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Study for hair and nail problems.

Clinical study to evaluate the efficacy and safety of Nail n Mane in healthy adult female volunteers with hair and nail problems or concerns.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/044667
Enrollment
40
Registered
2022-08-05
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Nail n Mane Capsule: 1 capsule daily for oral consumption after breakfast for 12 weeks Control Intervention1: None: NA

Sponsors

Transformative Learning Solutions Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
1. Change in hair growth rate, hair density, hair thickness, hair thinning. 2. Reduction in hair fall. 3. New hair growth. 4. Improvement in scalp condition 5. Improvement in smoothness 6. Improvement in Shine/gloss 7. Change in nail quality (cracked or brittle nails, vertical ridges, dark discolorations, yellow fingernails) and Moisture/hydration by dermatological visual assessment. 8. Change in nail growth by length measurementTimepoint: Day1, Day 3, Day 32, Day 62 and Day 92

Secondary

MeasureTime frame
The product safety profile by dermatologistTimepoint: Day1, Day 3, Day 32, Day 62 and Day 92

Countries

India

Contacts

Public ContactSudhanthiran S

Transformative Learning Solution Pvt. Ltd.

satyendra.kumar@transformative.in9891253516

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026