Proof-of-Science, Prospective, Interventional, Three-arm, Double-Blind, Randomized, Safety and Efficacy Real World Evidence Study.
Scientific Evaluation of the Safety and Efficacy of Herbal and Non Herbal Formulations in Mitigating Hair Fall, Promoting Hair Growth, and Preventing Premature Hair Graying.
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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
completed
Actual enrollment (reported)
99 participants
Study completion date
June 28, 2025
Actual (reported)
Listed locations
1 countries · 1 sites
Trial Relationships
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Related Scientific Literature
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
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 Outcomes (8)
change in general appearance of hair
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.
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
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
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.
Baseline and post application of the test products on Day 1 at T 60 minutes
+3 more secondary outcomes
Study Arms (3)
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
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
Interventions
Polyherbal Hair OilOther
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
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
Other: Minoxidil Hair Serum
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
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
Minoxidil Hair Serum
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will beconsidered as non-childbearing potential if they are surgically sterile, have been post menopausal for at least 1 year or have had a tubal ligation.
Subjects are willing to give written informed consent and are willing to follow the study procedure.
Subjects who commit not to use any other medicated/ prescription shampoos/hair care products (containing Minoxidil), any other hair growth products or hair colour or dye, other than the test products for the entire duration of the study.
Willing to use test products throughout the study period.
Subject is willing and able to follow and allow study staff to performed study test methods.
Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
+1 more criteria
You may not qualify if:
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.
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.
Pregnant or breast feeding or planning to become pregnant during the study period.
History of chronic illness which may influence the cutaneous state.
Subject have participated any clinical research study related to hair care products.
Subject have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
Contact the study team to confirm eligibility.
Primary Completion
June 28, 2025
Actual (reported)
Study Completion
June 28, 2025
Actual (reported)
Last Updated
August 6, 2026
Record last verified: 2026-08
Data Sharing
IPD Sharing
Will not share
Source record
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Source: ClinicalTrials.gov.
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