UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041891 |
|---|---|
| Receipt number | R000047815 |
| Scientific Title | Confirmation study of immunostimulation effects by test-food intake |
| Date of disclosure of the study information | 2021/09/29 |
| Last modified on | 2021/09/14 22:52:47 |
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Basic information
Public title
Confirmation study of immunostimulation effects by test-food intake
Acronym
Confirmation study of immunostimulation effects by test-food intake
Scientific Title
Confirmation study of immunostimulation effects by test-food intake
Scientific Title:Acronym
Confirmation study of immunostimulation effects by test-food intake
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to discuss some kind of immunostimulation effect by test-food intakes for 6 weeks
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Variations in influenza-antibody titer
Key secondary outcomes
1. High sensitive IL-4
2. High sensitive IFN-gamma
3. NK cell activity
4. Secretary IgA in saliva
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
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Continuous consumption of
the RHAMNOX (200 mg)-containing test-food capsule to the volunteers, once a day (after breakfast) for 6 weeks.
Interventions/Control_2
Continuous consumption of
the RHAMNOX (100 mg)-containing test-food capsule to the volunteers, once a day (after breakfast) for 6 weeks.
Interventions/Control_3
Continuous consumption of
the placebo-food capsule to the volunteers, once a day (after breakfast) for 6 weeks.
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
(1) Healthy male/female volunteers of not less than 50 years old.
(2) Volunteers who gave informed consent to take part in this trial after being provided with an explanation of the protocol detail.
Key exclusion criteria
(1) Volunteers with influenza-virus infection within a year before giving informed consent to take part in this trial.
(2) Volunteers with influenza vaccination recently at the point of giving informed consent to take part in this trial.
(3) Volunteers with previous history of some kind of symptom just like anaphylactic shock, which was caused by influenza vaccination.
(4) Volunteers taking steadily in the medicine, which might affect the test results.
(5) All through this trial, volunteers who have any difficulty in refraining from taking steadily in the health-specific/functional/health foods, which might affect the test results.
(6) Pregnant, possibly pregnant, or lactating women.
(7) Volunteers with present/previous medical history of serious diseases in heart, liver, kidney and/or digestive organs.
(8) Volunteers with excessive alcohol intake.
(9) Volunteers with heavy smoking.
(10) Volunteers with extremely irregular life rhythms, midnight work and/or irregular shift one.
(11) Volunteers with drug and/or food allergy.
(12) Volunteers who are now under the other clinical tests with some kind of medicines/foods, or took part in those tests within four weeks after this trial.
(13) Volunteers who donated over 200 mL of their whole blood and/or blood components within a month into this trial.
(14) Males who donated over 400 mL of their whole blood within the last three months into this trial.
(15) Females who donated over 400 mL of their whole blood within the last four months into this trial.
(16) Males who will be collected over 1200 mL in total of their blood within the last twelve months, after adding the planned sampling blood amounts in this trial.
(17) Females who will be collected over 800 mL in total of their blood within the last twelve months, after adding the planned sampling blood amounts in this trial.
(18) Others who have been determined as ineligible for participation, according to the principal/sub investigator's opinions.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Terasawa |
Organization
KONAN CHEMICAL MANUFACTURING Co Ltd.
Division name
Acting Manager
Zip code
510-0103
Address
1515 Kusu-Cho-Kita-Gomizuka, Yokkaichi-shi, Mie 510-0103, Japan
TEL
059-397-2612
info@konanchemical.co.jp
Public contact
Name of contact person
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Fujimoto |
Organization
CPCC Company Limited
Division name
Planning & Sales Department
Zip code
101-0047
Address
4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
KONAN CHEMICAL MANUFACTURING Co Ltd.
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.co.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
| 2021 | Year | 09 | Month | 29 | 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
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 08 | 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 | 09 | Month | 24 | Day |
Last modified on
| 2021 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047815
