None listed
Conditions
Interventions
Intervention1: H-Vit Hair Serum: Product is provided in a 60 ml bottle with spray nozzle
Spray the product on the palm of one hand.
Rub hands together to spread the product
Apply the product from roo
Sponsors
Systopic laboratories Private Limited,
Aurous HealthCare Research and Development India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Clinically healthy adult subjects between the ages of 21 and 55 years both ages and all genders inclusive looking to improve their hair health. 2. Subjects who agree not to dye or colour, cut or trim, straightening or other cosmetic treatments and or under go any hair treatments not limited to hair spa at beauty saloons or parlours for the duration of participation in the clinical study. 3. Subjects with complaints of non associated excessive hair fall, brittle or thin hair, dry or damaged hair. 4. Subjects who are willing to abstain from the use of any dedicated products not limited to hair oil, shampoo, conditioner, hair mask, hair serum, hair treatments and remedies to improve hair fall and other hair health parameters. 5. Subjects who are willing to abstain from the use of any oral or tropical medications not limited to collagen, biotin supplements indicated and improving hair fall and other hair health parameters. 6. Subjects who are willing to give informed consent for participation, able to comprehend ad understand the responsibilities during screening and treatment period 7. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
Exclusion criteria
Exclusion criteria: 1. Subjects with known hypersensitivity to the ingredients of the investigational product. 2. Subjects who have had an active trichological procedure done upto 3 months prior to screening Subjects who have dyed their hair upto 30 days prior to screening 3. Subjects who have scalp conditions not limited to seborrheic dermatitis, psoriasis, alopecia areata, significant scalp scarring that prevents proper examination or evaluation of study criteria. 4. Subjects with Trichotillomania 5. Subjects who have anemia or iron deficiency. 6. Subjects who have previously undergone hair transplantation procedures. 7. Subjects who have an active infection, disease or disorder that will prevent them from fully satisfying their responsibilities of the study. 8. Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc. 9. Subjects suffering from, on remission from cancer of any type less than 5 years at the time of screening. 10. Subjects who are planning a pregnancy and, or currently breastfeeding 11. Subjects who have participated in a clinical trial less than 1 month before screening. 12. Any significant medical condition e.g., significant psychiatric or neurological disorders, active alcohol or drug abuse etc., any medical condition that unstable, poorly controlled or other factor e.g., planned relocation that the investigator felt would interfere with study evaluations and study participation. 13. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol 14. Subjects who in the opinion of the investigator are not eligible for enrolment in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. 60 Second Hair Comb Test: Reduction of greater than or equal to 50 percent from Baseline 2. Visual Scalp Assessment: Increase of greater than or equal to 10 scores from base line 3. Hair Growth Questionnaire: Total score lesser than or equal to 10 at end of study 4. Product Satisfaction Questionnaire: Total score of greater than or equal to 5 at end of study Timepoint: 1. 60 Second Hair Comb Test : Day 1, Day 45, Day 90 2. Visual Scalp Assessment : Day 1, Day 45, Day 90 3. Hair Growth Questionnaire : Day 45, Day90 4. Product Satisfaction Questionnaire : Day90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicableTimepoint: Not applicable | — |
Countries
India
Contacts
Public ContactDr VT Sriraam
Aurous HealthCare R&D India Pvt. Ltd.
Outcome results
None listed