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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029027
Receipt No. R000033129
Scientific Title Study of the efficacy and safety of Java ginger(Bangle, Zingiber purpureum) against cognitive decline in the elderly
Date of disclosure of the study information 2017/09/11
Last modified on 2017/09/01

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Basic information
Public title Study of the efficacy and safety of Java ginger(Bangle, Zingiber purpureum) against cognitive decline in the elderly
Acronym Study of the efficacy and safety of Java ginger(Bangle, Zingiber purpureum) against cognitive decline in the elderly
Scientific Title Study of the efficacy and safety of Java ginger(Bangle, Zingiber purpureum) against cognitive decline in the elderly
Scientific Title:Acronym Study of the efficacy and safety of Java ginger(Bangle, Zingiber purpureum) against cognitive decline in the elderly
Region
Japan

Condition
Condition Mild Cognitive Impairment
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Elderly people with dementia and mild cognitive impairment are increasing and are expected to increase in the future.
Therefore, prevention of progression from MCI to dementia and establishment of MCI's preventive method are desired, but correspondence is not sufficient.
Therefore, we aim for the development of food that suppresses decline in cognitive function and examine the effectiveness and safety of Java ginger for the deterioration of cognitive function of the elderly.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes 1.Congnitive function(12weeks, 24weeks)
MMSE(Mini-mental State Examination)
MENFIS(Mental Function Impairment Scale)
2.MRI(24weeks)
Key secondary outcomes 1.Effectiveness(12 weeks, 24 weeks)
a:Caution function: Trail Making Test
b:Daily living behavior (ADL): Barthel Index
c:Measurable daily living activities (IADL) scale
d:Behavioral disorders associated with dementia, Mental symptoms (BPSD): NPI-Q (Neuropsychiatric Inventory)
e:Care burden: Zarit nursing care burden scale
2.Safety
a:blood biochemical test(12 weeks, 24 weeks)
b:Drink Record(everyday)

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 NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Examination period: 24 weeks from the consent acquisition, 24 weeks observation period after the end of the dose, for a total of 48 weeks
Test food: 3 tablets twice daily (tablets containing 85 mg of Java ginger extract per tablet)
Evaluation timing: Prior to administration, 12 weeks after administration, 24 weeks, 48 weeks
Interventions/Control_2 Test food(placebo): 3 tablets twice daily
Evaluation timing: Prior to administration, 12 weeks after administration, 24 weeks, 48 weeks
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

Not applicable
Gender Male and Female
Key inclusion criteria Subjects were those who were diagnosed with mild cognitive impairment (MCI) among those who received Dementia-Related Disease Medical Center in the Kochi Medical School Hospital.
Key exclusion criteria 1. Persons suffering from dementia
2. Serious heart disease, liver disease, kidney disease, blood disease, lung disease, and those suffering from diseases judged to affect life
3. Persons who can not orally administer
4. Others who are deemed inappropriate by the research doctor
Target sample size 20

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, 7838505, Japan
TEL 088-880-2549
Email im55@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junko Yokota
Organization Kochi Medical School Hospital
Division name Pharmacy
Zip code
Address Kohasu, Oko-cho, Nankoku-shi, Kochi, 7838505, Japan
TEL 088-880-2549
Homepage URL
Email jm-yokotaj@kochi-u.ac.jp

Sponsor
Institute Kochi Medical School Hospital
Institute
Department

Funding Source
Organization HOSODA SHC CO.LTD.
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 11 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 Preinitiation
Date of protocol fixation
2017 Year 09 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 10 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
2017 Year 09 Month 06 Day
Last modified on
2017 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033129

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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