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Participants will be supplemented BFKE for a period of 8-weeks to improve skin health. The objective of the study is to evaluate the 'Transepidermal Water Loss (TEWL)' that characterizes the skin barrier function of stratum corneum. Additional parameters include, evaluation of skin moisture content, wrinkling, elasticity, sagging, radiance and also on inflammatory biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blue fenugreek kale extract | Active Comparator | One capsule to be taken orally before breakfast and one capsule after lunch, with water. |
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| Placebo | Placebo Comparator | One capsule to be taken orally before breakfast and one capsule after lunch, with water. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blue fenugreek kale extract | Other | One capsule to be taken orally before breakfast and one capsule after lunch, with water. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trans Epidermal Water Loss (TEWL) using Tewameter®. | To evaluate the effect of 8-week consumption of BFKE on skin barrier function as evaluated by Trans Epidermal Water Loss (TEWL) using Tewameter®. | From Base line Day 0 to day 56 |
| Skin moisture | skin hydration as measured by skin moisture (forehead & forearm) using skin moisture analyzer. | From Base line Day 0 to day 56 |
| Modified Fitzpatrick Wrinkle Severity Scale | Changes in the wrinkle class from Class 3.0 indicated worst means Deep wrinkle. Deep and furrow wrinkle; more than 3-mm wrinkle depth to Class 0 indicates Good means No wrinkle. No visible wrinkle; continuous skin line. | From Base line Day 0 to day 56 |
| Ezure Sagging scale | Cheek with Highest sagging score means Very severe sagging indicates worst and Lowest sagging score means No sagging indicates better | From Base line Day 0 to day 56 |
| Pinch recoil test | A decrease in pinch recoil time is associated with improvement in skin elasticity/firmness. | From Base line Day 0 to day 56 |
| Skin parameters using a participant based self-assessment questionnaire | Highest Score represents Better and lowest Score represents Worst | From Base line Day 0 to day 56 |
| Investigator's global assessment using 5-point Likert scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin cure and care clinic | Thane | Maharashtra | 400602 | India |
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| Placebo | Other | One capsule to be taken orally before breakfast and one capsule after lunch, with water. |
|
The Study Investigator will assess on a scale of 0 (Very poor) to 4 (Excellent) as to how beneficial or vice-versa was the treatment experience over the study period.
| From Base line Day 0 to day 56 |
| Participant's global assessment using 5-point Likert scale | The Participant will self-assess on a scale of 0 (Very poor) to 4 (Excellent) as to how beneficial or vice-versa was the treatment experience over the study period. | From Base line Day 0 to day 56 |
| Inflammatory biomarkers | Change in the levels of Inflammatory biomarkers within specified range | From Base line Day 0 to day 56 |
| Allergic skin inflammation as assessed by Eosinophil to basophil ratio and Neutrophil to lymphocyte ratio. | Change in the levels of Eosinophil to basophil ratio and Neutrophil to lymphocyte ratio within specified range | From Base line Day 0 to day 56 |
| Oxidative Stress as assessed by Malondialdehyde concentration. | malondialdehyde concentration of the samples will be measured as an index of lipid peroxidation | From Base line Day 0 to day 56 |