Health Condition 1: L219- Seborrheic dermatitis, unspecified
Conditions
Interventions
None listed
Sponsors
Med Pharma CRO
NYA HEALTHAYU INTERNATIONAL
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female subjects in the age group of 18 years to 65 years. 2.Subjects suffering from Seborrheic dermatitis (dandruff) with following symptoms -Noticeable scaling of the scalp, Irritation of the scalp, Itchiness of the scalp, Greasiness of the scalp. 3.Participants read and understood the PIS and given written informed consent. 4.Participants are fit and no need for any hospital administration. 5.Agree to follow instruction of doââ?¬•s and donââ?¬•ts in regular daily lifestyle. 6.Subjects willing to perform all study related procedures including the use of NEEM AYU Anti Dandruff Capsule, NEEM AYU Anti Dandruff Hair Oil and NEEM AYU Anti Dandruff Shampoo. 7.Allow the physical and other tests and willing to document symptoms and medication. 8.Subjects/ volunteers/ study participants {and /or legally accepted representative (LAR)} willing to give written informed consent and ability to adhere to dosing and visit schedules and meet study requirements.
Exclusion criteria
Exclusion criteria: 1.History or present illness of COVID-19 2.If any of the participants suffered from the following they were excluded: Psoriasis, Atopic or irritant contact dermatitis, Tinea capitis, Immunodeficiency, Known HIV-positive, Known Hepatitis B or C positive, Parkinsonââ?¬•s Disease. 3.If a female is pregnant or lactating she will be excluded. 4.Patients who had used within 1 month prior to baseline any treatment that would affect the results of the trial, including: systemic antifungal, systemic steroids, systemic antibiotics, systemic anti-inflammatory agents, cytostatic or immune-modulating drugs (e.g. cyclosporine, tacrolimus, pimecrolimus), topical steroids, topical retinoids, topical anti-inflammatory agents, topical antibiotics, topical treatment of adherent dandruff (e.g., coal tar preparations, antidandruff shampoos/ oils/ gels/ creams/ conditioners, antihistamines. 5.Chronic & acute disorders requiring hospital admission. 6.Volunteers/ study participants unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study. 7.Inability to carry out visits for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the effectiveness of NEEM AYU Anti Dandruff Capsule, NEEM AYU Anti Dandruff Hair Oil and NEEM AYU Anti Dandruff Shampoo in the management of dandruff. 1.Clinical assessment - Improvement 2.The IGA for pruritus score - Reduction 3.The dermatological assessment form for application site reaction (dryness, scaliness, oiliness) - Reduction 4.Excoriation pruritus grading (EPG) - Reduction 5.Adherent Scalp Flaking Score (ASFS) - Reduction 6.Redness of Scalp Skin - Reduction 7.Grading of scalp skin involvement - Reduction 8.Dermatology Life Quality Index (DLQI) - ImprovementTimepoint: 1. Clinical assessment 2. The IGA for pruritus score 3. The dermatological assessment form for application site reaction (dryness, scaliness, oiliness) 4. Excoriation pruritus grading (EPG) 5. Adherent Scalp Flaking Score (ASFS) 6. Redness of Scalp Skin 7. Grading of scalp skin involvement 8. Dermatology Life Quality Index (DLQI) Baseline (0 Day) to End of study (45 Day) | — |
Secondary
| Measure | Time frame |
|---|---|
| No incidence of Adverse events (AE) and Serious Adverse Events (SAE) during the study periodTimepoint: Baseline (0 Day) to End of study (45 Day) | — |
Countries
India
Contacts
Public ContactDr Parikshit Debnath
Aktriana Pvt. Ltd.
Outcome results
None listed