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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023509
Receipt No. R000027079
Scientific Title Effects of Kihito on cognitive functions in Alzheimer's disease patients
Date of disclosure of the study information 2016/08/22
Last modified on 2018/09/18

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Basic information
Public title Effects of Kihito on cognitive functions in Alzheimer's disease patients
Acronym Effects of Kihito on cognitive functions in Alzheimer's disease patients
Scientific Title Effects of Kihito on cognitive functions in Alzheimer's disease patients
Scientific Title:Acronym Effects of Kihito on cognitive functions in Alzheimer's disease patients
Region
Japan

Condition
Condition Alzheimer's disease
Classification by specialty
Neurology Psychosomatic Internal Medicine Geriatrics
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation of cognitive functions at pre and post (16 weeks after) administration of Kampo medicine, Kihito.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes At the pre and post (for 16 weeks) administration of kKihito, these tests of cognitive functions are done; Mini Mental State Examination (MMSE)and Repeatable Battery for the Assessment (RBANS).
Key secondary outcomes analysis of the blood

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Only Cholinesterase inhibitor (aricept, for 16 weeks - Cholinesterase inhibitor plus Kihito for 16 weeks
*without washout period
*Tsumura Kihito (2.5 g in package; 3 packages/day)
Interventions/Control_2 Cholinesterase inhibitor plus Kihito for 16 weeks - Only Cholinesterase inhibitor (aricept, for 16 weeks
*without washout period
*Tsumura Kihito (2.5 g in package; 3 packages/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
20 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Adults living in Toyama prefecture, who was diagnosed as Alzheimer's disease by cognitive testa and image analyses, and has taken any cholinesterase inhibitor more than 6 months. Score of MMSE in the person is above 15 points.
Key exclusion criteria Persons whose MMSE score is below 14 points.
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chihiro Tohda
Organization University of Toyama
Division name Division of Neuromedical Science, Institute of Natural Medicine
Zip code
Address 2630 Sugitani, Toyama, 930-0194, JAPAN
TEL 076-434-7646
Email chihiro@inm.u-toyama.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chihiro Tohda
Organization University of Toyama
Division name Division of Neuromedical Science, Institute of Natural Medicine
Zip code
Address 2630 Sugitani, Toyama, 930-0194, JAPAN
TEL 076-434-7646
Homepage URL
Email chihiro@inm.u-toyama.ac.jp

Sponsor
Institute University of Toyama
Institute
Department

Funding Source
Organization University of Toyama
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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 国立大学法人 富山大学

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 22 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
2016 Year 03 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 22 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 09 Month 30 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 05 Day
Last modified on
2018 Year 09 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027079

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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