Proof-of-Science, Prospective, Interventional, Three-arm, Double-Blind, Randomized, Safety and Efficacy Real World Evidence Study.
99 participantsStarted 2024-08-24
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age: 18 to 55 years and above (both inclusive) at the time of consent.
. Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
. Females of childbearing potential must have a self-reported negative urine pregnancy.
. Subject is in good general health as determined by the Investigator on the basis of medical history.
. Female with 40-50 counts and male with 25 -30 counts of hair fall at screening.
. Subject having AGA and premature Gray hair at a time of screening.
. Subject having premature gray hair at a time of screening.
. Subject with pro-claimed nonpathological thinning of hair.
Exclusion criteria
. Subject have history of severe hair fall due to any clinically significant problems like anaemia, thyroid problems.
. Subject have history of any dermatological condition of the scalp other than hair loss and dandruff.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
change in hair thickness by using CASLite Nova
Timeframe: Baseline before usage of test product on Day 01 and after usage of the test products on Day 45 , Day 90 and Day 120
2
change in hair density by using CASLite Nova
Timeframe: Baseline before usage of test product on Day 01 and after usage of the test products on Day 45 , Day 90 and Day 120
3
change in hair growth rate by using CASLite Nova
Timeframe: 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 .
4
change in hair strength by using hair pull test.
Timeframe: 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
5
change in hair fall by using 60 second hair combing test.
Timeframe: 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.
6
change in scalp skin hydration by using Corneometer CM 825
Timeframe: 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
. Subject have history of any prior hair growth procedures (e.g. hair transplant or laser).
. Subject who had taken topical treatment of hair loss for at least 4 weeks.
. Subject who had taken any systemic treatment for at least 3 months.
. History of alcohol or drug addiction.
. Subject having history or resent condition of irritated or visibly inflamed scalp or severe scalp disease.
. Subject having history or present condition of an allergic response to any cosmetic products, any other condition which could warrant exclusion from the study.
7
change in Anagen: Telogen (A: T) Ratio by using Hair Pluck Test by dermatologist.
Timeframe: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 120
8
change in ASFS by using ASFS scoring scale.
Timeframe: 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)
9
change in GSS score by using CASLite Nova
Timeframe: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 120 (+2 days)