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Clinical Study of Dabur VatikaNilibringhadi Gold Hair GrowthOil in Comparison to a MarketedComparator and â??No Treatmentâ??arm in healthy Human Volunteers

Not Applicable
Completed
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
Inclusion Criteria

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).

Exclusion Criteria

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
NameTimeMethod
1) Assessment of change in hair length <br/ ><br>2) Assessment of change in hair growth rateTimepoint: 2, 4 & 6 weeks
Secondary Outcome Measures
NameTimeMethod
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
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