Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Tablet containing ripened Korean red ginseng extract Administration: Take two tablets with water at any time during the day. *If you forget to take the test food, ta
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who feel fatigue or stress in daily 3. Subjects who are judged as eligible to participate in the study by the physician 4. Subjects whose amount of changes of VAS of fatigue increased at a relatively larger rate before and after workload
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, myocardial infarction, or mental disorder 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 are undergoing medical treatment for chronic fatigue syndrome or menopausal syndrome 5. Subjects who work late-night shift and the life-styles are irregular 6. Subjects who have physical labor such as transportation of heavy objects 7. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 8. Subjects currently taking medicines (include herbal medicines) and supplements 9. Subjects who are allergic to medicines and/or the test food related products 10. Subjects who are pregnant, breast-feeding, and planning to become pregnant 11. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in another clinical trial during trial period 12. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured value of visual analogue scale (VAS) of fatigue before and after workload at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value of VAS of fatigue before workload at 12w 2. The measured value of VAS of fatigue after workload at 12w 3. The amount of change of VAS of fatigue before and after workload between screening (before consumption; Scr) and 12w 4. The amount of change of VAS of fatigue before workload between Scr and 12w 5. The amount of change of VAS of fatigue after workload between Scr and 12w 6. The measured values and the amount of changes of following items between Scr and 12w: TMD (Total Mood Disturbance), TA (Tension-Anxiety), DD (Depression-Dejection), AH (Anger-Hostility), VA (Vigor-Activity), FI (Fatigue-Inertia), CB (Confusion-Bewilderment), F (Friendliness), and each question item of POMS2 (Profile of Mood States 2nd Edition), LF (Low Frequency), HF (High Frequency), LF/HF, average heart rate, maximum heart rate, minimum heart rate, TP (total power), ccvTP (coefficient of component variance total power), deviation value of autonomic function, autonomic functional age, cortisol level, and amylase activity (evaluate the values before, after, and before and after workload for each variable) 7. The measured values and the amount of changes of d-ROMs and BAP between Scr and 12w 8. The measured values of original questionnaires (The Likert scale method) at 12w weeks after consumption | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed