JPRN-UMIN000048608
Completed
未知
Effects of consumption of the test food on subjective tinnitus in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study - Effects of consumption of the test food on subjective tinnitus in healthy Japanese subjects
ConditionsHealthy Japanese subjects
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Healthy Japanese subjects
- Sponsor
- ORTHOMEDICO Inc.
- Enrollment
- 66
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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\. who are undergoing medical treatment or have a medical history 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 take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use 5\. who currently taking medications (including herbal medicines) and supplements 6\. who are allergic to medicines and/or the test food related products 7\. who are pregnant, lactation, or planning to become pregnant during this trial 8\. who suffer from COVID\-19 9\. 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 10\. who have medical treatment, prescription, or lifestyle counseling by a doctor due to tinnitus 11\. who have medical treatment or prescription by a doctor due to ear disease (such as sudden hearing loss, acoustic neuroma, Meniere's disease, otitis media, otosclerosis, or otitis externa), or who have a medical history of severe ear disease 12\. who have undergone otological surgery (such as cochlear implantation, meatoplasty, tympanoplasty, or stapes surgery) 13\. who use devices to assist hearing such as hearing aid 14\. who have medical treatment or prescription by a doctor due to psychiatric disorder (such as depressive disorder, bipolar disorder, schizophrenia, panic disorder, or obsessive\-compulsive disorder) 15\. whose sleeping time or habit is irregular due to working a late\-night shift 16\. who are judged as ineligible to participate in the study by the physician
Outcomes
Primary Outcomes
Not specified
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