Proof-of-Science, Prospective, Interventional, Three-arm, Double-Blind, Randomized, Safety and Efficacy Real World Evidence Study.
NCT Number: NCT06552039
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hair Fall and Pre-mature Graying
Interventions: OTHER: Polyherbal Hair Oil|OTHER: Minoxidil Herbal Hair Oil + Minoxidil 5 (%) Hair Serum|OTHER: Minoxidil Hair Serum
Sponsor: NovoBliss Research Pvt Ltd
Sex: ALL
Age: ADULT
Enrollment: 99
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2024-08-24
Completion Date: 2024-12-24

Summary:
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.

Primary Outcome Measures: 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, 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)
Secondary Outcome Measures: 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.|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