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

Skin Laxity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05986799
• Other study ID #: 23-RD-05-AY-001
• Status: Recruiting
• Phase: N/A
• Start date: August 13, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: August 2023
• Source: Amway (China) R&D Center
• Contact: Charlie Zhang, MD
• Phone: +8613901981272
• Email: charlie.zhang[@]sprimmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 30, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cutis Laxa
• Skin Laxity

Intervention

Dietary Supplement:
• Amway Herbal Drink
1 sachet per time, 3 times daily, for 3 months period.
• Placebo Drink
1 sachet per time, 3 times daily, for 3 months period.

Locations

Country	Name	City	State
China	Ai You Mei Medical Beauty Clinic	Jinhua	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Amway (China) R&D Center

Country where clinical trial is conducted

China, 

References & Publications (11)

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. — View 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. — View 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. — View 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. — View Citation

Cao C, Xiao Z, Wu Y, Ge C. Diet and Skin Aging-From the Perspective of Food Nutrition. Nutrients. 2020 Mar 24;12(3):870. doi: 10.3390/nu12030870. — View 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. — View Citation

Fam VW, Charoenwoodhipong P, Sivamani RK, Holt RR, Keen CL, Hackman RM. Plant-Based Foods for Skin Health: A Narrative Review. J Acad Nutr Diet. 2022 Mar;122(3):614-629. doi: 10.1016/j.jand.2021.10.024. Epub 2021 Oct 30. — View Citation

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. — View 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. — View 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. — View Citation

Zhou H, Zhou L, Li B, Yue R. Anti-cyclooxygenase, anti-glycation, and anti-skin aging effect of Dendrobium officinale flowers' aqueous extract and its phytochemical validation in aging. Front Immunol. 2023 Mar 17;14:1095848. doi: 10.3389/fimmu.2023.1095848. eCollection 2023. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Skin Elasticity	The changes of skin elasticity from baseline to day 90 by CK Cutometer MPA580	baseline day 0, day 90
Secondary	Change of Facial Lines/Wrinkles	The changes of facial lines/wrinkles by Miravex Antera 3D imaging system	baseline day 0, day 45, day 90