Month | 30 | 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
No significancy had been prooved.
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
Completed
Date of protocol fixation
| 2008 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 10 | Month | 20 | Day |
Last modified on
| 2010 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001748
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
