Healthy Japanese subjects
Conditions
Interventions
Duration: Four weeks Test food: Ginger capsule Administration: Take one capsule in the morning. *If you forget to take the test food, take it as soon as you remember. Daily dose should be taken w
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 are aware that they are easily fatigued due to desk work, etc. on a daily basis 6. Subjects whose the difference in subjective fatigue measured by VAS between before and after workload (after load-before load) with the Uchida-Kraepelin test at Scr is relatively large in the positive direction among study participants 7. Subjects who are judged as eligible to participate in the study by the physician
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 diseases: 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 are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 8. 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 9. Subjects who are undergoing medical treatment or have a medical history of chronic fatigue syndrome 10. Subjects who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of the difference in subjective fatigue measured by visual analogue scale (VAS) between before and after workload (after load-before load) with the Uchida-Kraepelin test at four weeks after consumption (4w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value of subjective fatigue measured by VAS before and after workload at 4w 2. The amount of changes in the difference in subjective fatigue measured by VAS between before and after workload and each value before and after workload from screening (before consumption; Scr) to 4w 3. The measured value and amount of change from Scr of urinary isoprostane at 4w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed