Skin LaxityNCT05986799
The Efficacy of Amway Herbal Drink to Improve Skin Anti-aging
A study testing Amway Herbal Drink in people with Skin Laxity and Skin Lines, run by Amway (China) R&D Center at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity, Skin Lines
- What is being tested?
- Amway Herbal Drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 13 Aug 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ai You Mei Medical Beauty Clinic
Jinhua, Zhejiang
Charlie BC Zhang, +8613901981272, charlie.zhang@sprimmedical.com
About this study
Official title: 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:
- whether skin elasticity will be improved measured by Cutometer
- whether skin wrinkles/roughness/pores will be improved measured by Antera 3D
Read more
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.
- Conditions
- Skin Laxity, Skin Lines
- Being tested
- Amway Herbal Drink, Placebo Drink
- Keywords
- Anti-aging, Amway herbal drink
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amway Herbal DrinkDietary supplement
1 sachet per time, 3 times daily, for 3 months period.
Placebo DrinkDietary supplement
1 sachet per time, 3 times daily, for 3 months period.
| Study group | Role | What they receive |
|---|---|---|
| Amway Herbal Drink | Active comparator | 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 Receives: Dietary Supplement: Amway Herbal Drink |
| Placebo Drink | Placebo comparator | Placebo Drink: 5g/sachet, containing the following active ingredients:
* Maltodextrin
* Sugar
* Honey Receives: Dietary Supplement: Placebo Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Skin Elasticity
The changes of skin elasticity from baseline to day 90 by CK Cutometer MPA580
Measured: baseline day 0, day 90
Secondary outcomes (1)
Change of Facial Lines/Wrinkles
The changes of facial lines/wrinkles by Miravex Antera 3D imaging system
Measured: baseline day 0, day 45, day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start13 Aug 2023 (estimated)
- Primary completion15 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Skin LaxityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amway (China) R&D Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yun Wang, MD, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986799
- Sponsor's protocol ID
- 23-RD-05-AY-001
- Status last verified
- Aug 2023
- First submitted
- 3 Aug 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32213934Blanpain 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.
PubMed 16824012Zhang 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.
PubMed 29692196Blume-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.
PubMed 26994263Michalak 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.
PubMed 35054770Fam 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.
PubMed 34728412Chaikul 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.
PubMed 34522633Binic 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.
PubMed 23431351Lee 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.
PubMed 35979399Benatrehina 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.
PubMed 29736381Zhou 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.
PubMed 37006297
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial of Efficacy of Amway Herbal Drink to Improve Skin Anti-aging
- ClinicalTrials.gov ID
- NCT05986799
- Acronym / sponsor ID
- 23-RD-05-AY-001
- Conditions
- Skin Laxity, Skin Lines
- Keywords
- Anti-aging, Amway herbal drink
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Amway (China) R&D CenterIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2023 (estimated)
- Primary completion
- 15 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amway Herbal Drink | Active comparator | Dietary Supplement: Amway Herbal DrinkAmway 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 | Placebo comparator | Dietary Supplement: Placebo DrinkPlacebo Drink: 5g/sachet, containing the following active ingredients: * Maltodextrin * Sugar * Honey |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (12 listed)
- 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.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amway Herbal Drink1 sachet per time, 3 times daily, for 3 months period. | Dietary supplement | Amway Herbal Drink |
| Placebo Drink1 sachet per time, 3 times daily, for 3 months period. | Dietary supplement | Placebo Drink |
Primary outcome
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
1 secondary outcome
Change of Facial Lines/Wrinkles
Time frame: baseline day 0, day 45, day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Background: PubMed 32213934Cao 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.
- Background: PubMed 16824012Blanpain 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.
- Background: PubMed 29692196Zhang 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.
- Background: PubMed 26994263Blume-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.
- Background: PubMed 35054770Michalak 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.
- Background: PubMed 34728412Fam 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.
- Background: PubMed 34522633Chaikul 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.
- Background: PubMed 23431351Binic 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.
- Background: PubMed 35979399Lee 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.
- Background: PubMed 29736381Benatrehina 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.
- Background: PubMed 37006297Zhou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun Wang, MD principal investigator
Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amway Herbal Drink in people with Skin Laxity and Skin Lines, run by Amway (China) R&D Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charlie Zhang, MD (+8613901981272, charlie.zhang@sprimmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Skin Elasticity (time frame: baseline day 0, day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05986799, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.