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 |
Confirmation study of immunostimulation effects by test-food intake
Confirmation study of immunostimulation effects by test-food intake
Confirmation study of immunostimulation effects by test-food intake
Confirmation study of immunostimulation effects by test-food intake
Japan |
Healthy male/female adults
Adult |
Others
NO
In order to discuss some kind of immunostimulation effect by test-food intakes for 6 weeks
Safety,Efficacy
Variations in influenza-antibody titer
1. High sensitive IL-4
2. High sensitive IFN-gamma
3. NK cell activity
4. Secretary IgA in saliva
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
3
Treatment
Food |
Continuous consumption of
the RHAMNOX (200 mg)-containing test-food capsule to the volunteers, once a day (after breakfast) for 6 weeks.
Continuous consumption of
the RHAMNOX (100 mg)-containing test-food capsule to the volunteers, once a day (after breakfast) for 6 weeks.
Continuous consumption of
the placebo-food capsule to the volunteers, once a day (after breakfast) for 6 weeks.
50 | years-old | <= |
Not applicable |
Male and Female
(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.
(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.
30
1st name | Masahiro |
Middle name | |
Last name | Terasawa |
KONAN CHEMICAL MANUFACTURING Co Ltd.
Acting Manager
510-0103
1515 Kusu-Cho-Kita-Gomizuka, Yokkaichi-shi, Mie 510-0103, Japan
059-397-2612
info@konanchemical.co.jp
1st name | Mitsuhiro |
Middle name | |
Last name | Fujimoto |
CPCC Company Limited
Planning & Sales Department
101-0047
4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
03-5297-3112
cpcc-contact@cpcc.co.jp
CPCC Company Limited
KONAN CHEMICAL MANUFACTURING Co Ltd.
Profit organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
03-5297-5548
IRB@cpcc.co.jp
NO
2021 | Year | 09 | Month | 29 | Day |
Unpublished
Completed
2020 | Year | 09 | Month | 23 | Day |
2020 | Year | 09 | Month | 18 | Day |
2020 | Year | 09 | Month | 29 | Day |
2020 | Year | 12 | Month | 08 | Day |
2020 | Year | 09 | Month | 24 | Day |
2021 | Year | 09 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047815