CTRI/2021/11/038154CompletedNot Applicable
To evaluate the Anti-grey efficacy of test regimen in healthy Indian human
Unilever Industries Pvt Ltd1 site in 1 country180 target enrollmentStarted: October 25, 2021Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Significant improvement in Grey hair condition by expert/dermatologist assessment
Study Overview
Brief Summary
Study will be conducted to assess the efficacy of test product in imparting Grey hair benefits. After consenting and qualifying the inclusion and exclusion criteria subjects will be enrolled into the study. Post baseline assessments, test product will be dispensed to subjects as per randomization and subjects will be instructed to use the product thrice a week and evaluation assessments will be done at different times points over a period of 5 months.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 42.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Female and male subjects in the ratio of 2:1 in general good health.
- •2.Subjects in the age group 18-42 years (both the ages inclusive).
- •3.Subjects willing to give a written informed consent and agree to come for a regular follow up visit.
- •4.Subjects willing to apply TP as per instruction and they will not use any other hair product during the study period 5.Subjects willing to abide by and comply with the study protocol.
- •6.Subjects who have not participated in a similar investigation in the past three months.
- •7.Subjects who agree to refrain from using hair dye / hair colour /henna during the study period.
- •8.Subjects willing to refrain from any type of hair treatment like perming, straightening etc.
- •during the study duration.
Exclusion Criteria
- •1.Subjects who have undergone hair growth treatment within 3 months before screening into the study.
- •2.Subject who are currently using henna.
- •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 (females) who are pregnant or lactating 5.Subjects who have had hair transplant.
- •6.A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
- •7.Chronic illness which may influence the cutaneous state.
- •8.Subjects participating in other similar cosmetic or therapeutic trial within last three months 9.Subjects who have history of alcoholism, smoking and/ or psychiatric disorder including trichotillomania.
- •10.Menopausal female subjects as determined by medical history 11.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.
- •12.Subjects having allergic reaction for oil.
Outcomes
Primary Outcomes
Significant improvement in Grey hair condition by expert/dermatologist assessment
Time Frame: 4 Months product and 1 Month regression
Secondary Outcomes
- Significant reduction and prevention in reoccurence of Grey hair condition by expert/dermatologist assessment(4 Months product and 1 Month regression)
Investigators
Study Sites (1)
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