UMIN-CTR Clinical Trial

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
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 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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046869