Health Condition 1: L649- Androgenic alopecia, unspecified
Conditions
Interventions
Intervention1: Plant Keratin: Dose: One capsule (400mg) containing 250 mg of plant
keratin,
Dosage form: Capsule,
Frequency: Once daily with dinner for 12 weeks,
Route of administration: Oral
Control
Sponsors
Vidya Herbs Pvt Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects in general good health. 2. Subjects aged 20-50 years (both the ages inclusive). 3. Selection of AGA subjects based on Norwood Hamilton scale (male) and Ludwig scale (female). 4. Subjects willing to give written informed consent and willing to abide by and comply with the study protocol. 5. Hair density of greater than 100 and less than 200 hair follicles per square cm as per Trichoscan measurement. 6. The subjects who agree to refrain from using hair dye/hair color during the study period.
Exclusion criteria
Exclusion criteria: 1. Subjects who have undergone hair growth treatment within 3 months before screening into the study. 2. Subjects having any active scalp disease which may interfere with the study dermatologists judgment. 3. Subjects who have taken chemotherapy for cancer in the 6 months before the start of the study or have a plan to do treatments during the study. 4. Subjects who have a history of alcoholism, smoking, crash dieting, and/ or psychiatric disorders including trichotillomania. 5. Subjects who have had hair transplants, who have taken pharmaceutical products which cause hirsutism (ex. phenytoin) and finasteride for androgenic alopecia, under medical treatment for hair problems. 6. A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products. 7. Subjects on oral medications, undergoing any chemical hair salon treatment-straightening / perming/colour/ henna which will compromise the study. 8. Subjects with chronic illness which may influence the cutaneous state. 9. Subjects who are pregnant or lactating or nursing as established with medical history. 10. Menopausal female subjects as determined by medical history. 11. Subjects participating in other similar cosmetic or therapeutic trials within the last three months. 12. Subjects with any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorders of heart and respiratory apparatus, or any other serious medical illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in hair shedding in Comb test and Hair pull testTimepoint: Baseline, Week 4, Week 8, Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Hair density Timepoint: Baseline, Week 12;ThicknessTimepoint: Baseline, Week 12;A/T ratio- (Trichoscan analysis)Timepoint: Baseline, Week 12 ;Hair assessment for smoothness, shine Timepoint: Baseline, Week 12;Scalp & hair health assessmentTimepoint: Baseline, Week 12;Digital PhotographyTimepoint: Baseline, Week 12;Perceived self-assessment questionnaire (Hair growth index scale)Timepoint: Baseline, Week 12;Norwood Hamilton scaleTimepoint: Baseline, Week 12;Ludwig scaleTimepoint: Baseline, Week 12 | — |
Countries
India
Contacts
Public ContactDr Bhargav Bhongiri
Syncorp Health Pvt. Ltd.
Outcome results
None listed