UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The clinical evaluation of the Kampo therapy for Meniere disease.
Title of the study (Brief title)	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

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

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	Tatsuya Ishige
Organization	Oriental Medicine Reserch Center
Division name	Division of Kampo medicine
Address	5-9-1 Shirokane Minatoku
TEL	03-3444-6161
Email

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

Sponsor
Institute	Oriental Medicine Reserch Center
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000013177