None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Healthy lactating female subjects with age between 20 and 40 years (both inclusive at the time of consent). 2. Participants complaining about having at least 50 to 100 hair fall per day. 3. Participants with 50 counts of hair fall from hair combing method (60-sec hair count). 4. Participants having good general health as determined by the Investigator on the basis of medical history and vital signs. 5. Participants of childbearing potential must have a negative urine pregnancy test performed at screening visit.
Exclusion criteria
Exclusion criteria: 1. Participants with clinical diagnosis of hair loss disorder such as alopecia areata or scarring forms of alopecia. 2. Participants with hair loss due to Autoimmune disorder/ Chemotherapy/ immunosuppressive drugs. 3. Participants with history of surgical correction of hair loss on the scalp. 4. Participants with history of any dermatological condition (like psoriasis or infections) of the scalp other than hair loss OR with any active scalp disease which may interfere in the study. 5. Participants with current hair loss or skin disease (e.g., psoriasis, atopic dermatitis, skin cancer, sun damage, seborrheic dermatitis), infections, cuts, and/or abrasions on the scalp or condition (e.g., sunburn, tattoo) on the treatment area, that in the opinion of the investigator, might put the participant at risk or interfere with the study conduct or evaluations. 6. Participants with a history of chronic health conditions (eg, diabetes, hypertension, chronic renal failure, heart and liver disease), endocrine abnormalities including stable thyroid disease, psychiatric illness, bariatric surgery/eating disorders such as bulimia or binge eating, cardiovascular surgery, or history of any other major surgery. 7. Participants with the history of malignancy OR known history of autoimmune thyroid disease, any other thyroid disorder/abnormality or other autoimmune disorders. 8. Participants with known allergy or sensitivity to cosmetic products and/or any ingredients of the test product. 9. Participants who had undergone chemotherapy or radiation within the last 2 years. 10. Participants who have started using hormones for birth control or hormone replacement therapy within the last 6 months. 11. Participants who have undergone hair regrowth treatments (minoxidil, finasteride, PRP, etc.) within 6 months before screening. 12. Participants who using any products/devices aimed to promote scalp hair growth within the 6 months prior to study initiation. 13. Participants who have applied topical treatment for hair loss for at least 4 weeks and any systemic treatment for at least 3 months, prior to their participation in the study. 14. Participants with a history or presence of significant alcoholism or drug abuse and smoking or consumption of tobacco products. 15. Any other condition which could warrant exclusion from the study, as per the investigator s discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical assessment of hair fall and Instrumental assessment of Hair thickness and Hair growth rateTimepoint: Day 00, Day 45 and Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical assessment of anagen and telogen ratio (A:T ratio), hair strength, hair and scalp related parametersTimepoint: Day 00, Day 45 and Day 90;Instrumental assessment of hair density and Vellus & terminal hair count.Timepoint: Day 00, Day 45 and Day 90;Laboratory assessments of hormonal and nutritional blood markersTimepoint: Day 00 and Day 90;Participant Evaluation QuestionnaireTimepoint: Day 45 and Day 90 | — |
Countries
India
Contacts
Cliantha Research