Hair oil study in evaluating increase in hair growth, hair volume.
- Registration Number
- CTRI/2023/05/052846
- Lead Sponsor
- Transformative Learning Solutions Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 33
1. Male and female subjects in general good health.
2. Subjects in the age group of 18-55 years (both 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 loss severity 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 –
dermatologist’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.
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 who consume vitamins and food supplements that may interfere with
the study.
7. Subjects who wear wig or hair extensions
8. Subjects on oral medications, undergoing any chemical hair salon treatment straightening / perming / colour/ 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 condition <br/ ><br>6. Improvement in hair thinningTimepoint: Day1, day 30 and day 60
- Secondary Outcome Measures
Name Time Method the product safety profile by dermatologistsTimepoint: Day1, day 30 and day 60