The Efficacy of Amway Herbal Drink to Improve Skin Anti-aging

August 3, 2023 updated by: Amway (China) R&D Center

A Randomized, Controlled Trial of Efficacy of Amway Herbal Drink to Improve Skin Anti-aging

This goal of this two arms, randomized, double-blind controlled trial is to study whether Amway herbal drink could improve skin anti-aging in the middle-aged people of 30-60 years old. The main questions it aims to answer are:

  1. whether skin elasticity will be improved measured by Cutometer
  2. whether skin wrinkles/roughness/pores will be improved measured by Antera 3D

30 eligible Participants will be enrolled in one center and randomly assigned to two study groups (Amway herbal drink group and placebo drink group). Up to four study visits will be made by the subject over a 3-month period intervention and all clinical data will be captured and recorded into CTMS (Clinical Trial Management System) for data analysis and reporting.

Researchers will compare Amway herbal drink group and placebo drink group to see if consumption of Amway herbal drink could significantly improve skin anti-aging at the end of the study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • 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 Contact

Study Locations

  • China
    • Zhejiang
      • Jinhua, Zhejiang, China

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male and female subjects, aged 30 to 60 years, with a gender ratio of 3:7;
  • Subjects are healthy;
  • Visual assessment, smoothness is greater than or equal to 3 points (according to the Test Method of Efficacy Measurement of Nourishing Cosmetic Products issued by Chinese Association of Fragrance Flavor and Cosmetic Industries, the smaller the index, the better. Please refer to appendix II);
  • Visual assessment, the gloss index is greater than or equal to 4 points (according to the Unilever Radiance Scale, the smaller the index is the better. Please refer to appendix III);
  • Subjects could not use facial whitening and moisturizing products during the trial;
  • Agree not to take other oral products with similar efficacy (such as collagen, sodium hyaluronate, etc.) during the trial. During the trial, participants agreed not to take any drugs or supplements. Do not do any medical beauty projects during the trial, do not participate in other interventional clinical research;
  • Have a full understanding of the purpose, benefits, and possible risks and side effects of the study;
  • Willing to comply with all research requirements and procedures;
  • Understand the test procedure, read, and sign an appropriate Informed Consent Form indicating their willingness to participate.

Exclusion Criteria:

  • Use of any medications or supplements that may alter skin properties during the first 3 months of enrollment;
  • Skin disease patients;
  • Ggastrointestinal symptoms being treated;
  • Lactose intolerance, allergy to fish and its products;
  • Present with other organic diseases that affect intestinal function, such as history of gastrointestinal resection, colon or rectal cancer, inflammatory bowel disease, diabetes, hyperthyroidism or hypothyroidism, congenital megacolon, scleroderma, anorexia nervosa, etc.;
  • Controlling diet, exercising more, or taking medications to control weight or affect appetite in the last 3 months;
  • Subjects have any of the following medical history or clinical findings that may affect the evaluation of the trial effect: significant gastrointestinal disorders, liver, kidney, endocrine, hematological, respiratory and cardiovascular diseases;
  • Abuse of alcohol or other illicit drugs, supplements currently or in the past, or OTC prescription drugs that may cause intestinal dysfunction or interfere with the evaluation of trial effects;
  • Frequent use of drugs that may affect gastrointestinal function or the immune system, as judged by the researcher;
  • Use of laxatives or other digestive substances in the 2 weeks prior to trial commencement;
  • Women who are pregnant or breastfeeding, or who plan to become pregnant during the trial;
  • PI considers that volunteers cannot fully cooperate with the trial arrangement.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Amway Herbal Drink

Amway Herbal Drink: 5g/sachet, containing the following active ingredients:

  • Extract of Phyllanthus emblica
  • Sophora flower extract
  • Wild cherry extract
  • Flower extract of Dendrobium candidum
  • Pomegranate extract
  • Resistant dextrin
  • γ-cyclodextrin
Dietary supplement: Amway Herbal Drink
1 sachet per time, 3 times daily, for 3 months period.
Placebo Comparator: Placebo Drink

Placebo Drink: 5g/sachet, containing the following active ingredients:

  • Maltodextrin
  • Sugar
  • Honey
Dietary supplement: Placebo Drink
1 sachet per time, 3 times daily, for 3 months period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Skin Elasticity
Time Frame: baseline day 0, day 90
The changes of skin elasticity from baseline to day 90 by CK Cutometer MPA580
baseline day 0, day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Facial Lines/Wrinkles
Time Frame: baseline day 0, day 45, day 90
The changes of facial lines/wrinkles by Miravex Antera 3D imaging system
baseline day 0, day 45, day 90

Collaborators and Investigators

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

Sponsor

Amway (China) R&D Center

Investigators

  • Principal Investigator: Yun Wang, MD, Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

August 13, 2023

Primary Completion (Estimated)

November 15, 2023

Study Completion (Estimated)

November 30, 2023

Study Registration Dates

First Submitted

August 3, 2023

First Submitted That Met QC Criteria

August 3, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-RD-05-AY-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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