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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000041891
Enrollment
30
Registered
2021-09-29
Start date
2020-09-29
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy male/female adults

Interventions

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 t

Sponsors

CPCC Company Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Variations in influenza-antibody titer

Secondary

MeasureTime frame
1. High sensitive IL-4 2. High sensitive IFN-gamma 3. NK cell activity 4. Secretary IgA in saliva

Countries

Japan

Contacts

Public ContactMitsuhiro Fujimoto

CPCC Company Limited Planning & Sales Department

cpcc-contact@cpcc.co.jp03-5297-3112

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026