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

NovoBliss Research

Status: Not yet enrolling

Conditions: Hair Fall and Pre-mature Graying

Treatments: Other: Minoxidil Herbal Hair Oil + Minoxidil 5 (%) Hair Serum; Other: Polyherbal Hair Oil; Other: Minoxidil Hair Serum

Study type: Interventional

Funder types: Other

Identifiers

NCT06552039

NB230043-NB

Details and patient eligibility

About

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.

Full description

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.

• Visit 01 (Day -04): Screening, Tattoo creation, Hair Growth Rate measurement
• Visit 02 (Day 01): Enrolment, Hair Growth Rate measurement, All evaluations
• Visit 03 (Day 45 (±2 days)): Treatment Phase
• Visit 04 (Day 87 (±2 days)): Treatment Phase, Tattoo creation, Hair Growth Rate measurement Visit 05 (Day 90 (3 days from visit 04): Hair Growth Rate measurement, All evaluations
• Visit 06: (Day 120 (±2 days)): End of Treatment Phase, All evaluations

Enrollment: 99 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age: 18 to 55 years and above (both inclusive) at the time of consent.
2. Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
3. Females of childbearing potential must have a self-reported negative urine pregnancy.
4. Subject is in good general health as determined by the Investigator on the basis of medical history.
5. Female with 40-50 counts and male with 25 -30 counts of hair fall at screening.
6. Subject having AGA and premature Gray hair at a time of screening.
7. Subject having premature gray hair at a time of screening.
8. Subject with pro-claimed nonpathological thinning of hair.
9. 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.
10. 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.
11. Subjects are willing to give written informed consent and are willing to follow the study procedure.
12. 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.
13. Willing to use test products throughout the study period.
14. Subject is willing and able to follow and allow study staff to performed study test methods.
15. Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
16. Subject must be able to understand and provide written informed consent to participate in the study

Exclusion criteria

1. Subject have history of severe hair fall due to any clinically significant problems like anaemia, thyroid problems.
2. Subject have history of any dermatological condition of the scalp other than hair loss and dandruff.
3. Subject have history of any prior hair growth procedures (e.g. hair transplant or laser).
4. Subject who had taken topical treatment of hair loss for at least 4 weeks.
5. Subject who had taken any systemic treatment for at least 3 months.
6. History of alcohol or drug addiction.
7. Subject having history or resent condition of irritated or visibly inflamed scalp or severe scalp disease.
8. Subject having history or present condition of an allergic response to any cosmetic products, any other condition which could warrant exclusion from the study.
9. Pregnant or breast feeding or planning to become pregnant during the study period.
10. History of chronic illness which may influence the cutaneous state.
11. Subject have participated any clinical research study related to hair care products.
12. 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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99 participants in 3 patient groups

Polyherbal Hair Oil

Experimental group

Description:

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

Treatment:

Other: Polyherbal Hair Oil

Minoxidil Herbal Hair Oil + Minoxidil 5 (%) Hair Serum

Active Comparator group

Description:

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

Treatment:

Other: Minoxidil Herbal Hair Oil + Minoxidil 5 (%) Hair Serum

Minoxidil Hair Serum

Active Comparator group

Description:

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

Treatment:

Other: Minoxidil Hair Serum