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Recruitment status Completed
Unique ID issued by UMIN UMIN000011247
Receipt No. R000013177
Scientific Title The clinical evaluation of the Kampo therapy for Meniere disease.
Date of disclosure of the study information 2013/09/01
Last modified on 2017/07/25

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Basic information
Public title The clinical evaluation of the Kampo therapy for Meniere disease.
Acronym The Kampo therapy for Meniere disease.
Scientific Title The clinical evaluation of the Kampo therapy for Meniere disease.
Scientific Title:Acronym The Kampo therapy for Meniere disease.
Region
Japan

Condition
Condition meniere disease
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical efficacy of Kampo medicine for meniere disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Pure-tone audiometry,The frequency of vertigo,Visual analogue scale
Key secondary outcomes Clinical stratification of meniere disease,Short increment sensitivity index test,Test for gaze and positional nystagmus,caloric test,Dizziness handicap inventory,MOS Short- Form 36-Item Health Survey

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Isosorbide 60ml-90ml, Adenosine triphosphate disodium hydrate 3g, Mecobalamin 1.5mg
Interventions/Control_2 Adenosine triphosphate disodium hydrate 3g, Mecobalamin 1.5mg, Kampo medicine
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Definite meniere disesase, Atypical meniere disease(cochlear type)
Key exclusion criteria Atypical meniere disease(vestibular type)
The patient who has been treated with modern or kampo medicine within a month for meniere disease.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Ishige
Organization Oriental Medicine Reserch Center
Division name Division of Kampo medicine
Zip code
Address 5-9-1 Shirokane Minatoku
TEL 03-3444-6161
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Ishige
Organization Oriental Medicine Reserch Center
Division name Division of Kampo medicine
Zip code
Address 5-9-1 Shirokane Minatoku Tokyo
TEL 03-3444-6161
Homepage URL
Email

Sponsor
Institute Oriental Medicine Reserch Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Asakadai Central 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 朝霞台中央病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2013 Year 09 Month 01 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 Completed
Date of protocol fixation
2013 Year 08 Month 05 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 07 Month 22 Day
Last modified on
2017 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013177


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