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

Study Overview
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Brief Summary
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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.

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

Conditions
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Skin Laxity, Skin Lines

Intervention / Treatment
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* Dietary Supplement: Amway Herbal Drink
* Dietary Supplement: Placebo Drink


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Amway Herbal Drink<br>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<br>* 1 sachet per time, 3 times daily, for 3 months period.<br>|
| Placebo Comparator: Placebo Drink<br>Placebo Drink: 5g/sachet, containing the following active ingredients: Maltodextrin Sugar Honey | Dietary Supplement: Placebo Drink<br>* 1 sachet per time, 3 times daily, for 3 months period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Skin Elasticity | 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 | The changes of facial lines/wrinkles by Miravex Antera 3D imaging system | baseline day 0, day 45, day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anti-aging, Amway herbal drink