None listed
Conditions
Interventions
None listed
Sponsors
Kerala Ayurveda Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Indian male/female volunteer aged between 25-50 years (both inclusive) from different cities. 1. Subjects willing to give Informed Consent Form. 2. Subjects willing to complete the study assessments/questionnaires. 3. Fitzpatrick Skin Type I V. 4. Minimal to moderate Allergen Skin Roughness Scale. 5. Subjects diagnosed with mild to moderate acne vulgaris based on the Global Acne Grading System (GAGS) score. 6. Stable vitals and no major systemic illness affecting metabolism or skin health. 7. Controlled Hypertension and RBS. 8. Willing to avoid usage of his/her own face serum and cream for at least one week before commencement and during this study. 9. Subjects having acne prone skin
Exclusion criteria
Exclusion criteria: 1. Subjects with preexisting severe systemic disease necessitating longterm medication 2. Subjects with mild to severe anaphylaxis reactions to turmeric, dairy or related substances 3. Evidence of significant uncontrolled comorbid disease like 4. Type 1 or Type 2 Diabetes Mellitus or uncontrolled blood sugar levels RBS greater than 140 mg/dL at baseline 5. History of dyslipidemia or metabolic syndrome 6. Diagnosed PCOS polycystic ovarian syndrome, thyroid disorders, or other hormonal imbalances 7. GAGS score greater than 30 severe acne with deep nodulocystic lesions or acne conglobata 8. Presence of active dermatitis, eczema, psoriasis, or rosacea 9. Hyperpigmentation disorders like melasma, vitiligo, etc 10. Pregnancy or breast feeding. 11. Participants using oral or topical turmeric supplementation within 4 to 6 weeks 12. Patients with recent skin treatment like use of systemic retinoids, use of topical retinoids, steroids, or antibiotics and undergoing chemical peels, laser therapy, or microneedling for acne within the past 6 months 13. History of cancer including solid tumors, hematologic malignancies and carcinoma in situ 14. Any neurological congenital or acquired, vascular or systemic disorder which could affect any of the efficacy assessments 15. Participation in the current or previous clinical trial with any approved or investigational products during the past 1 month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage Improvement in skin brightening and skin hydration (Twak Prasannata) using instrument corneometer and Allergan Skin Roughness Scale from baseline (Visit 1, Day 0) to study completion (Visit 4, Day 60). 2. Percentage reduction of Trans Epidermal water loss using Tewameter instrument. 3. Percentage Reduction in Mukha Dushti Lakshana (facial skin issues) using Global Acne Grading System (GAGS) score from baseline to study completion. 4. Effectiveness in managing signs of aging (Vayahsthapana) using Wrinkle Severity Rating Scale (WSRS) from baseline to day 60.Timepoint: Day 0 day 30 and Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage improvement in Immunity (Ojas) Evaluated using the Immune Status Questionnaire (ISQ) scale. 2. No significant deviations in hematology (CBC), biochemistry (LFT, RFT, Lipid Profile), and RBS levels at baseline and Visit 4. 3. Monitoring of adverse events (AEs) at each follow-up visit (Visit 2, 3, and 4). Timepoint: Day 0 day 30 and Day 60 | — |
Countries
India
Contacts
Public ContactDrSukrutha S
Kerala Ayurveda Ltd
Outcome results
None listed