<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/NCT04434924</url>
  </required_header>
  <id_info>
    <org_study_id>CMUH109-REC1-025</org_study_id>
    <nct_id>NCT04434924</nct_id>
  </id_info>
  <brief_title>The Construction of Precision Medicine in Chinese Medicine</brief_title>
  <official_title>The Construction of Precision Medicine in Chinese Medicine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Medical University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China Medical University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      &quot;Precise medicine&quot; is also called &quot;personal medicine&quot;. With the development of big data&#xD;
      database, genetic testing and artificial intelligence, the concept of precision medicine has&#xD;
      been applied to the diagnosis, treatment and prevention of different diseases. Traditional&#xD;
      Chinese medicine (TCM) has traditionally emphasis on personalized medicine, according to each&#xD;
      person's body constitution, through discriminatory treatment and personalized treatment&#xD;
      methods. Chinese medicine doctors collect patients' information to distinguish the type of&#xD;
      TCM pattern, and then according to the different types of diagnosis of traditional Chinese&#xD;
      medicine to decide of using herbs, acupuncture, massage and other treatment strategies.&#xD;
      However, lacking of objective data of traditional Chinese medicine, the current research on&#xD;
      precision medicine in Chinese medicine is still limited. The aim of this study is to&#xD;
      establish a big database of traditional Chinese precision medicine, and use the patients with&#xD;
      hypertension as the population to conduct research on precision medicine in Chinese&#xD;
      medicine.This study will combine the TCM body constitutional questionnaire, tongue diagnosis,&#xD;
      pulse diagnosis, Chinese medicine immunoassay and genetic testing. In addition, the&#xD;
      information providing by the medical electronic medical record system of China Medical&#xD;
      University Hospital will be connected, which include modern medical diagnosis, treatment,&#xD;
      blood and biochemical analysis and imaging. We will combine the big data analysis and&#xD;
      artificial intelligence interpretation technology to explore the correlation between&#xD;
      different TCM syndrome types and gene variations in patients with hypertension and establish&#xD;
      a database of TCM precision medicine. We will also conduct the education training and&#xD;
      symposium to train TCM precision medical talents and promote public understanding of TCM&#xD;
      precision medicine. This project will establish a database of traditional Chinese medicine&#xD;
      precision medicine to provide the correlation between different TCM pattern types of patients&#xD;
      with hypertension, the reaction to different herbal medicine, and gene mutation, and provide&#xD;
      reference for TCM clinicians.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 24, 2020</start_date>
  <completion_date type="Actual">May 31, 2022</completion_date>
  <primary_completion_date type="Actual">May 31, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The correlation between TCM body constitution and genetic variation</measure>
    <time_frame>2 years</time_frame>
    <description>The correlation between TCM body constitution and genetic variation of patients with primary hypertension will be investigated.</description>
  </primary_outcome>
  <enrollment type="Actual">600</enrollment>
  <condition>Hypertension</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients were diagnosed as having primary hypertension by cardiologists.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Primary hypertension&#xD;
&#xD;
          2. Older than 20 year-old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Past history of cancer&#xD;
&#xD;
          2. Hemodialysis&#xD;
&#xD;
          3. Hypertension caused by renal diseases or endocrine disorders&#xD;
&#xD;
          4. Pregnancy&#xD;
&#xD;
          5. Patients can not received investigation of body constitution, TCM tongue examination&#xD;
             and pulse examination&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>404</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>July 18, 2022</last_update_submitted>
  <last_update_submitted_qc>July 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Traditional Chinese precision medicine</keyword>
  <keyword>Chinese medicine immunoassay</keyword>
  <keyword>Body constitution</keyword>
  <keyword>genetic variation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04434924
org study id: CMUH109-REC1-025
nct id: NCT04434924
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
"Precise medicine" is also called "personal medicine". With the development of big data
      database, genetic testing and artificial intelligence, the concept of precision medicine has
      been applied to the diagnosis, treatment and prevention of different diseases. Traditional
      Chinese medicine (TCM) has traditionally emphasis on personalized medicine, according to each
      person's body constitution, through discriminatory treatment and personalized treatment
      methods. Chinese medicine doctors collect patients' information to distinguish the type of
      TCM pattern, and then according to the different types of diagnosis of traditional Chinese
      medicine to decide of using herbs, acupuncture, massage and other treatment strategies.
      However, lacking of objective data of traditional Chinese medicine, the current research on
      precision medicine in Chinese medicine is still limited. The aim of this study is to
      establish a big database of traditional Chinese precision medicine, and use the patients with
      hypertension as the population to conduct research on precision medicine in Chinese
      medicine.This study will combine the TCM body constitutional questionnaire, tongue diagnosis,
      pulse diagnosis, Chinese medicine immunoassay and genetic testing. In addition, the
      information providing by the medical electronic medical record system of China Medical
      University Hospital will be connected, which include modern medical diagnosis, treatment,
      blood and biochemical analysis and imaging. We will combine the big data analysis and
      artificial intelligence interpretation technology to explore the correlation between
      different TCM syndrome types and gene variations in patients with hypertension and establish
      a database of TCM precision medicine. We will also conduct the education training and
      symposium to train TCM precision medical talents and promote public understanding of TCM
      precision medicine. This project will establish a database of traditional Chinese medicine
      precision medicine to provide the correlation between different TCM pattern types of patients
      with hypertension, the reaction to different herbal medicine, and gene mutation, and provide
      reference for TCM clinicians.
observational model: Cohort
time perspective: Cross-Sectional
measure: The correlation between TCM body constitution and genetic variation
time frame: 2 years
description: The correlation between TCM body constitution and genetic variation of patients with primary hypertension will be investigated.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Hypertension