xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05986799</url>
    </required_header>
    <id_info>
      <org_study_id>23-RD-05-AY-001</org_study_id>
      <nct_id>NCT05986799</nct_id>
    </id_info>
    <brief_title>The Efficacy of Amway Herbal Drink to Improve Skin Anti-aging</brief_title>
    <official_title>A Randomized, Controlled Trial of Efficacy of Amway Herbal Drink to Improve Skin Anti-aging</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Amway (China) R&amp;D Center</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Amway (China) R&amp;D Center</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This goal of this two arms, randomized, double-blind controlled trial is to study whether&#xD;
        Amway herbal drink could improve skin anti-aging in the middle-aged people of 30-60 years&#xD;
        old. The main questions it aims to answer are:&#xD;
  &#xD;
          1. whether skin elasticity will be improved measured by Cutometer&#xD;
  &#xD;
          2. whether skin wrinkles/roughness/pores will be improved measured by Antera 3D&#xD;
  &#xD;
        30 eligible Participants will be enrolled in one center and randomly assigned to two study&#xD;
        groups (Amway herbal drink group and placebo drink group). Up to four study visits will be&#xD;
        made by the subject over a 3-month period intervention and all clinical data will be captured&#xD;
        and recorded into CTMS (Clinical Trial Management System) for data analysis and reporting.&#xD;
  &#xD;
        Researchers will compare Amway herbal drink group and placebo drink group to see if&#xD;
        consumption of Amway herbal drink could significantly improve skin anti-aging at the end of&#xD;
        the study.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 13, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 15, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change of Skin Elasticity</measure>
      <time_frame>baseline day 0, day 90</time_frame>
      <description>The changes of skin elasticity from baseline to day 90 by CK Cutometer MPA580</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change of Facial Lines/Wrinkles</measure>
      <time_frame>baseline day 0, day 45, day 90</time_frame>
      <description>The changes of facial lines/wrinkles by Miravex Antera 3D imaging system</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Skin Laxity</condition>
    <condition>Skin Lines</condition>
    <arm_group>
      <arm_group_label>Amway Herbal Drink</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Amway Herbal Drink: 5g/sachet, containing the following active ingredients:&#xD;
  Extract of Phyllanthus emblica&#xD;
  Sophora flower extract&#xD;
  Wild cherry extract&#xD;
  Flower extract of Dendrobium candidum&#xD;
  Pomegranate extract&#xD;
  Resistant dextrin&#xD;
  γ-cyclodextrin</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo Drink</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo Drink: 5g/sachet, containing the following active ingredients:&#xD;
  Maltodextrin&#xD;
  Sugar&#xD;
  Honey</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Amway Herbal Drink</intervention_name>
      <description>1 sachet per time, 3 times daily, for 3 months period.</description>
      <arm_group_label>Amway Herbal Drink</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Placebo Drink</intervention_name>
      <description>1 sachet per time, 3 times daily, for 3 months period.</description>
      <arm_group_label>Placebo Drink</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male and female subjects, aged 30 to 60 years, with a gender ratio of 3:7;&#xD;
  &#xD;
            -  Subjects are healthy;&#xD;
  &#xD;
            -  Visual assessment, smoothness is greater than or equal to 3 points (according to the&#xD;
               Test Method of Efficacy Measurement of Nourishing Cosmetic Products issued by Chinese&#xD;
               Association of Fragrance Flavor and Cosmetic Industries, the smaller the index, the&#xD;
               better. Please refer to appendix II);&#xD;
  &#xD;
            -  Visual assessment, the gloss index is greater than or equal to 4 points (according to&#xD;
               the Unilever Radiance Scale, the smaller the index is the better. Please refer to&#xD;
               appendix III);&#xD;
  &#xD;
            -  Subjects could not use facial whitening and moisturizing products during the trial;&#xD;
  &#xD;
            -  Agree not to take other oral products with similar efficacy (such as collagen, sodium&#xD;
               hyaluronate, etc.) during the trial. During the trial, participants agreed not to take&#xD;
               any drugs or supplements. Do not do any medical beauty projects during the trial, do&#xD;
               not participate in other interventional clinical research;&#xD;
  &#xD;
            -  Have a full understanding of the purpose, benefits, and possible risks and side&#xD;
               effects of the study;&#xD;
  &#xD;
            -  Willing to comply with all research requirements and procedures;&#xD;
  &#xD;
            -  Understand the test procedure, read, and sign an appropriate Informed Consent Form&#xD;
               indicating their willingness to participate.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Use of any medications or supplements that may alter skin properties during the first&#xD;
               3 months of enrollment;&#xD;
  &#xD;
            -  Skin disease patients;&#xD;
  &#xD;
            -  Ggastrointestinal symptoms being treated;&#xD;
  &#xD;
            -  Lactose intolerance, allergy to fish and its products;&#xD;
