UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023509 |
|---|---|
| Receipt number | 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 17:47:54 |
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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
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
chihiro@inm.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027079
| 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 |
