Study to check the improvement in hair health.
- Registration Number
- CTRI/2022/11/047219
- Lead Sponsor
- Transformative Learning Solutions Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1.Female and Male subjects in general good health.
2.Subjects in the age group 18-55 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.Subjects falling under Grade 3 - Grade 6 of hair lossseverity grade evaluated as per MSCR photo numerical 10-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 judgement.
3.Subjects who have undergone 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. Subjects taking food or vitamin supplements that may compromise the study
7.Subjects who wear wig or hair extensions
8.Subjects on oral medications, undergoing any chemical hair salon treatment-straightening / perming / color/ henna which will compromise the study.
9.Subjects with chronic illness which may influence the study.
10.Subjects who are pregnant or lactating or nursing as established with medical history
11.Menopausal female subjects as determined by medical history.
12.Subjects participating in other similar cosmetic or therapeutic trial within last three months.
13.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. Improvement in hair volume <br/ ><br>2. Improvement in hair softness <br/ ><br>3. Improvement in hair strength <br/ ><br>4. Reduction in hair fall <br/ ><br>5. Improvement in scalp conditionTimepoint: Day1, Day 30 and Day 60
- Secondary Outcome Measures
Name Time Method The product safety profile by dermatologistTimepoint: Day1, Day 30 and Day 60