Health Condition 1: null- Mild to moderate Hair loss in females
Conditions
Interventions
Intervention1: EM/HO-01: Dosage and Treatment Duration: 5 to 10 ml hair oil daily on the scalp with fingertips before going to bed at night or before bath for 60 days
Control Intervention1: NIL: NIL
Sponsors
Emami Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Female subjects between the age group of 18- 45 years both inclusive. 2.Subjects suffering from mild to moderate hair loss (40-140 Hair by Comb test and Finger Test). 3.Subjects who are infrequent hair oil users. 4.Subjects who are willing to give informed consent and ready to comply with the protocol. 5.Subjects who are ready to provide regular follow ups till the completion of the study.
Exclusion criteria
Exclusion criteria: 1.Subjects with severe Hair fall due to any clinically significant disorder/s like anemia, thyroid disorders etc. 2.Subject with severe dermatological disorders of the scalp that might interfere with the study evaluation. 3.Subjects with recent disease history like malaria, typhoid, jaundice and scalp diseases and subjects who in the opinion of the investigator are not eligible for enrollment in the clinical study. 4.Subjects who have regularly used anti-hair fall treatment with hair oil over the last 6 months. 5.Subjects who have previously undergone hair transplantation procedures. 6.Subjects on systemic steroids for more than 14 days within 2 months prior to enrollment. 7.Subjects on immunosuppressive drugs. 8.Known cases of Hypersensitivity to hair oil contents. 9.Subjects who have participated in any other clinical study since last 3 months. 10.Subjects who are reported pregnant/planning a pregnancy or lactating. 11.Menopausal Women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Assessment of hair fall by running finger test over a period of 60 days. 2. Assessment of hair breakage by comb test over a period of 60 days Timepoint: Day -3, Day 0, Day 15, Day 30, Day 45, Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Assessments of hair fall by Hair Pull test. 2.Assessment of hair growth by comparing against standard nonusers. 3.Assessment of effect of hair oil on dandruff in females by standard dandruff evaluation strip. 4.Assessment of effect of hair oil on quality of hair based on subject questionnaire. 5.Global assessment for overall change in hair loss by the physician and subject. 6.Assessment of safety by observing episodes, severity and duration of any allergic reactions and adverse events. Timepoint: Day -3, Day 0, Day 15, Day 30, Day 45, Day 60 | — |
Countries
India
Contacts
Public ContactVandana Bade
Target Institute of Medical Education and Research
Outcome results
None listed