Evaluation of Dabur Ayurvedic Oils for hair growth and hair fall reduction in healthy adult volunteers
- Registration Number
- CTRI/2021/04/033010
- Lead Sponsor
- Dabur India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1)Subjects in general good health.
2)Subjects in the age group 18-45 years (both the ages inclusive).
3)Subjects complaining of hair fall and damage.
4)Subjects willing to give a written informed consent and willing to abide by and comply with the study protocol.
5)Hair density of >100 and <200 hair follicle per square cm as per Trichoscan measurement
6)Male and Female Subjects falling under Grade 3 - Grade 6 of hair loss severity grade evaluated as per MSCR photo numerical 10-point scale (Linear scale for assessment purpose-In Use Scale).
7)Subjects with mild or moderate dandruff condition based on the total adherent and non adherent score.
8)The subjects who agree to refrain from using hair dye / hair colour during the study period.
1)Subjects who have undergone hair growth treatment within 3 months before screening into the study.
2)Subjects having any active scalp disease which may interfere in the study â?? dermatologistâ??s judgement.
3)Subjects who have taken chemotherapy for cancer in the 6 months prior to start of the study or have a plan to do treatments during study.
4)Subjects who have history of alcoholism, smoking, crash dieting and/ or psychiatric disorder including trichotillomania.
5)Subjects who have had hair transplant, who have taken pharmaceutical product which cause hirsutism (ex. phenytoin) and finasteride for androgenic alopecia, under medical treatment for hair problems.
6)A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
7)Subjects on oral medications, undergoing any chemical hair salon treatment-straightening / perming / colour/ henna which will compromise the study.
8)Subjects with chronic illness which may influence the cutaneous state.
9)Subjects who are pregnant or lactating or nursing as established with medical history
10)Menopausal female subjects as determined by medical history.
11)Subjects participating in other similar cosmetic or therapeutic trial within last three months.
12)Subjects with any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.
1)Subjects who have undergone hair growth treatment within 3 months before screening into the study.
2)Subjects having any active scalp disease which may interfere in the study â?? dermatologistâ??s judgement.
3)Subjects who have taken chemotherapy for cancer in the 6 months prior to start of the study or have a plan to do treatments during study.
4)Subjects who have history of alcoholism, smoking, crash dieting and/ or psychiatric disorder including trichotillomania.
5)Subjects who have had hair transplant, who have taken pharmaceutical product which cause hirsutism (ex. phenytoin) and finasteride for androgenic alopecia, under medical treatment for hair problems.
6)A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
7)Subjects on oral medications, undergoing any chemical hair salon treatment-straightening / perming / colour/ henna which will compromise the study.
8)Subjects with chronic illness which may influence the cutaneous state.
9)Subjects who are pregnant or lactating or nursing as established with medical history
10)Menopausal female subjects as determined by medical history.
11)Subjects participating in other similar cosmetic or therapeutic trial within last three months.
12)Subjects with any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Significant improvement in hair growth rate. <br/ ><br>â?¢Significant improvement in hair density <br/ ><br>â?¢Significant improvement in hair thickness <br/ ><br>â?¢Significant reduction in hair fall <br/ ><br>â?¢Significant decrease in hair thinning <br/ ><br>â?¢Significant reduction in adherent and non adherent dandruff <br/ ><br>â?¢Significant improvement in scalp and hair condition. <br/ ><br>â?¢Significant improvement in hair length <br/ ><br>â?¢Significant/ faster absorption in scalp <br/ ><br>â?¢Maintenance of existing hair color <br/ ><br>Timepoint: Shaving and assessment on day 1, Day 15, day30 and Day 60. <br/ ><br>Follwed by assessment on day 3, day 17, day 32 and day 62.
- Secondary Outcome Measures
Name Time Method Dermatological safety assessmentTimepoint: day 1, Day 3, day 15, day 17, day 30, Day 32, day 60 and day 62