Clinical trial NCT05986799: 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
Overall status: RECRUITING
Phase: NA
Conditions: Skin Laxity
Skin Lines
Keywords: Anti-aging
Amway herbal drink
Lead sponsor: Amway (China) R&D Center
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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:

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.


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.

Primary outcomes:
measure: Change of Skin Elasticity
timeFrame: baseline day 0, day 90
Secondary outcomes:
measure: Change of Facial Lines/Wrinkles
timeFrame: baseline day 0, day 45, day 90
Other outcomes:
Locations:
city: Jinhua
country: China
facility: Ai You Mei Medical Beauty Clinic
state: Zhejiang
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Yun Wang, MD
role: PRINCIPAL_INVESTIGATOR
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