Healthy Japanese subjects
Conditions
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy subjects 5. Subjects who feel shoulder stiffness when performing VDT operation 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects whose "my shoulders and neck are stiff" after VDT load is relatively large
Exclusion criteria
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 who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects whose the cause of eye diseases, entropion, trichiasis, rotator cuff tear, meningitis, high astigmatism, high myopia, premature ovarian failure, tension-type headache, shoulder stiffness can be considered other than fatigue associated with VDT operation. 5. Subjects who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use 6. Subjects who currently taking medications (including herbal medicines) and supplements 7. Subjects who are allergic to medicines and/or the test food related products 8. Subjects who are pregnant, lactation, or planning to become pregnant 9. Subjects who suffer from COVID-19 10. 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 11. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Result of participant responding "My shoulder and neck are stiff" using subjective symptoms assessment with Likert scale after VDT (visual display terminals) load at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Result of participant responding "My shoulder and neck are stiff" using subjective symptoms assessment with Likert scale before VDT load at 12w 2. Result of participant responding the following items using subjective symptoms assessment with Likert scale before and after VDT load at 12w: "my eyes are tired", "my eyes are painful", "my vision is blurred", "I have tears", "I have bloodshot eyes", "my vision flickers", "I have double vision", "I am annoyed", "my head feels heavy", and "I have a headache" 3. The muscular stiffness of shoulders, and HFC-1 (high frequency component) measured using the autorefkeratometer at 12w (before and after VDT load and the difference between them) | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed