UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022223 |
|---|---|
| Receipt number | R000025590 |
| Scientific Title | Study of safety and usefulness of Java ginger Bangle against the cognitive decline in the elderly (Phase 2 clinical trial as a food) |
| Date of disclosure of the study information | 2016/05/09 |
| Last modified on | 2021/05/06 15:23:44 |
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Basic information
Public title
Study of safety and usefulness of Java ginger Bangle against the cognitive decline in the elderly
(Phase 2 clinical trial as a food)
Acronym
Safety and usefulness of Bangle against connitive decline
Scientific Title
Study of safety and usefulness of Java ginger Bangle against the cognitive decline in the elderly
(Phase 2 clinical trial as a food)
Scientific Title:Acronym
Safety and usefulness of Bangle against connitive decline
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and efficacy of Java ginger Bangle for the mild cognitive impairment of the age-related progression
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MMSE
Key secondary outcomes
Trail Making
MENFIS
Barthel Index
NPI-Q
Adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Food containing Bangle, 1 per serving
(48weeks)
Interventions/Control_2
Food not containing Bangle, 1 per serving
(48weeks)
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
| 60 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)males and females aged 60 to 80 years old.
2)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
1)Subject suffering from a malignant tumor
2)Subject suffering from diseases that are severe heart disease, liver disease, blood disease, lung disease and disease that affects life
3)Subject that oral administration is not possible
4)Subject that research attendingt physician determines inappropriate
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiko Miyamura |
Organization
Kochi Medical school Hospital
Division name
Pharmacy
Zip code
Address
Kohasu, Oko-cho, Nankoku-shi, Kochi
TEL
088-880-2549
jm-kouheij@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kohei Jobu |
Organization
Kochi Medical school Hospital
Division name
Pharmacy
Zip code
Address
Kohasu, Oko-cho, Nankoku-shi, Kochi
TEL
088-880-2549
Homepage URL
jm-kouheij@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical school Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 09 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 06 | Day |
Last modified on
| 2021 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025590
