A study to evaluate the efficacy of test product in hair fall benefits
- Registration Number
- CTRI/2020/03/023682
- Lead Sponsor
- Diabliss Consumer Products Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
1.Male and female adult subjects in general good health as determined from a recent medical history, general physical examination, dermatological assessment.
2.Subjects in the age group of 35-50 years (both ages inclusive).
3.Subjects complaining of hair fall and damage.
4.Hair density measurement between 150-250 hair follicle per square cm as per Trichoscan measurement.
5.Male & female subjects falling under Grade 3 - Grade 6 of hair loss severity grade evaluated as per photo numerical 10-point scale (Linear scale for assessment purpose-In use Scale).
6.Subjects with normal thyroid range.
7.Subjects who agrees not to use any other product/treatment/home remedy for hair except the provided product during the study period.
8.Subjects willing to refrain from any type of hair treatment like perming, straightening etc. during the study duration.
9.Subjects who agree to refrain from using hair dye / hair colour during the study period.
10.Subjects who are willing to refrain from any other oil treatment/hair spa and oral medications for hair growth during the study.
11.Subjects willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up.
12.Subjects willing to abide by and comply with the study protocol.
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 ââ?¬â?? dermatologistââ?¬•s judgement.
3.Subjects who are anaemic (based on RBC count).
4.Subjects who smoke or drink.
5.Subjects who are on crash dieting.
6.Subjects on oral medications such as vitamin supplements, including multi-vitamins which will compromise the study.
7.Subjects under medical treatment for hair problems, prescription drugs such as Minoxidil, Finasteride, or any 5 �±-reductase inhibitor or light therapy.
8.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.
9.Subjects who have history of alcoholism, smoking, crash dieting and/ or psychiatric disorder including trichotillomania.
10.Subjects who have had hair transplant, who have taken pharmaceutical product which cause hirsutism (ex. phenytoin) and finesteride for androgenic alopecia, under medical treatment for hair problems.
11.A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
12.Subjects on oral medications, undergoing any chemical hair salon treatment-straightening / perming / colour which will compromise the study.
13.Subjects who are pregnant or lactating or nursing as established with medical history.
14.Menopausal female subjects as determined by medical history.
15.Subjects with chronic illness which may influence the cutaneous state.
16.Subjects participating in other similar cosmetic or therapeutic trial within last three months.
17.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 1.Significant improvement in hair growth rate and hair density. <br/ ><br>2.Significant improvement in hair thickness. <br/ ><br>3.Significant improvement in hair strength. <br/ ><br>4.Significant reduction in hair fall count. <br/ ><br>5.Significant reduction in hair fall. <br/ ><br>6.Significant improvement in hair thinning. <br/ ><br>7.Significant improvement in hair quality. <br/ ><br>Timepoint: At week 6 & Week 16 in comparison to baseline. <br/ ><br>
- Secondary Outcome Measures
Name Time Method To evaluate the product safety by dermatologist assessment.Timepoint: Approximately 122 days for each subject