Healthy Japanese subjects
Conditions
Interventions
Duration: Eight weeks Test food: Capsule containing black Korean ginseng Administration: Take three capsules per day at any time during the day *Daily dose should be taken within the day. If you
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. Subjects aged between 40 and 60 4. Healthy subjects 5. Subjects whose subjective fatigue measured by VAS (Visual Analogue Scale) is as follows: i) subjective fatigue at pre-workload is between 50 and 80, and ii) the change in subjective fatigue between pre and post-workload is 10 to 20
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 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 who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects whose sleeping time or habit is irregular due to working a late-night shift 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. Subjective fatigue at pre-workload after eight-week consumption (8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The change in subjective fatigue between pre and post-workload after 8w 2. Subjective fatigue at pre-workload after four-week consumption (4w) 3. The change in subjective fatigue between pre and post-workload at 4w 4. Each score of Profile of Mood States 2nd Edition (POMS2) and the OSA sleep inventory MA version (OSA-MA) at 4w and 8w 5. Each item of POMS2 and OSA-MA at 4w and 8w 6. Salivary amylase activity at 4w and 8w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed