This is proof-of-science, prospective, interventional, three-arm, double-blind, randomized, safety and efficacy real world evidence study of herbal and non herbal formulations in healthy human subjects having complaint of hair fall and pre-mature graying.
Considering the clinical safety, efficacy study a sufficient number 99 subjects (33 subject/arm) will be enrolled to 90 subjects (30 subject/arm) completed the study. In each arm, fifteen (15) participants per group will be recruited, with one group consisting of individuals experiencing mild to moderate Androgenetic Alopecia (AGA) class 1, 2, 3, while the other group will comprise fifteen (15) healthy subjects with symptoms of hair loss and premature graying. The potential subjects will be screened as per the inclusion \& exclusion criteria only after obtaining written informed consent from the subjects. The adult female/male subjects will be instructed to visit the facility as per the below visits. * Visit 01 (Day -04): Screening, Tattoo creation, Hair Growth Rate measurement * Visit 02 (Day 01): Enrolment, Hair Growth Rate measurement, All evaluations * Visit 03 (Day 45 (±2 days)): Treatment Phase * Visit 04 (Day 87 (±2 days)): Treatment Phase, Tattoo creation, Hair Growth Rate measurement Visit 05 (Day 90 (3 days from visit 04): Hair Growth Rate measurement, All evaluations * Visit 06: (Day 120 (±2 days)): End of Treatment Phase, All evaluations
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
99
Apply oil with the help of fingertips on your scalp and massage it gently enabling it to penetrate into the roots (follicle) of your hair. Don't apply with your palms and never rub it vigorously as it may uproot weak hair. Let the oil gradually seep into follicle of your hair \& nourish them for the whole night. The oil may be removed in the morning by washing of hair with Ayurvedic Shampoo. Dosage form: liquid frequency: Three times a week Route of Administration: Topical
First, apply the herbal hair oil generously to your scalp and hair, ensuring thorough coverage. Gently massage it in with your fingertips to promote circulation and absorption. After the oil application, follow the instructions provided for the application of the minoxidil hair serum. Apply the serum to the areas of your scalp where you desire hair growth, using the dropper provided or as directed. Massage it gently into your scalp to ensure even distribution and absorption. Leave the serum on without rinsing. Dosage form: liquid Frequency : For Minoxidil - Daily Night Application For Herbal Hair Oil- Thrice a week. Route of Administration: Topical
change in hair thickness by using CASLite Nova
To assess the effectiveness of the test products in terms of change in hair thickness by using CASLite Nova.
Time frame: Baseline before usage of test product on Day 01 and after usage of the test products on Day 45 , Day 90 and Day 120
change in hair density by using CASLite Nova
To assess the effectiveness of the test products in terms of hair density by using CASLite Nova.
Time frame: Baseline before usage of test product on Day 01 and after usage of the test products on Day 45 , Day 90 and Day 120
change in hair growth rate by using CASLite Nova
To assess the effectiveness of the test products in terms of change in hair growth rate by using CASLite Nova
Time frame: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45 , Day 90 and Day 120 .
change in hair strength by using hair pull test.
To assess the effectiveness of the test products in terms of change in hair strength by using hair pull test
Time frame: Baseline before usage of the test products (04 days before Day 01) and after usage of the test on Day 45, Day 90 and Day 120
change in hair fall by using 60 second hair combing test.
To assess the effectiveness of the test products in terms of change in hair fall by using 60 second hair combing test.
Time frame: Baseline before usage of the test products (04 days before Day 01) and after usage of the test on Day 45, Day 90 and Day 120.
change in scalp skin hydration by using Corneometer CM 825
To assess the effectiveness of the test products in terms of change in scalp skin hydration
Time frame: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and Day 120
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Apply the amount prescribed to the area of the scalp being treated, beginning in the center of the area. Dosage form: liquid Frequency : Daily night Application of Minoxidil Route of Administration: Topical
change in Anagen: Telogen (A: T) Ratio by using Hair Pluck Test by dermatologist.
To assess the effectiveness of the test products in terms of change in Anagen: Telogen (A: T) Ratio
Time frame: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 120
change in ASFS by using ASFS scoring scale.
To assess the effectiveness of the test products in terms of change in ASFS where 0-10 scale (0 means no flakes and 10 means heavy flaking)
Time frame: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45 (+2 days), Day 90 (3 days from the visit 04) and Day 120 (+2 days)
change in GSS score by using CASLite Nova
To assess the effectiveness of the test products in terms of change in GSS score
Time frame: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 120 (+2 days)
change in general appearance of hair
To assess the effectiveness of the test products in terms of change in general appearance of hair where categorical variable indicated as poor, average and good scale
Time frame: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and Day 120.
change in general appearance of scalp.
To assess the effectiveness of the test products in terms of change in general appearance of scalp where categorical variable indicated none, mild, moderate and excessive
Time frame: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45 , Day 90 and Day 120.
change in digital photographs of the head crown Nikon digital camera D3300
To assess the effectiveness of the test products in terms of change in digital photographs of the head crown
Time frame: Before usage of the test products on Day 01 and after usage of the test products on Day 45 , Day 90 and Day 120.
change in products perception questionnaire by using 5-point Likert scale
To evaluate the effectiveness of the test products in terms of change in products perception questionnaire
Time frame: Before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and Day 120
sensorial evaluation on the hair tress by 6 expert evaluation.
To assess the effectiveness of the test products in terms of sensorial evaluation on the hair tress by 6 expert evaluation
Time frame: Baseline and post application of the test products on Day 1 at T 60 minutes
change in hair shine using glossymeter GL 200
To assess the effectiveness of the test products in terms of change in hair shine using glossymeter GL 200
Time frame: Baseline and post application of the test products on Day 1 at T 60 minutes
change in damage repair of the hair by using SEM analysis
To assess the effectiveness of the test products in terms of change in damage repair of the hair by using SEM analysis
Time frame: Baseline on Day 1 and post application of the test products at 120 Days
change in lipid deposition of the hair by using XRF method
To assess the effectiveness of the test products in terms of change in lipid deposition of the hair by using XRF method
Time frame: Baseline on Day 1 and post application of the test products at 120 Days