UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the efficacy and safety of Java ginger(Bangle, Zingiber purpureum) against cognitive decline in the elderly
Title of the study (Brief title)	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	Mitsuhiko Miyamura
Organization	Kochi Medical School Hospital
Division name	Pharmacy
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	Junko Yokota
Organization	Kochi Medical School Hospital
Division name	Pharmacy
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 09 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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