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

Primary Purpose

Skin Laxity, Skin Lines

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Amway Herbal Drink
Placebo Drink
Sponsored by
Amway (China) R&D Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Skin Laxity focused on measuring Anti-aging, Amway herbal drink

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ai You Mei Medical Beauty ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Amway Herbal Drink

Placebo Drink

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change of Skin Elasticity
The changes of skin elasticity from baseline to day 90 by CK Cutometer MPA580

Secondary Outcome Measures

Change of Facial Lines/Wrinkles
The changes of facial lines/wrinkles by Miravex Antera 3D imaging system

Full Information

First Posted
August 3, 2023
Last Updated
August 3, 2023
Sponsor
Amway (China) R&D Center
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1. Study Identification

Unique Protocol Identification Number
NCT05986799
Brief Title
The Efficacy of Amway Herbal Drink to Improve Skin Anti-aging
Official Title
A Randomized, Controlled Trial of Efficacy of Amway Herbal Drink to Improve Skin Anti-aging
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 13, 2023 (Anticipated)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amway (China) R&D Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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: whether skin elasticity will be improved measured by Cutometer 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Laxity, Skin Lines
Keywords
Anti-aging, Amway herbal drink

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Amway Herbal Drink
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo Drink
Arm Type
Placebo Comparator
Arm Description
Placebo Drink: 5g/sachet, containing the following active ingredients: Maltodextrin Sugar Honey
Intervention Type
Dietary Supplement
Intervention Name(s)
Amway Herbal Drink
Intervention Description
1 sachet per time, 3 times daily, for 3 months period.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Drink
Intervention Description
1 sachet per time, 3 times daily, for 3 months period.
Primary Outcome Measure Information:
Title
Change of Skin Elasticity
Description
The changes of skin elasticity from baseline to day 90 by CK Cutometer MPA580
Time Frame
baseline day 0, day 90
Secondary Outcome Measure Information:
Title
Change of Facial Lines/Wrinkles
Description
The changes of facial lines/wrinkles by Miravex Antera 3D imaging system
Time Frame
baseline day 0, day 45, day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlie Zhang, MD
Phone
+8613901981272
Email
charlie.zhang@sprimmedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun Wang, MD
Organizational Affiliation
Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ai You Mei Medical Beauty Clinic
City
Jinhua
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlie BC Zhang
Phone
+8613901981272
Email
charlie.zhang@sprimmedical.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32213934
Citation
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Results Reference
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16824012
Citation
Blanpain C, Fuchs E. Epidermal stem cells of the skin. Annu Rev Cell Dev Biol. 2006;22:339-73. doi: 10.1146/annurev.cellbio.22.010305.104357.
Results Reference
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PubMed Identifier
29692196
Citation
Zhang S, Duan E. Fighting against Skin Aging: The Way from Bench to Bedside. Cell Transplant. 2018 May;27(5):729-738. doi: 10.1177/0963689717725755. Epub 2018 Apr 25.
Results Reference
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PubMed Identifier
26994263
Citation
Blume-Peytavi U, Kottner J, Sterry W, Hodin MW, Griffiths TW, Watson RE, Hay RJ, Griffiths CE. Age-Associated Skin Conditions and Diseases: Current Perspectives and Future Options. Gerontologist. 2016 Apr;56 Suppl 2:S230-42. doi: 10.1093/geront/gnw003.
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PubMed Identifier
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Citation
Michalak M. Plant-Derived Antioxidants: Significance in Skin Health and the Ageing Process. Int J Mol Sci. 2022 Jan 6;23(2):585. doi: 10.3390/ijms23020585.
Results Reference
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PubMed Identifier
34728412
Citation
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PubMed Identifier
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Citation
Chaikul P, Kanlayavattanakul M, Somkumnerd J, Lourith N. Phyllanthus emblica L. (amla) branch: A safe and effective ingredient against skin aging. J Tradit Complement Med. 2021 Feb 9;11(5):390-399. doi: 10.1016/j.jtcme.2021.02.004. eCollection 2021 Sep.
Results Reference
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PubMed Identifier
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Citation
Binic I, Lazarevic V, Ljubenovic M, Mojsa J, Sokolovic D. Skin ageing: natural weapons and strategies. Evid Based Complement Alternat Med. 2013;2013:827248. doi: 10.1155/2013/827248. Epub 2013 Jan 29.
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PubMed Identifier
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Lee HR, Ryu HG, Lee Y, Park JA, Kim S, Lee CE, Jung S, Lee KH. Effect of Aronia Extract on Collagen Synthesis in Human Skin Cell and Dermal Equivalent. Oxid Med Cell Longev. 2022 Aug 8;2022:4392256. doi: 10.1155/2022/4392256. eCollection 2022.
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Benatrehina PA, Pan L, Naman CB, Li J, Kinghorn AD. Usage, biological activity, and safety of selected botanical dietary supplements consumed in the United States. J Tradit Complement Med. 2018 Mar 2;8(2):267-277. doi: 10.1016/j.jtcme.2018.01.006. eCollection 2018 Apr.
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Citation
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Results Reference
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The Efficacy of Amway Herbal Drink to Improve Skin Anti-aging

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