An efficacy evaluation of Dabur Oil formulation for hair fall reduction, strengthening of hair and overall improvement in hair & scalp condition in healthy Indian human subjects
- Registration Number
- CTRI/2014/06/004681
- Lead Sponsor
- Dabur India Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
•Male and Female subjects in general good health.
•Subjects in the age group 18-65 years (both the ages inclusive).
•Subjects willing to give a written informed consent and agree to come for a regular follow up visit.
•Female Subjects falling under Grade 2 - Grade 6 of hair loss severity grade evaluated as per standard photonumeric 6 point scale.
•Male subjects falling under Grade 3â?? Grade 6 of hair loss severity grade evaluated as per Norwood scale.
•Subjects willing to abide by and comply with the study protocol.
•Subjects who have not participated in a similar investigation in the past two weeks.
•Subjects complaining of hair fall and damage
•Healthy volunteers with no known allergy to any of the test ingredients as established by medical history.
•Subjects who show no sensitivity to test product.
•Subjects who are not on crash dieting.
•Subjects who agree not to change the brand of currently used hair colour, dye, treatment etc., if any during the study term.
•Subjects willing to refrain from any type of hair treatment like head massage, oil application (on scalp), perming, etc. during the study duration.
•Subjects who are undergoing hair growth treatment within 3 months before screening into the study.
•Subjects having any active scalp disease which may interfere in the study.
•Subjects who have treatments of cancer chemotherapy last 6 months before starting study or have a plan to do treatments of them during study terms.
•Subjects who have history of alcoholism and/ or psychiatric disorder including trichotillomania.
•Subjects who have had hair transplant.
•Subjects who take pharmaceutical product which cause hirsutism.
•A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
•Subjects on oral medications which will compromise the study.
•Subjects who are pregnant lactating or nursing as established with medical history.
•Chronic illness which may influence the cutaneous state.
•Subjects participating in other similar cosmetic or therapeutic trial within last two weeks
•Any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anaemia, 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?¢To evaluate the efficacy of Dabur hair oil formulation in hair fall reduction strengthening of hair and overall improvement in hair & scalp condition in comparison to baseline. <br/ ><br>â?¢To evaluate the efficacy of Dabur Hair Oil formulation in hair fall reduction strengthening of hair and overall improvement in hair and scalp condition in comparison to marketed hair oil groups. <br/ ><br>Timepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method â?¢Safety of Investigational product by assessment of site application reaction by dermatologist and subjects.Timepoint: 12 weeks