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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polyherbal Hair Oil | Experimental | 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 |
|
| Minoxidil Herbal Hair Oil + Minoxidil 5 (%) Hair Serum | Active Comparator | 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 Frequency: For Minoxidil - Daily Night Application For Herbal Hair Oil- Thrice a week Route of Administration: Topical |
|
| Minoxidil Hair Serum | Active Comparator | Apply the amount prescribed to the area of the scalp being treated, beginning in the center of the area. Frequency: Daily Night Application of Minoxidil Route of Administration: Topical |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyherbal Hair Oil | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 | 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 | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maheshvari N Patel | Contact | 09909013236 | maheshvari@novobliss.in | |
| Sheetal J Khandwala | Contact | bd@novobliss.in |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Nayan K Patel | NovoBliss Research Pvt Ltd | Principal Investigator |
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Proof-of-Science, Prospective, Interventional, Three-arm, Double-Blind, Randomized, Safety and Efficacy
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| Minoxidil Herbal Hair Oil + Minoxidil 5 (%) Hair Serum | Other | 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 |
|
| Minoxidil Hair Serum | Other | 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 |
|
To assess the effectiveness of the test products in terms of change in scalp skin hydration
| 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 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 | 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) | 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 | 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 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 |
| 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 | 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 | 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 | 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 | 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 | 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 | Baseline on Day 1 and post application of the test products at 120 Days |