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/NCT05988593</url>
    </required_header>
    <id_info>
      <org_study_id>CMUH111-REC3-127</org_study_id>
      <nct_id>NCT05988593</nct_id>
    </id_info>
    <brief_title>Testing the Cognitive Facilitation Effect by Dietary Supplementation of MelaGene+ Drink</brief_title>
    <official_title>Testing the Cognitive Facilitation Effect by Dietary Supplementation of MelaGene+ Drink</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>TCI Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>TCI Co., Ltd.</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To assess the efficacy of MelaGene+ on cognitive performance&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 1, 2022</start_date>
    <completion_date type="Actual">May 31, 2023</completion_date>
    <primary_completion_date type="Actual">November 30, 2022</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>Other</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The change of Match to sample test</measure>
      <time_frame>Change from Baseline match to sample test value at 8 weeks</time_frame>
      <description>The number of memorized cards was utilized to measure Match to sample test value.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The change of Trail making test</measure>
      <time_frame>Change from Baseline Trail making test value at 8 weeks</time_frame>
      <description>The time of finishing actions was utilized to measure Trail making test value.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The change of Processing speed test</measure>
      <time_frame>Change from Baseline Processing speed test value at 8 weeks</time_frame>
      <description>The number of pressing buttons was utilized to measure Processing speed test value.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The change of Mnemonic Similarity Task</measure>
      <time_frame>Change from Baseline Mnemonic Similarity Task value at 8 weeks</time_frame>
      <description>The proportion of correction about ability on memorizing old things was utilized to measure Mnemonic Similarity Task value.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The change of facial expression cuing task</measure>
      <time_frame>Change from Baseline facial expression cuing task value at 8 weeks</time_frame>
      <description>The correction of evaluation on facial emotion was utilized to measure facial expression cuing task value.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The change of State-trait anxiety inventory</measure>
      <time_frame>Change from Baseline State-trait anxiety inventory value at 8 weeks</time_frame>
      <description>The scores of anxiety state was utilized to measure State-trait anxiety inventory value.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The change of score of fatigue</measure>
      <time_frame>Change from Baseline PSS (The Perceived Stress Scale)-14 value at 8 weeks</time_frame>
      <description>The PSS (The Perceived Stress Scale)-14 questionnaire was utilized to measure fatigue condition.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The change of score of life quality</measure>
      <time_frame>Change from Baseline WHOQOL-BREF (The World Health Organization Quality of Life Brief Version) value at 8 weeks</time_frame>
      <description>The WHOQOL-BREF (The World Health Organization Quality of Life Brief Version) questionnaire was utilized to measure life quality.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">64</enrollment>
    <condition>Cognitive Change</condition>
    <arm_group>
      <arm_group_label>placebo drink</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>MelaGene+</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>placebo</intervention_name>
      <description>consume one bottle (30 mL) per day</description>
      <arm_group_label>placebo drink</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>MelaGene+</intervention_name>
      <description>consume one bottle (30 mL) per day</description>
      <arm_group_label>MelaGene+</arm_group_label>
      <other_name>Melaleuca-MelaGene+</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  20 to 65-year-old males or females&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participants are breastfeeding, pregnant or planning to become pregnant during the&#xD;
               test (self-report)&#xD;
  &#xD;
            -  Participants with heart, liver, kidney, endocrine and other major organic diseases&#xD;
               (self-reported)&#xD;
  &#xD;
            -  Participants take drugs for a long time (self-report)&#xD;
  &#xD;
            -  Participants with mental illness or have undergone brain surgery&#xD;
  &#xD;
            -  Participants still can not clearly see words with 12pt on computer after corrected&#xD;
               vision&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jing-Ling Li</last_name>
      <role>Principal Investigator</role>
      <affiliation>China Medical University, China</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>China Medical University</name>
        <address>
          <city>Taichung</city>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 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>
    <!-- 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/NCT05988593
  org study id: CMUH111-REC3-127
  nct id: NCT05988593
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To assess the efficacy of MelaGene+ on cognitive performance
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Double (Participant, Investigator)
  measure: The change of Match to sample test
  time frame: Change from Baseline match to sample test value at 8 weeks
  description: The number of memorized cards was utilized to measure Match to sample test value.
  measure: The change of Trail making test
  time frame: Change from Baseline Trail making test value at 8 weeks
  description: The time of finishing actions was utilized to measure Trail making test value.
  measure: The change of Processing speed test
  time frame: Change from Baseline Processing speed test value at 8 weeks
  description: The number of pressing buttons was utilized to measure Processing speed test value.
  measure: The change of Mnemonic Similarity Task
  time frame: Change from Baseline Mnemonic Similarity Task value at 8 weeks
  description: The proportion of correction about ability on memorizing old things was utilized to measure Mnemonic Similarity Task value.
  measure: The change of facial expression cuing task
  time frame: Change from Baseline facial expression cuing task value at 8 weeks
  description: The correction of evaluation on facial emotion was utilized to measure facial expression cuing task value.
  measure: The change of State-trait anxiety inventory
  time frame: Change from Baseline State-trait anxiety inventory value at 8 weeks
  description: The scores of anxiety state was utilized to measure State-trait anxiety inventory value.
  measure: The change of score of fatigue
  time frame: Change from Baseline PSS (The Perceived Stress Scale)-14 value at 8 weeks
  description: The PSS (The Perceived Stress Scale)-14 questionnaire was utilized to measure fatigue condition.
  measure: The change of score of life quality
  time frame: Change from Baseline WHOQOL-BREF (The World Health Organization Quality of Life Brief Version) value at 8 weeks
  description: The WHOQOL-BREF (The World Health Organization Quality of Life Brief Version) questionnaire was utilized to measure life quality.
  arm group label: placebo drink
  arm group type: Placebo Comparator
  arm group label: MelaGene+
  arm group type: Experimental
  intervention type: Dietary Supplement
  intervention name: placebo
  description: consume one bottle (30 mL) per day
  arm group label: placebo drink
  intervention type: Dietary Supplement
  intervention name: MelaGene+
  description: consume one bottle (30 mL) per day
  arm group label: MelaGene+
  other name: Melaleuca-MelaGene+
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jing-Ling Li
  role: Principal Investigator
  affiliation: China Medical University, China
  facility: 
  country: Taiwan
  responsible party type: Sponsor