Healthy Japanese subjects
Conditions
Interventions
Duration: 20 weeks Test food: Hair growth supplement Administration: Take three capsules with water once daily. *If you forget to take the test food, take it as soon as you remember. Daily dose s
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 voluntarily consent to participate in this trial 6. Subjects who have been suffering from thinning hair or gray hair for the past two years
Exclusion criteria
Exclusion criteria: Subjects (who/whose) 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. 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. have a past or current medical history of atopic dermatitis, who have bronchial asthma, conjunctivitis, or atopic dermatitis, or whose family members have any of these diseases 5. may develop allergic rhinitis or who plan to take medication for symptom relief during this trial 6. have any symptoms (e.g., diseases such as urticaria, inflammation, eczema, external wound, acne, boil, wart, or traces of them) on the skin at evaluation sites (face or cephalon) that may influence the results of this study 7. have undergone or plan to undergo any special procedures (such as hair transplantation or hair extension) within the last four weeks or during this trial 8. shaving of their head will interfere with their daily life 9. cannot collect hair due to short hair such as shaved hair 10. use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 11. are currently taking medications (including herbal medicines) and supplements 12. are allergic to medicines and/or the test food related products 13. have a medical history of drug or alcohol dependence 14. are pregnant, lactating, or planning to become pregnant during this trial 15. 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 16. are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The number of hairs and the percentage of gray hair at four, 12, and 20 weeks after consumption (4w, 12w, and 20w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The percentage of vellus hair, the percentage of non-vellus hair, the percentage of anagen hair, the density of hair, the number of fallen hair, an original questionnaire using visual analogue scale (VAS) (the amount of gray hair, thinness of hair on the head, the amount of hair loss on the head, stickiness of head and scalp, condition of the firmness of the hair, condition of dandruff, volume of hair) at 4w, 12w, and 20w 2. The scalp condition at 4w, 12w, and 20w. | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed