Study for hair and nail problems.
- Registration Number
- CTRI/2022/08/044667
- Lead Sponsor
- Transformative Learning Solutions Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
1.Female 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.Hair density of >100 and <200 hair follicle per square cm as per Trichoscan measurement.
6.Female 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).
7.Subjects with inferior and poor nail quality (cracked or brittle nails, vertical ridges, dark discolorations, yellow fingernails etc). Subjects with score less than 5 for nail health assessment.
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 having nail psoriasis or other conditions that requires
medical attention
4.Subjects with irreversible hair or nail conditions, due to which the
assessment is not possible
5.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.
6.Subjects who have history of alcoholism, smoking, crash dieting
and/ or psychiatric disorder including trichotillomania.
7.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.
8.Subjects who have nail problems due to fungal infections
9.Subjects who consume vitamins and food supplements that may
interfere with the study.
10.Subjects with poor nail quality due to fungal infection or subjects
with nail psoriasis will be excluded.
11.Subjects who wear wig or hair extensions
12.Subjects who wear nail extensions or nail jewellery
13.Subjects who disagree to not wear nail polish during the study
period
14.A known history or present condition of allergic response to any
pharmaceutical product/Ayurvedic/nutraceutical product and with any
trauma to nails
15.Subjects on oral medications, undergoing any chemical hair salon
treatment-straightening / perming / colour/ henna which will
compromise the study.
16.Subjects with chronic illness which may influence the study.
17.Subjects who are pregnant or lactating or nursing as established
with medical history
18.Menopausal female subjects as determined by medical history.
19.Subjects participating in other similar cosmetic or therapeutic trial
within last three months.
20.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. Change in hair growth rate, hair density, hair <br/ ><br>thickness, hair thinning. <br/ ><br>2. Reduction in hair fall. <br/ ><br>3. New hair growth. <br/ ><br>4. Improvement in scalp condition <br/ ><br>5. Improvement in smoothness <br/ ><br>6. Improvement in Shine/gloss <br/ ><br>7. Change in nail quality (cracked or brittle nails, <br/ ><br>vertical ridges, dark discolorations, yellow <br/ ><br>fingernails) and Moisture/hydration by <br/ ><br>dermatological visual assessment. <br/ ><br>8. Change in nail growth by length measurementTimepoint: Day1, Day 3, Day 32, Day 62 and Day 92
- Secondary Outcome Measures
Name Time Method The product safety profile by dermatologistTimepoint: Day1, Day 3, Day 32, Day 62 and Day 92