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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042471
Receipt No. 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 2020/11/16

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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
Institute National Hospital Organization Kyoto Medical Center
Institute
Department

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 Preinitiation
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
2020 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.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


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