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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001441
Receipt No. 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

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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
Email

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
Email QFG03604@nifty.com

Sponsor
Institute Center for traditional Asian medicine, tohoku University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001748

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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