CTRI/2018/06/014418
Completed
Phase 4
A Prospective study to evaluate the Safety and Efficacy of Investigational Hair crème in comparison with coconut oil in subjects with mild to severe Hair fall.
Dhathri Ayurveda Pvt Ltd0 sites40 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Dhathri Ayurveda Pvt Ltd
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Willingness to give written informed consent
- •2\. Subjects in the range of 18\-50 years of age
- •3\. Subjects with mild to severe Hair fall. Severe\-50 percent, Moderate\-30 percent, Mild\-20 percent.
- •4\. Subjects with no skin allergies to any cosmetic products
- •5\. Willingness to discontinue any hair care product other than the IP throughout the study.
- •6\. Subjects who are willing not to color their hair throughout the treatment period
- •7\. Subjects willing to stop all the hair treatment such as hair spa, straightening, curling, perming, etc. throughout the treatment period
- •8\. Willingness to follow the protocol requirements as evidenced by written informed consent
- •9\. Comprehension of the nature and purpose of the study and compliance with the requirement of the entire procedure
- •10\. 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
- •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 systems 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
Outcomes
Primary Outcomes
Not specified
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