The Evaluation of Chenopodium Formosanum and Fagopyrum Esculentum Extract on Anti-aging Effect

November 27, 2020 updated by: TCI Co., Ltd.
To assess Chenopodium Formosanum and Fagopyrum Esculentum Extract on skin anti-aging

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.
50

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

  • Taiwan
      • Taichung, Taiwan, 404
        • China Medical University

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

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adults aged between 20-65 years old
  • Subjects must read and sign the informed consent form after the study has been fully explained.
  • Subjects are willing to cooperate and comply with all of the regulation during the trial.
  • Subject should inform to investigator immediately if adverse effect is happened.
  • Subjects are willing to avoid UV overexposure during the trial (include indoor tanning treatment).

Exclusion Criteria:

  • Subjects who have known cosmetic, drug or food allergies.
  • Subjects who have severe desquamation, tattoo, sunburn, peeling skin or other skin condition might impact measurement.
  • Subjects with any physical condition judged by the researcher not to be eligible for this study.
  • Subjects with uncontrollable physical condition such as high blood pressure, thyroid disease, diabetes, etc.
  • Female who is pregnant or nursing or planning to become pregnant during the course of the study.
  • Those who are currently participating in other clinical trials or who have just concluded a clinical trial two weeks ago.
  • Women who have started contraceptive or change current hormone contraceptive methods within 3 months.

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: Double

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.
Placebo Comparator: Placebo drink
Dietary supplement: Placebo drink
consume 2 bottle (30 mL) per day for 56 days
Experimental: Chenopodium Formosanum and Fagopyrum Esculentum Extract drink
Dietary supplement: Chenopodium Formosanum and Fagopyrum Esculentum Extract drink
consume 2 bottle (30 mL) per day for 56 days

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
The change of skin moisture
Time Frame: Change from Baseline skin moisture at 8 weeks
Corneometer® CM825 is utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120
Change from Baseline skin moisture at 8 weeks
The change of skin elasticity
Time Frame: Change from Baseline skin elasticity at 8 weeks
Cutometer® dual MPA 580 is utilized to measure skin elasticity (parameter R2). Units: μm penetration depth into the probe opening, expressed as curves
Change from Baseline skin elasticity at 8 weeks
The change of skin wrinkles
Time Frame: Change from Baseline skin wrinkles at 8 weeks
3D Full-Face Skin Analyzer IRV is utilized to measure wrinkles. Units: arbitrary units
Change from Baseline skin wrinkles at 8 weeks
The change of skin collagen density
Time Frame: Change from Baseline skin collagen density at 8 weeks
DermaLab® combo - 20 MHz High Freq. Ultrasound probe is utilized to scan and analyze skin collagen density. Units: Intensity score
Change from Baseline skin collagen density at 8 weeks
The change of skin tone
Time Frame: Change from Baseline skin tone at 8 weeks
3D Full-Face Skin Analyzer IRV was utilized to measure skin tone. Units: arbitrary units
Change from Baseline skin tone at 8 weeks
The change of skin brightness
Time Frame: Change from Baseline skin brightness at 8 weeks
3D Full-Face Skin Analyzer IRV is utilized to measure skin brightness. Units: arbitrary units
Change from Baseline skin brightness at 8 weeks
The change of skin melanin index
Time Frame: Change from Baseline skin melanin index at 8 weeks
Mexameter® MX 18 is utilized to measure skin melanin index. Units: arbitrary Mexameter® units (0-999)
Change from Baseline skin melanin index at 8 weeks
The change of skin L*a*b* value
Time Frame: Change from Baseline skin L*a*b* value at 8 weeks
Color Spectrophotometer SCM-104/108 is utilized to measure skin L*a*b* value. Units: arbitrary units
Change from Baseline skin L*a*b* value at 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The change of transepidermal water loss (TEWL)
Time Frame: Change from Baseline TEWL at 8 weeks
Tewameter® TM 300 is utilized to measure transepidermal water loss. Units: g/hm²
Change from Baseline TEWL at 8 weeks
The change of skin texture
Time Frame: Change from Baseline skin texture at 8 weeks
3D Full-Face Skin Analyzer IRV is utilized to measure skin texture. Units: arbitrary units
Change from Baseline skin texture at 8 weeks
The change of skin pores
Time Frame: Change from Baseline skin pores at 8 weeks
3D Full-Face Skin Analyzer IRV is utilized to measure skin pores. Units: arbitrary units
Change from Baseline skin pores at 8 weeks
The change of skin spots
Time Frame: Change from Baseline skin spots at 8 weeks
3D Full-Face Skin Analyzer IRV is utilized to measure skin spots. Units: arbitrary units
Change from Baseline skin spots at 8 weeks
The change of skin erythema level
Time Frame: Change from Baseline skin erythema level at 8 weeks
Mexameter® MX 18 is utilized to measure skin erythema level. Units: arbitrary Mexameter® units (0-999)
Change from Baseline skin erythema level at 8 weeks
Self-assessment questionnaire
Time Frame: 8 weeks
Questionnaire is utilized to assess skin condition of the subjects. Units: score
8 weeks

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.
TCI Co., 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.
February 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.
April 30, 2020

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.
August 15, 2020

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).
January 19, 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.
January 22, 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.
January 23, 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.
November 30, 2020

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.
November 27, 2020

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.
January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • CMUH108-REC1-147

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings