Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test material: Capsule containing Korean ginseng Dose: Take 2 capsules containing Korean ginseng per day Administration: Take 2 capsules with water or warm water at any time dur
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects with experiencing unidentified complaints such as being tired, inability to sleep, stiff shoulders, constipation, cold hands and feet, and others 2. Subjects who are considered as appropriate for the study by the physician based on the results of peripheral blood test (endocrine test) 3. Subjects who are considered as appropriate for the study by the physician based on the score on the Beck Depression Inventory 4. Within the subjects who met the 2nd and 3rd inclusion criteria, subjects who get 3-4 points in all of the 5 items, which are fatigue, sleeplessness, stiff shoulders, bowel movement, and cold hands and feet, on the questionnaire about unidentified complaints at screening (before consumption). 5. When subjects below the sample size, subjects who get 1-4 points in all of the 5 items are selected. In the case, we priority select subjects who obtained 1 point in relatively few items.
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, myocardial infarction, endometriosis, uterine myoma, and mental disorders 2. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 3. Subjects who are undergoing medical treatment for erectile dysfunction (ED), prostatic hyperplasia, or a thyroid disorder 4. Subjects who have been diagnosed with a menopausal disorder and no treatment 5. Subjects who are on medication for any other diseases 6. Subjects who have suppurative inflammation (except for small cuts and scratches) 7. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 8. Subjects who currently take sleeping pills or sleep-inducing drugs 9. Subjects who currently take painkillers such as loxoprofen (Loxonin) and others 10. Subjects who currently take other medications (including herbal medicines) and supplements 11. Subjects who are allergic to medicines and/or the test food related products 12. Subjects who are pregnant, breast-feeding, or planning to become pregnant 13. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 14. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A questionnaire about unidentified complaints * Each item is assessed with a seven-point grading scale and the smaller number indicates more severe subjective symptoms. Furthermore, compared the results of the questionnaire at screening (before consumption) and at 4, 8, and 12 weeks after consumption, the grading scale is increased by 3 points and more indicating complete response, by 2 points indicating improvement, by 1 points indicating slight improvement, and by 0 points indicating maintaining health while the grading scale is decreased by 1 point and more indicating worsening. | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed