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 |
A double-blind, randomized controlled trial examining the effect of curcumin on cognitive function
Studies examining the effects of curcumin on cognitive function
Evaluation of the efficacy of high-absorption curcumin capsules (CurcuRouge) via an oral route on cognitive function index: A double-blind, randomized controlled trial
A double-blind, randomized controlled trial examining the effect of curcumin on cognitive function
Japan |
Mild cognitive impairment
Medicine in general | Geriatrics |
Others
NO
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.
Safety
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.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
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.
Highly absorbable curcumin.
Take 90 mg of 1 capsule at a time, 1 capsule twice a day.
Treatment duration will be 24 weeks.
50 | years-old | <= |
Not applicable |
Male and Female
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
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.
60
1st name | Koji |
Middle name | |
Last name | Hasegawa |
National Hospital Organization Kyoto Medical Center
Division of Translational Research
612-8555
1-1 Mukaihatacho Fukakusa Fushimi-ku, Kyoto
075-641-9161
koj@kuhp.kyoto-u.ac.jp
1st name | Koji |
Middle name | |
Last name | Hasegawa |
National Hospital Organization Kyoto Medical Center
Division of Translational Research
612-8555
1-1 Mukaihatacho Fukakusa Fushimi-ku, Kyoto
075-641-9161
koj@kuhp.kyoto-u.ac.jp
National Hospital Organization Kyoto Medical Center
Therabio-pharma
Profit organization
Ethical Committee, National Hospital Organization Kyoto Medical Center
1-1 Mukaihatacho Fukakusa Fushimi-ku
075-641-9161
ayasoda@kuhp.kyoto-u.ac.jp
NO
2020 | Year | 11 | Month | 18 | Day |
Unpublished
Enrolling by invitation
2020 | Year | 03 | Month | 23 | Day |
2020 | Year | 04 | Month | 21 | Day |
2020 | Year | 11 | Month | 18 | Day |
2022 | Year | 04 | Month | 30 | Day |
2020 | Year | 11 | Month | 16 | Day |
2021 | Year | 12 | Month | 16 | Day |
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 |