Study to Evaluate the Efficacy of Blue Fenugreek Kale Extract (BFKE) on Skin
NCT ID: NCT04544982
Last Updated: 2021-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2020-09-01
2021-03-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Blue fenugreek kale extract
One capsule to be taken orally before breakfast and one capsule after lunch, with water.
Blue fenugreek kale extract
One capsule to be taken orally before breakfast and one capsule after lunch, with water.
Placebo
One capsule to be taken orally before breakfast and one capsule after lunch, with water.
Placebo
One capsule to be taken orally before breakfast and one capsule after lunch, with water.
Interventions
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Blue fenugreek kale extract
One capsule to be taken orally before breakfast and one capsule after lunch, with water.
Placebo
One capsule to be taken orally before breakfast and one capsule after lunch, with water.
Eligibility Criteria
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Inclusion Criteria
* Participants with signs of poor skin barrier as determined by Trans-epidermal water loss ≥ 15 g/m2/h on forehead.
* Participants with skin type II to IV as per Fitzpatrick skin type calculator.
* Participants with skin type II and III as per Glogau's classification of photoageing skin.
* Participants must have Body Mass Index (BMI) ≥ 18.5 ≤ 29.9 kg/m2.
* Participants with moderate signs of Melasma as assessed by the investigators.
* Participants ready to abstain from any cosmetic or drug-based cream, ointment, lotion and other products apart from the ones allowed during study period.
* Participants ready to rinse their face only with water and to refrain from using soap, facewash, make-up etc. or any other cosmetic care related products 12 hrs. prior to any assessment visit.
Exclusion Criteria
* Participants with visible scarring on face.
* Participants having any form of skin disorder on the Nasolabial fold.
* Water consumption history of ≤ 500 ml and ≥ 3000 ml per day.
* Smoking or using any tobacco products.
* Participants presently undergoing or had undergone treatment for softening or reducing wrinkles in the last 3 months.
* Having a history of chronic skin allergies.
* History of heavy caffeine usage ≥ 4 cups in a day.
* Binge drinkers as defined by consumption of 4 or more alcohol containing beverages within 2 hours.
* Presence of unstable, acutely symptomatic, or life-limiting illness.
* Participants taking any vitamins and other related supplements.
* Menopausal and peri-menopausal females.
* Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
* Females who have had participated in a study of an investigational product 90 days prior to the screening.
30 Years
55 Years
FEMALE
Yes
Sponsors
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Vedic Lifesciences Pvt. Ltd.
INDUSTRY
Responsible Party
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Locations
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Skin cure and care clinic
Thāne, Maharashtra, India
Countries
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Other Identifiers
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MGB/191101/BFKE/SKNM
Identifier Type: -
Identifier Source: org_study_id
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