Clinical Study of Dabur VatikaNilibringhadi Gold Hair GrowthOil in Comparison to a MarketedComparator and â??No Treatmentâ??arm in healthy Human Volunteers
- Registration Number
- CTRI/2020/02/023127
- Lead Sponsor
- Dabur India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 111
1) Male and female subjectsâ?? 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 & female Subjects falling under Grade 3 - Grade 6 of hair loss severity grade evaluated as per photo numerical10 point scale
(Linear scale for assessment purpose-In use Scale).
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 judgment.
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 which will compromise the study.
8) Subjects who are pregnant or lactating or nursing as established with medical history
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Assessment of change in hair length <br/ ><br>2) Assessment of change in hair growth rateTimepoint: 2, 4 & 6 weeks
- Secondary Outcome Measures
Name Time Method 1) Assessment of change in hair density <br/ ><br>2) Assessment of change in anagen and telogen ratio <br/ ><br>3) Assessment of change in density of vellus hair & terminal hair <br/ ><br>4) Assessment of change in hair thickness and hair fall <br/ ><br>5) Assessment of change in hair thinning by dermatologists <br/ ><br>6) Assessment of overall safety of test productTimepoint: 2, 4 & 6 weeks