UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041042 |
|---|---|
| Receipt number | R000046869 |
| Scientific Title | Double-blind randomized controlled trial to examine the effects of a highly absorbable curcumin oral agent on lymphocyte type and count in the elderly |
| Date of disclosure of the study information | 2020/07/09 |
| Last modified on | 2021/12/16 10:55:48 |
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Basic information
Public title
A trial to examine the effects of Curcu-Rouge on immunity in the elderly
Acronym
Curcu-Rouge and Immunity in the elderly
Scientific Title
Double-blind randomized controlled trial to examine the effects of a highly absorbable curcumin oral agent on lymphocyte type and count in the elderly
Scientific Title:Acronym
Highly absorbable curcumin and lymphocyte types in the elderly
Region
| Japan |
Condition
Condition
Elderly
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of the newly developed highly absorbable curcumin oral agent on lymphocyte type and count in the elderly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II,III
Assessment
Primary outcomes
Lymphocyte type and count (T cell count, CD4T cell count and CD8T cell cunt ratio, regulatory T cell count, naive T cell count and memory T cell count ratio, total CD28T cell count among CD8T cells, B cell count, NK cell count, and T cell proliferation coefficient)
Key secondary outcomes
LOX-index
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
Placebo food not containing curcumin
Interventions/Control_2
Highly absorbable curcumin: curcu-rouge
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Main Inclusion Criteria
Elderly persons (aged 60 years or older, regardless of sex) will be recruited through posters or websites, and persons from the general population who have freely given consent in writing will be enrolled as subjects of the study.
In addition, if a person who is taking an oral medication due to a lifestyle-related disease applies, enrollment will be possible after confirmation that s/he is active and stable.
Definition of activity: ECOG performance status (PS): 0 or 1
Definition of stable state:
(i) There is no change in the content and amount of oral medication within the 6-month period before the consent date
(ii) No history of hospitalization within the 1-year period before the consent date
Key exclusion criteria
Persons who fall under any of the following criteria will be excluded from the study.
1) Persons who regularly consume health foods containing curcumin
2) Persons who have a history of allergy to curcumin
3) Persons who are pregnant or breastfeeding
4) Persons who undergoing treatment for malignant tumor
5) Persons who regularly take an antibiotic or steroid
6) Persons who are taking two or more antiplatelet agents or a single antiplatelet agent with another antithrombotic agent (e.g., anticoagulant, EPA agent, prostacyclin agent)
7) Persons who have a history of cerebral hemorrhage and are taking a single antiplatelet agent
8) Persons undergoing home oxygen therapy
9) Persons undergoing dialysis due to renal failure
10) Persons with severe liver dysfunction/cirrhosis
11) Persons with severe cardiac dysfunction (left ventricular ejection fraction less than 20%)
12) In addition, persons for whom the research director or co-researcherinvestigators determine to be inappropriate for participation in this research
Target sample size
40
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
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
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
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 | 07 | 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
Main results already published
Date of protocol fixation
| 2020 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 18 | Day |
Date of closure to data entry
| 2020 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 10 | Month | 12 | Day |
Date analysis concluded
| 2021 | Year | 02 | Month | 12 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 09 | 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=R000046869
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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