None listed
Conditions
Interventions
Intervention1: NR-INF-IB-01@250 mg Capsules: Subjects will receive 2 capsules once daily for 8 weeks
Control Intervention1: NR-INF-IB-02@500 mg Capsules: Subjects will receive 2 capsules once daily fo
Sponsors
Natural Remedies Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male and female participants (Healthy individuals will be defined as who do not require any continuous or urgent medical or surgical treatment for any systemic disease. Also with respect to skin, healthy skin will be defined as those without any skin blemishes of infective or non infective pathology like acne, hyper pigmentation or hypopigmentation etc.) 2. Willing to provide informed consent and comply with all requirements of the study protocol including follow up visits
Exclusion criteria
Exclusion criteria: 1.Participants with non intact skin surface for instrumental assessment (wounds, moles etc.) 2. Pregnant or nursing woman or planning a pregnancy during the study. 3. Participants with a skin tattoo, scar(s), mole(s), excessive hairs or any condition of the skin surface, which might interfere with the evaluation. 4. Participants who have been exposed to excessive sunlight or UV-rays within the previous month and are anticipated to be exposed during the study period. 5. Participants diagnosed with or having a history of hypertension, hyper or hypothyroidism 6. Participants diagnosed with anemia or are known cases of diabetes. 7. Participants suffering from any severe or progressive systemic or local disease or any other pathology that may interfere with the evaluation of the study results. 8. Participants with known history of or suffering from autoimmune disease and/or immune deficiency. 9. Participants suffering from inflammatory and/or infectious cutaneous disorders in or near the studied zones (herpes, acne, mycosis, papilloma) 10. Participants having received laser treatment or derma abrasion, surgery, deep chemical peeling or other ablative procedure on the cheeks or the neckline area within the past 1 month prior to the study 11. Participants having received resorbable filling product (injection) in the cheeks or the neckline area within the past 18 months prior to the study 12. Participants undergoing topical treatment on the test area or a systemic treatment including anti-histamines for the past 2 weeks prior to study; immunosuppressive and or corticoids for the last 4 weeks prior to study; retinoid for the 6 months prior to the study. 13. Known hypersensitivity to any of the ingredients of test products 14. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his or her participation in the stud
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in water content hydration of the skin surface assessed using Corneometer 2. Change in Trans epidermal water loss (TEWL) assessed using Tewameter Timepoint: Screening visit (up to 3 days), Baseline visit (Day 0), Visit 1 (week 4) and Visit 2 (Week 8) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in skin elasticity assessed using Cutometer 2. Change in skin softness and smoothness on graded scale 3. Change in Investigators Global Assessment on Likert 5 points scale 4. Assessment of adverse events adverse drug reactions including vitals Timepoint: Screening visit (up to 3 days), Baseline visit (Day 0), Visit 1 (week 4) and Visit 2 (Week 8) | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd
Outcome results
None listed