UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042471
Receipt number R000048445
Scientific Title Evaluation of the efficacy of high-absorption curcumin capsules (CurcuRouge) via an oral route on cognitive function index: A double-blind, randomized controlled trial
Date of disclosure of the study information 2020/11/18
Last modified on 2021/12/16 10:30:48

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Basic information

Public title

A double-blind, randomized controlled trial examining the effect of curcumin on cognitive function

Acronym

Studies examining the effects of curcumin on cognitive function

Scientific Title

Evaluation of the efficacy of high-absorption curcumin capsules (CurcuRouge) via an oral route on cognitive function index: A double-blind, randomized controlled trial

Scientific Title:Acronym

A double-blind, randomized controlled trial examining the effect of curcumin on cognitive function

Region

Japan


Condition

Condition

Mild cognitive impairment

Classification by specialty

Medicine in general Geriatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of a newly developed high-absorption curcumin product (brand name: CurcuRouge) administered via an oral route on the general public suspected of having MCI without dementia using MMSE-J (a questionnaire for cognitive function test conducted by an interviewer) scores.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To evaluate the efficacy of a newly developed high-absorption curcumin product (brand name: CurcuRouge) administered via an oral route on the general public suspected of having MCI without dementia using MMSE-J (a questionnaire for cognitive function test conducted by an interviewer) scores.

Key secondary outcomes



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

Treatment

Type of intervention

Food

Interventions/Control_1

Placebo food not containing curcumin.
Take 90 mg of 1 capsule at a time, 1 capsule twice a day.
Treatment duration will be 24 weeks.

Interventions/Control_2

Highly absorbable curcumin.
Take 90 mg of 1 capsule at a time, 1 capsule twice a day.
Treatment duration will be 24 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

50 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Main selection criteria
"People who are worried about forgetting things" will be recruited through posters or websites, and MMSE-J and SDS (Self-rating depression scale) interview tests will be conducted.
(1) MMSE-J: 24 points or more, 27 points or less (mild cognitive impairment suspected)
(2) Depression screening test SDS: 23 points or more, 47 points or less (normal range)
(3) Age 50 and over, regardless of gender.
(4) Obtain document consent by the person's free will

If a person who is taking an oral medication other than dementia, such as a lifestyle-related disease, applies, it is possible to register after confirming that the patient is active and the condition is stable.
Definition of activity: ECOG PS (Performance Status): 0 or 1
Definition of state stable:
(iii) No change in the content and amount of oral medication for 6 months before the consent date
(iv) No history of hospitalization within 1 year before the date of consent

Key exclusion criteria

Exclusion criteria
Participants who conform to any of the following categories will be excluded from the present study.
1)Participants regularly consuming other curcumin containing health food products
2)Participants with a history of curcumin allergy
3)Participants who are pregnant or breastfeeding
4)Participants receiving medication and outpatient care for dementia
5)Participants receiving chemotherapy for a malignant tumor
6)Participants with regular use of antibiotics or steroids
7)Participants receiving two or more antiplatelet agents, or one antiplatelet agent and another antithrombotic agent (e.g., anticoagulant, EPA agent, prostacyclin agent)
8)Participants with a history of cerebral hemorrhage and taking an antiplatelet drug
9)Participants receiving oxygen therapy at home
10)Participants who have renal failure and are receiving dialysis
11)Participants with severe liver dysfunction or cirrhosis
12)Participants with severe cardiac dysfunction
13)Participants deemed inappropriate for participation in the study by the principal investigator and the sub-investigators.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Koji
Middle name
Last name Hasegawa

Organization

National Hospital Organization Kyoto Medical Center

Division name

Division of Translational Research

Zip code

612-8555

Address

1-1 Mukaihatacho Fukakusa Fushimi-ku, Kyoto

TEL

075-641-9161

Email

koj@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Koji
Middle name
Last name Hasegawa

Organization

National Hospital Organization Kyoto Medical Center

Division name

Division of Translational Research

Zip code

612-8555

Address

1-1 Mukaihatacho Fukakusa Fushimi-ku, Kyoto

TEL

075-641-9161

Homepage URL


Email

koj@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

National Hospital Organization Kyoto Medical Center

Institute

Department

Personal name



Funding Source

Organization

Therabio-pharma

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethical Committee, National Hospital Organization Kyoto Medical Center

Address

1-1 Mukaihatacho Fukakusa Fushimi-ku

Tel

075-641-9161

Email

ayasoda@kuhp.kyoto-u.ac.jp


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

2020 Year 11 Month 18 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

Enrolling by invitation

Date of protocol fixation

2020 Year 03 Month 23 Day

Date of IRB

2020 Year 04 Month 21 Day

Anticipated trial start date

2020 Year 11 Month 18 Day

Last follow-up date

2022 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 11 Month 16 Day

Last modified on

2021 Year 12 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048445


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name