None listed
Conditions
Interventions
Intervention1: H-Vit Hair Serum: Dose: To be used as per instructions on the bottle and as instructed by the Investigator
Dosage: To be used as per instructions on the bottle and as instructed by the
Sponsors
Systopic Laboratories Private Limited
Aurous HealthCare Research and Development India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Clinically healthy adult subjects who are routinely being prescribed H-Vit Hair Serum of Systopic Laboratories, between the ages of 21 and 55 years - both ages and all genders inclusive, looking to improve their hair health. 2. Subjects with complaints of non-associated excessive hair fall, brittle or thin hair, dull hair, dry or damaged hair. 3. Subjects who are willing to abstain from the use of any oral or topical medications not limited to collagen, biotin supplements indicated and improving hair fall and other hair health parameters. 4. Subjects who are willing to give informed consent for participation, able to comprehend and understand the responsibilities during screening and treatment period. 5. 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 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 anaemia 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 the 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 or 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 study 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 is unstable or 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. Hair Assessment - Investigator Questionnaire - Increase of greater than or equal to 7 scores in total score compared to baseline 2. Hair Assessment -Subject Questionnaire - Increase of greater than or equal to 10 scores in total score compared to baseline 3. Product Satisfaction Questionnaire - Score of greater than or equal to 30 at the end of the study. 4. Product Satisfaction Questionnaire - Score of 50 at the end of the study. Timepoint: 1.Hair Assessment - Investigator Questionnaire - Day 1, Day 45, Day 90 2.Hair Assessment - Subject Questionnaire - Day 1, Day 45, Day 90 3. Product Satisfaction Questionnaire - Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr VT Sriraam
Aurous HealthCare Research and Development India Pvt Ltd
Outcome results
None listed