None listed
Conditions
Interventions
Intervention1: 1. Hair Oil
2. Shampoo
3. Hot Oil (Hamamzaith)
4. Oil Replacement: 1. Once in a week
2. Thrice in a week
3. Once in a week
4. Thrice in a week
Control Intervention1: Not Applicable: Not
Sponsors
Dabur International Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 18 to 65 years (both inclusive) at the time of consent. 2) Sex: Healthy non-pregnant/non-lactating females. 3) Females of Childbearing potential must have a negative urine pregnancy test performed on screening visit. 4) Subjects generally in good health. 5) Subjects having 50 to 100 hair fall per day. 6) Females with 50 count of hair fall from hair combing method (60-sec hair count) at screening visit (if screening and enrollment on same day) or on enrollment day before treatment. 7) Subjects willing to give written informed consent and willing to follow study procedure. 8) Subjects who have used other marketed product for hair fall control in the past. 9) Subjects willing to refrain from any other treatment for the main indications for which the study test products are being given during the course of the study. 10) Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil / Anti-hair fall agents) or any other hair fall treatment/ hair products other than the test product for the entire duration of the study. 11) Willing to use test product throughout the study period.
Exclusion criteria
Exclusion criteria: 1) Subjects with history of severe Hair fall due to any clinically significant problems/s like anaemia, thyroid problems etc. 2) History of any dermatological condition of the scalp other than hair loss and/or dandruff. 3) History of prior use of scalp hair growth treatment within 3 months. 4) History of any prior hair growth procedures (e.g., hair transplant or laser). 5) Subjects who have applied topical treatment for hair loss for at least 4 weeks and any systemic treatment for at least 3 months, prior to their participation in the study. 6) History of alcohol or drug addiction. 7) Subjects using other marketed hair fall control products during the study period. 8) Subjects who have plans of shaving of scalp hair during the course of the study. 9) Subjects who are on chronic oral steroids 03 months before initial application and during the study period. 10) History or present condition of irritated or visibly inflamed scalp or severe scalp disease. 11) Subjects having a history or present condition of an allergic response to any cosmetic products. 12) Any other condition which could warrant exclusion from the study, as per the dermatologistâ??s/investigatorâ??s discretion. 13) Pregnant or breastfeeding or planning to become pregnant during the study period. 14) History of chronic illness which may influence the cutaneous state. 15) Subjects participating in other similar cosmetic or therapeutic trial within last two weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percentage change in hair fall reduction after 12 weeks of treatment from Baseline on Day 01 before treatment to Day 21, Day 45, Day 63 and Day 90 (±2 Days) after treatment using 60-S Hair count technique.Timepoint: Baseline on Day 01 before treatment, after treatment on Day 21, Day 45, Day 63 and Day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in general appearance of hair (Hair Volume, Hair Density, Hair Plasticity, Hair strength, Hair smoothness, Hair Oiliness, Shininess), Change in appearance of scalp skin (itchiness, redness, roughness and scaliness of scalp), Change in hair shine, hair strength & hair frizziness, Measuring overall quality of hair i.e. Hair Thickness, Hair Density and Scalp condition & Product perception. 2. Measuring hair growth phase i.e. % anagen hairs, % telogen hairs and A:T ratio. Timepoint: 1. Baseline Day 01 before treatment, after treatment on Day 21, 45, 63, 90. 2. Baseline Day 01 before treatment, after treatment on Day 90. | — |
Countries
India
Contacts
Public ContactMs Maheshvari Tamboli
Cliantha Research
Outcome results
None listed