UMIN-CTR Clinical Trial

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
Email	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
Email	jm-kouheij@kochi-u.ac.jp

Sponsor
Institute	Kochi Medical school Hospital
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025590