UMIN-CTR Clinical Trial

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

Mild Cognitive Impairment

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

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

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

Institute

Kochi Medical School Hospital

Institute

Department

Personal name

Organization

HOSODA SHC CO.LTD.

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

09

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

09

Month

06

Day

Last modified on

2017

Year

09

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033129