Health Condition 1: L659- Nonscarring hair loss, unspecified
Conditions
Interventions
None listed
Sponsors
Med Pharma CRO
NYA HEALTHAYU INTERNATIONAL
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subjectsââ?¬• in general good health. 2. Subjects in the age group 18-65 years (both the ages inclusive). 3. Subjects willing to give a written informed consent and agree to come for a regular follow up visit. 4. Subjects willing to abide by and comply with the study protocol. 5. Subjects who have not participated in a similar investigation in the past three months. 6. Subjects complaining of hair fall and damage. 7. Healthy volunteers with no known allergy as established by medical history. 8. Subjects who do not smoke or drink 9. Subjects who are not crash dieting. 10. Subjects who agree to refrain from using hair dye / hair colour during the study period. 11. Subjects willing to refrain from any type of hair treatment like perming, straightening etc. during the study duration. 12. Subjects who are willing to refrain from any other oil treatment/hair spa and oral medications for hair growth during the study.
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 such as scalp Psoriasis which may interfere in the study- dermatologistââ?¬•s judgments. 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 and/ or psychiatric disorder. 5. Subjects who have had hair transplant. 6. Subjects who take pharmaceutical product which cause hirsutism (ex. phenytoin) and finesteride for androgenic alopecia. 7. Subjects with a known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products. 8. Subjects consuming alcohol and smoking. 9. Subjects on oral medications such as vitamin supplements, including multi-vitamins which will compromise the study. 10. Subjects who are pregnant or lactating or nursing as established with medical history 11. Subjects under medical treatment for hair problems, prescription drugs such as Minoxidil, Finasteride, or any 5 Ã?±-reductase inhibitor or light therapy. 12. Subjects undergoing any chemical hair salon treatment-straightening / perming / colour 13. Subjects with chronic illness which may influence the cutaneous state. 14. Subjects participating in other similar cosmetic or therapeutic trial within last three months. 15. Subjects with medical history of thyroid disorders. 16. 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. 17. Subjects who have experienced a known stressful event within the last 6 months such as death in family, miscarriage etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the effectiveness of Ayurvedic NEEM AYU Anti Hairfall Kit (NEEM AYU Hair Care Capsule, NEEM AYU Anti Hairfall Taila, NEEM AYU Anti Hairfall Medicated Shampoo) in the management of hair fall / hair loss. 1.Clinical Assessment - Improvement 2.60 Second Hair Count Test - Reduction in hair loss 3.Pull test - Reduction in hair loss 4.QOL questionnaire - Improvement in QOL Baseline data will be compared after 60 days of treatmentTimepoint: To determine the effectiveness of Ayurvedic NEEM AYU Anti Hairfall Kit (NEEM AYU Hair Care Capsule, NEEM AYU Anti Hairfall Taila, NEEM AYU Anti Hairfall Medicated Shampoo) in the management of hair fall / hair loss. 1.Clinical Assessment - Improvement 2.60 Second Hair Count Test - Reduction in hair loss 3.Pull test - Reduction in hair loss 4.QOL questionnaire - Improvement in QOL Baseline (0 Day) to End of study (60 Day) | — |
Secondary
| Measure | Time frame |
|---|---|
| No incidence of Adverse events (AE) and Serious Adverse Events (SAE) during the study period. Baseline data will be compared after 60 days of treatmentTimepoint: Baseline (0 Day) to End of study (60 Day) | — |
Countries
India
Contacts
Public ContactDr Parikshit Debnath
Aktriana Pvt. Ltd.
Outcome results
None listed