A verification study of the immunostimulatory effects: a randomized, placebo-controlled, double-blind, parallel-group comparison study - A verification study of the immunostimulatory effects

ORTHOMEDICO Inc.0 sites44 target enrollmentDecember 5, 2022

ConditionsHealthy Japanese subjects

Overview

Phase: 未知
Intervention: Not specified
Conditions: Healthy Japanese subjects
Sponsor: ORTHOMEDICO Inc.
Enrollment: 44
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 5, 2022

End Date

March 26, 2023

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

ORTHOMEDICO Inc.

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•1\. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2\. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3\. Subjects 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\. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5\. Subjects who are currently taking medications (including herbal medicines) and supplements 6\. Subjects who are allergic to medicines and/or the test food related products 7\. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 8\. Subjects 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 9\. Subjects who are smokers 10\. Subjects who have a past or current medical history of respiratory disease 11\. Subjects who have autoimmune disease 12\. Subjects who have a history of salivary glands treatment 13\. Subjects who use immunosuppressants such as steroid 14\. Subjects who have received vaccination for influenza within the last three months 15\. Subjects who have an exercise habit with 4\.0 METs or more (such as vigorous running) 16\. Subjects who are judged as ineligible to participate in this study by the physician