Proof-of-Science, Prospective, Interventional, Three-arm, Double-Blind, Randomized, Safety and Efficacy Real World Evidence Study.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorNovoBliss Research Pvt Ltd

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Polyherbal Hair Oil

    Other intervention

    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

    Other intervention

    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 intervention

    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

Treatment groups

99 Participants
are divided into 3 treatment groups
Group A: Polyherbal Hair OilExperimental treatment 1 intervention
Group B: Minoxidil Herbal Hair Oil + Minoxidil 5 (%) Hair SerumActive comparator 1 intervention
Group C: Minoxidil Hair SerumActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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 .
4

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

Secondary outcomes

1

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.
2

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.
3

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.
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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