Effects of consumption of the test food on hair growth or hair

UMIN ID: UMIN000051529

Registered date:01/06/2024

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy Japanese subjects
• Date of first enrollment: 2023/07/05
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 should be taken within the day and not carried over to the next day.
Duration: 20 weeks Test food: Anti-gray hair 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 should be taken within the day and not carried over to the next day.
Non intake

Outcome(s)

• Primary Outcome: 1. The number of hairs and the percentage of gray hair at four, 12, and 20 weeks after consumption (4w, 12w, and 20w)
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: ORTHOMEDICO Inc.
• Secondary Sponsor: Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
• Source(s) of Monetary Support: Milbon Co., Ltd.