Study for hair growth and hair fall
- Conditions
- Health Condition 1: L659- Nonscarring hair loss, unspecified
- Registration Number
- CTRI/2022/09/045239
- Lead Sponsor
- Monkey Creations Inc MCI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 54
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 <225 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 photo numerical10
point scale (Linear scale for assessment purpose-MSCR
Scale).
1. Subjects who have undergone hair growth treatment within
6 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 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 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. A known history or present condition of allergic
response/hypersensitivity to any cosmetic ingredients and
pharmaceutical products.
7. Subjects on oral medications, undergoing any chemical hair salon treatment-straightening / perming / colour which will compromise the study.
8. Subjects who are pregnant or lactating or nursing as
established with medical history
9. Menopausal female subjects as determined by medical
history.
10. Subjects with chronic illness which may influence the
cutaneous state.
11. Subjects taking food or vitamin supplements that may
comprise the study
12. A known history or present condition of allergic response to
any pharmaceutical product/Ayurvedic/nutraceutical product
13. Subjects participating in other similar cosmetic or
therapeutic trial within last three months.
14. 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 <br/ ><br>2. Significant improvement in hair density <br/ ><br>3. Significant improvement in hair strength <br/ ><br>4. Significant reduction in hair fall with or without bulb <br/ ><br>5. Improvement in new hair growth <br/ ><br>6. Significant improvement in hair thinning <br/ ><br>7. Significant improvement in hair qualityTimepoint: 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