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A study for evaluating the immunostimulating effect -A Randomized, double-blind, placebo controlled trial.

A study for evaluating the immunostimulating effect -A Randomized, double-blind, placebo controlled trial. - A study for evaluating the immunostimulating effect

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000021989
Enrollment
40
Registered
2016-04-19
Start date
2016-04-20
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 adults who feel fatigue

Interventions

Test food Duration: 4 weeks Dose: daily recommended dose Usage: intake at optional timing Placebo food Duration: 4 weeks Dose : daily recommended dose Usage: intake at optional timing

Sponsors

ORTHOMEDICO, Inc.
Lead Sponsor
Seishin-kai medical Association Inc, Takara clinic.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: a) Healthy adults, who feel fatigue b) Persons whose ages are 20 years or older c) Low immunity score (scoring immunological vigor: between 13 and 23) on visit 1's examination

Exclusion criteria

Exclusion criteria: a) Persons who have previous medical history of cancer, heart failure and cardiacinfarction b) Patients being treated for arterial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes, digestive system disorder, autoimmune disorder, dyslipidemia, hypertension, and other chronic disease c) Persons who takes medicines, herbal medicines, and dietary supplements d) Persons who take in foods with an influence on Primary outcomes to more than three times a week in large quantities e) Persons who take in foods with an influence on intestinal regulation to more than three times a week in large quantities f) Persons who has allergy g) Pregnant women, lactating women, or women who want to get pregnant during the trial period h) Persons who enrolled in the other clinical trials within last 3 months before the agreement for the participation to the trial i) Persons who investigator judge not suitable to participate in the trial

Design outcomes

Primary

MeasureTime frame
Scoring of Immunological Vigor after 4 weeks of intervention

Secondary

MeasureTime frame
Immunological parameters Physical examinations Urinary test Blood test Questionnaires (Likert) :after 4 weeks of intervention

Countries

Japan

Contacts

Public ContactNaoko SUZUKI

ORTHOMEDICO, Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

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