To evaluate the Safety and Efficacy of Investigational Hair creme in comparison with coconut oil in subjects with mild to severe Hair fall
- Registration Number
- CTRI/2018/06/014418
- Lead Sponsor
- Dhathri Ayurveda Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
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
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 Growth Stimulation <br/ ><br>â?¢Growth of Existing Hair <br/ ><br>â?¢New Hair Growth <br/ ><br>2)Hair Fall Reduction <br/ ><br>3)Preservation Of Natural Hair Color <br/ ><br>4)Hair Damage Protection <br/ ><br>5)Shine and Health Of Hair <br/ ><br>6)Dandruff ControlTimepoint: 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(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.Hair fall reduction <br/ ><br>2.Hair growth improvement (length & thickness) <br/ ><br>3.Reduction of hair damage (split ends, breakages) <br/ ><br>4.Improvements in hair color <br/ ><br>5.Scalp Cooling & Sleep Pattern <br/ ><br>6.Hair Strength & Elasticity <br/ ><br>7.Texture And Appearance of hair (softness, smoothness, shine) <br/ ><br>8.Scalp Itching & dandruff <br/ ><br>9.Non Stickiness And Ease Of Use <br/ ><br>Timepoint: Visit 6(Day42)