A verification study of the immunostimulatory effects: an open-label trial - A verification study of the immunostimulatory effects

ORTHOMEDICO Inc.0 sites16 target enrollmentJanuary 1, 2024

ConditionsHealthy Japanese subjects

Overview

Phase: 未知
Intervention: Not specified
Conditions: Healthy Japanese subjects
Sponsor: ORTHOMEDICO Inc.
Enrollment: 16
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 1, 2024

End Date

February 5, 2023

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

ORTHOMEDICO Inc.

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Subjects 1\. who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2\. who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3\. currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4\. who usually take "Foods for Specified Health Uses," or "Foods with Functional Claims" / particularly who use dietary fiber ingredients (such as fructo oligosaccharide, indigestible dextrin, and polydextrose) or dietary supplements for the immunostimulation 5\. who are currently taking medications (including herbal medicines or immunosuppressants such as steroid) and supplements 6\. who are allergic to medicines and/or the test food related products or have seasonal allergic rhinitis (hay fever), perennial allergic rhinitis, asthma, atopic dermatitis, allergic conjunctivitis, food allergy, or metal allergy 7\. who are pregnant, lactating, or planning to become pregnant during this trial 8\. who have received preventive vaccination for influenza within the last three months 9\. who have undergone or plan to undergo dental or oral treatment {treatment of dental decay, periodontal disease, or others, including periodic scaling (dental cleaning)} between one month prior to the agreement to participate and completion of this trial 10\. who have bleeding tooth or oral problems such as stomatitis 11\. who work in shifts or physical labor such as transportation of heavy objects 12\. who suffer from COVID\-19 13\. who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 14\. who are judged as ineligible to participate in this study by the physician