the study Safety and Efficacy of Anti-Hair fall shampoo in comparison with Comparator Anti-Hair fall shampoo in subjects with very less to severe Hair fall
- Registration Number
- CTRI/2018/06/014444
- Lead Sponsor
- Dhathri Ayurveda Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Scales to rate over all experience of the study product with respect to the following <br/ ><br>1)Hair fall Reduction <br/ ><br>2)Hair damage control <br/ ><br>3)New hair growth promotion <br/ ><br>4)Cooling effect on scalp <br/ ><br>5)Moisture maintenance <br/ ><br>6)Management of Alopecia <br/ ><br>Timepoint: Visit 1 Day1 <br/ ><br>Visit 2 Day7 <br/ ><br>Visit 3 Day14 <br/ ><br>Visit 4 Day21 <br/ ><br>Visit 5 Day28 <br/ ><br>Visit 6 Day35 <br/ ><br>Visit 7 Day42
- Secondary Outcome Measures
Name Time Method VAS Scales to rate over all experience of the study product with respect to the following: <br/ ><br>1.Mildness <br/ ><br>2.Non-irritant <br/ ><br>3.Management of Seborrhea dermatitis <br/ ><br>4.Texture of hair <br/ ><br>Timepoint: visit 7 Day42