  &#xD;
            -  Present with other organic diseases that affect intestinal function, such as history&#xD;
               of gastrointestinal resection, colon or rectal cancer, inflammatory bowel disease,&#xD;
               diabetes, hyperthyroidism or hypothyroidism, congenital megacolon, scleroderma,&#xD;
               anorexia nervosa, etc.;&#xD;
  &#xD;
            -  Controlling diet, exercising more, or taking medications to control weight or affect&#xD;
               appetite in the last 3 months;&#xD;
  &#xD;
            -  Subjects have any of the following medical history or clinical findings that may&#xD;
               affect the evaluation of the trial effect: significant gastrointestinal disorders,&#xD;
               liver, kidney, endocrine, hematological, respiratory and cardiovascular diseases;&#xD;
  &#xD;
            -  Abuse of alcohol or other illicit drugs, supplements currently or in the past, or OTC&#xD;
               prescription drugs that may cause intestinal dysfunction or interfere with the&#xD;
               evaluation of trial effects;&#xD;
  &#xD;
            -  Frequent use of drugs that may affect gastrointestinal function or the immune system,&#xD;
               as judged by the researcher;&#xD;
  &#xD;
            -  Use of laxatives or other digestive substances in the 2 weeks prior to trial&#xD;
               commencement;&#xD;
  &#xD;
            -  Women who are pregnant or breastfeeding, or who plan to become pregnant during the&#xD;
               trial;&#xD;
  &#xD;
            -  PI considers that volunteers cannot fully cooperate with the trial arrangement.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yun Wang, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shanghai Jiao Tong University School of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Charlie Zhang, MD</last_name>
      <phone>+8613901981272</phone>
      <email>charlie.zhang@sprimmedical.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ai You Mei Medical Beauty Clinic</name>
        <address>
          <city>Jinhua</city>
          <state>Zhejiang</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Charlie BC Zhang</last_name>
        <phone>+8613901981272</phone>
        <email>charlie.zhang@sprimmedical.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <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.</citation>
      <PMID>32213934</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>16824012</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>29692196</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>26994263</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>35054770</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>34728412</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>34522633</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>23431351</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>35979399</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>29736381</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>37006297</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Anti-aging</keyword>
    <keyword>Amway herbal drink</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cutis Laxa</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05986799
  org study id: 23-RD-05-AY-001
  nct id: NCT05986799
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Double (Participant, Investigator)
  measure: Change of Skin Elasticity
  time frame: baseline day 0, day 90
  description: The changes of skin elasticity from baseline to day 90 by CK Cutometer MPA580
  measure: Change of Facial Lines/Wrinkles
  time frame: baseline day 0, day 45, day 90
  description: The changes of facial lines/wrinkles by Miravex Antera 3D imaging system
  arm group label: Amway Herbal Drink
  arm group type: Active Comparator
  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 group label: Placebo Drink
  arm group type: Placebo Comparator
  description: Placebo Drink: 5g/sachet, containing the following active ingredients:
  Maltodextrin
  Sugar
  Honey
  intervention type: Dietary Supplement
  intervention name: Amway Herbal Drink
  description: 1 sachet per time, 3 times daily, for 3 months period.
  arm group label: Amway Herbal Drink
  intervention type: Dietary Supplement
  intervention name: Placebo Drink
  description: 1 sachet per time, 3 times daily, for 3 months period.
  arm group label: Placebo Drink
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yun Wang, MD
  role: Principal Investigator
  affiliation: Shanghai Jiao Tong University School of Medicine
  last name: Charlie Zhang, MD
  phone: +8613901981272
  email: charlie.zhang@sprimmedical.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  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.
  PMID: 32213934
  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.
  PMID: 16824012
  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.
  PMID: 29692196
  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.
  PMID: 26994263
  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.
  PMID: 35054770
  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.
  PMID: 34728412
  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.
  PMID: 34522633
  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.
  PMID: 23431351
  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.
  PMID: 35979399
  citation: 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.
  PMID: 29736381
  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.
  PMID: 37006297
  responsible party type: Sponsor
  mesh term: Cutis Laxa
  sharing ipd: No