Study to Evaluate the Efficacy of Blue Fenugreek Kale Extract (BFKE) on Skin

April 5, 2021 updated by: Vedic Lifesciences Pvt. Ltd.

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Blue Fenugreek Kale Extract (BFKE) on Skin.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Thāne, Maharashtra, India, 400602
        • Skin cure and care clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy, adult female participants aged ≥ 30 and ≤ 55 years.
  • 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:

  • Unwilling to forgo any aesthetic or dermatological treatments or procedures during the study period.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Blue fenugreek kale extract
One capsule to be taken orally before breakfast and one capsule after lunch, with water.
Other: Blue fenugreek kale extract
One capsule to be taken orally before breakfast and one capsule after lunch, with water.
Placebo Comparator: Placebo
One capsule to be taken orally before breakfast and one capsule after lunch, with water.
Other: Placebo
One capsule to be taken orally before breakfast and one capsule after lunch, with water.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Trans Epidermal Water Loss (TEWL) using Tewameter®.
Time Frame: From Base line Day 0 to day 56
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
Time Frame: From Base line Day 0 to day 56
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
Time Frame: From Base line Day 0 to day 56
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
Time Frame: From Base line Day 0 to day 56
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
Time Frame: From Base line Day 0 to day 56
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
Time Frame: From Base line Day 0 to day 56
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
Time Frame: From Base line Day 0 to day 56
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
Time Frame: From Base line Day 0 to day 56
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
Time Frame: From Base line Day 0 to day 56
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.
Time Frame: From Base line Day 0 to day 56
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.
Time Frame: From Base line Day 0 to day 56
malondialdehyde concentration of the samples will be measured as an index of lipid peroxidation
From Base line Day 0 to day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vedic Lifesciences Pvt. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 25, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MGB/191101/BFKE/SKNM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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