Healthy Japanese subjects
Conditions
Interventions
Duration: 3 weeks Test food: KRG-A Administration: 2 capsules/day (Take 2 capsules with water at any time during the day) * Daily dose should be taken within the day. If you forget to take the ca
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese male and female 2. 40-60 years of age 3. Healthy individual 4. Subjects who feel fatigue daily 5. Within the subjects who met 1st to 4th inclusion criteria (1, 2, 3, 4), subjects whose VAS of fatigue are relatively high
Exclusion criteria
Exclusion criteria: 1. Subjects undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction 2. Subjects carrying a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage, including Ginseng products, as part of their daily intake 5. Subjects currently regularly taking medications (including herbal medicines) and supplements 6. Subjects allergic to medications and/or the test-food related products 7. Subjects who are pregnant, breast-feeding or planning for pregnancy 8. Subjects who are being infected with COVID-19 9. Subjects who have been enrolled in other clinical trials within 28 days before the agreement to participate in this trial or plan to enroll in another clinical trial during trial period 10. Subjects who are deemed ineligible to participate in the study by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured values of Visual Analogue Scale (VAS) scores at 3 weeks after the start of test-food consumption. | — |
Secondary
| Measure | Time frame |
|---|---|
| The measured values of plasma cortisol and lactate levels at 3 weeks after the start of test-food consumption. | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed