An examination study for evaluating the effects of hearing acuity by consuming the test food: a randomized, placebo-controlled, double-blind, parallel-group comparison study - An examination study for evaluating the effects of hearing acuity by consuming the test food

ORTHOMEDICO Inc.0 sites24 target enrollmentMay 31, 2023

ConditionsHealthy Japanese subjects

Overview

Phase: 未知
Intervention: Not specified
Conditions: Healthy Japanese subjects
Sponsor: ORTHOMEDICO Inc.
Enrollment: 24
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 31, 2023

End Date

December 24, 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, neurological disease, insomnia, sleep disorder, labyrinth disease, or any other chronic diseases 4\. Subjects who use or take "Foods for Specified Health Uses," "Foods with Functional Claims," or "Foods with Nutrient Function Claims" in daily 5\. Subjects who are currently taking medications (including herbal medicines), internal quasi\-drugs, or supplements 6\. Subjects who drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1\.5 cans of canned chu\-hi, 180 mL: 1 go of sake or about 1\.5 glasses of wine, 90 mL: half\-go with shochu, 60 mL: a glass of whiskey brandy (double)} 7\. Subjects who have a smoking habit 8\. Subjects who have difficulty maintaining a constant lifestyle during this trial, such as those who plan to make significant changes in their lifestyle (such as diet, sleep, and exercise), work night shifts or other rotating shifts, or plan to travel abroad 9\. Subjects who have not been getting enough sleep 10\. Subjects who have constipation 11\. Subjects who are allergic to medicines and/or the test food related products 12\. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 13\. Subjects who suffer from COVID\-19 14\. 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 15\. Subjects who are judged as ineligible to participate in this study by the physician