None listed
Conditions
Interventions
Intervention1: Dheedhi Anti hair fall herbal Shampoo: Dheedhi Anti hair fall herbal Shampoo
Control Intervention1: Market comparator herbal Anti-Hair fall shampoo: Market comparator herbal Anti-Hair f
Sponsors
Dhathri Ayurveda Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Willingness to give written informed consent Subjects in the range of 18-50 years of age Subjects with very less to severe Hair fall. Willingness to discontinue any hair care product other than the IP throughout the study. Subjects who are not willing to color their hair throughout the treatment period Subjects willing to stop all the hair treatment such as hair spa, straightening, curling, perming, etc. Subjects with no skin allergies to any cosmetic products Willingness to follow the protocol requirements as evidenced by written informed consent Comprehension of the nature and purpose of the study and compliance with the requirement of the entire procedure In addition, female subjects selected for the study must be able to use a medically acceptable form of birth control during the study or be surgically sterile or be post-menopausal for at least 1 year.
Exclusion criteria
Exclusion criteria: 1. Subjects with known hypersensitivity to any specific ingredients of IPs 2. Subjects below the age of 18 years and subjects above 50 years 3. Subjects not willing to participate in the study 4. Subjects who have previously undergone hair transplantation procedures 5. Subjects with any skin diseases. 6. Subjects are being treated for hair fall or severe active infection of any type previously 7. Presence of any underlying significant uncontrolled medical illness involving the cardiovascular, respiratory, renal, gastrointestinal, hepatic, immunologic, hematological,endocrine, or nervous system s or psychiatric disease, HIV 8. Subjects with pre-existing scalp disorder such as scalp psoriasis, lichen planus, lichen planopilaris, DLE Discoid lupus erythematosus , sebopsoriasis will be excluded from the study 9. A female subject who is breast-feeding, pregnant, or intends to become pregnant during the study 10. Participating in a clinical research trial within 30 days prior to screening 11. Subjects who are cognitively impaired and/or who are unable to give informed consent. 12. Any other health or mental condition that in the Investigatorâ??s opinion may adversely affect the ability to complete the study or its measures or that may pose significant risk to the subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scales to rate over all experience of the study product with respect to the following 1) Hair fall Reduction 2) Hair damage control 3) New hair growth promotion 4) Cooling effect on scalp 5) Moisture maintenance 6) Management of Alopecia Timepoint: Visit 1 Day1 Visit 2 Day7 Visit 3 Day14 Visit 4 Day21 Visit 5 Day28 Visit 6 Day35 Visit 7 Day42 | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS Scales to rate over all experience of the study product with respect to the following: 1. Mildness 2. Non-irritant 3. Management of Seborrhea dermatitis 4. Texture of hair Timepoint: visit 7 Day42 | — |
Countries
India
Contacts
Public ContactPreeti A
Dhathri Ayurveda Pvt Ltd
Outcome results
None listed