A Prospective study to evaluate the Safety and Efficacy of Investigational Hair crÃ¨me in comparison with coconut oil in subjects with mild to severe Hair fall.

Dhathri Ayurveda Pvt Ltd0 个研究点目标入组 40 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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

•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
•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

发起方

Dhathri Ayurveda Pvt Ltd