To study the Safety and Efficacy of Investigational Hair oil in comparison with coconut oil and comparator Hair oil in subjects with mild to severe Hair fall
- Conditions
- Health Condition 1: L63- Alopecia areata
- Registration Number
- CTRI/2020/04/024824
- Lead Sponsor
- Thai Herbals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Willingness to give written informed consent
2.Subjects with mild to severe hair fall. (Severe -50 percent, moderate-30 percent,mild- 20 percent)
3.Subjects with no skin allergies to any cosmetic products
4.Willingness to discontinue any hair care product other than the IP throughout the study.
5.Subjects who is not willing to color their hair throughout the treatment period
6.Subjects willing to discontinue all the hair care treatments such as hair spa,straightening, curling, hair perming, etc. throughout the treatment period
7.Willingness to follow the protocol requirements as evidenced by written
informed consent
8.Comprehension of the nature and purpose of the study and compliance with the requirement of the entire procedure
9.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 IPâ??s
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 other skin diseases.
6.Subjects are being treated for hair fall or severe active infection of any type.
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 1.Hair fall Reduction <br/ ><br>2.Hair growth stimulation <br/ ><br>3.Growth of existing hair <br/ ><br>4.New hair growth <br/ ><br>5.Hair damage protection <br/ ><br>6.Shine and health of hair <br/ ><br>7.Cooling effect <br/ ><br>8.Dandruff control <br/ ><br>Timepoint: Visit1 day1 <br/ ><br>Visit2 day7 <br/ ><br>Viist3 day10 <br/ ><br>Visit4 day15 <br/ ><br>Visit5 day21 <br/ ><br>Visit6 day28 <br/ ><br>Visit7 day42
- Secondary Outcome Measures
Name Time Method 1.Visible hair fall reduction <br/ ><br>2.Hair growth improvement -length and thickness <br/ ><br> <br/ ><br>3.Reduction of hair damage -split ends and breakages <br/ ><br> <br/ ><br>4.Improvements in hair strength and elasticity of hair <br/ ><br>5. Texture and appearance softness, smoothness and shine <br/ ><br> <br/ ><br>6.Scalp itching and dandruff <br/ ><br> <br/ ><br>7.Product lightness and non-stickiness <br/ ><br> <br/ ><br>8.Feedback on product smell and smell retention on hair <br/ ><br>Timepoint: Visit7 day 42