<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT02998944</url>
  </required_header>
  <id_info>
    <org_study_id>cctmcd</org_study_id>
    <nct_id>NCT02998944</nct_id>
  </id_info>
  <brief_title>The Study of CCTM and Common Diseases</brief_title>
  <official_title>the Association Study of Constitution of Traditional Chinese Medicine and Common Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Tongji Hospital, Tongji University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Huashan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shanghai Tongji Hospital, Tongji University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aimed to explore the associations between constitutions of traditional Chinese&#xD;
      medicine (TCM) and common disease (CD). A large-scale, community-based, cross-sectional study&#xD;
      was performed to investigate the associations. A total of 3748 participants were available&#xD;
      for analysis in this study. The assessment of constitution of TCM was based on&#xD;
      recommendations of Association Chinese Medicine in China. In this study, the diagnosis of CD&#xD;
      was based on self-reported medical history. The associations were analyzed using univariate&#xD;
      and multivariable logistic regression (MLR).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aimed to explore the associations between constitutions of traditional Chinese&#xD;
      medicine (TCM) and common disease (CD). A large-scale, community-based, cross-sectional study&#xD;
      was performed to investigate the associations. A total of 3748 participants were available&#xD;
      for analysis in this study. The assessment of constitution of TCM was based on&#xD;
      recommendations of Association Chinese Medicine in China. In this study, the diagnosis of CD&#xD;
      was based on self-reported medical history. The associations were analyzed using univariate&#xD;
      and multivariable logistic regression (MLR).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>hypertension</measure>
    <time_frame>through study completion, an average of 2 year</time_frame>
    <description>questionaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>diabetes mellitus</measure>
    <time_frame>through study completion, an average of 2 year</time_frame>
    <description>questionaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>coronary artery disease</measure>
    <time_frame>through study completion, an average of 2 year</time_frame>
    <description>questionaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>COPD</measure>
    <time_frame>through study completion, an average of 2 year</time_frame>
    <description>questionaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Obesty</measure>
    <time_frame>through study completion, an average of 2 year</time_frame>
    <description>calculation from height and weight</description>
  </primary_outcome>
  <enrollment type="Actual">3748</enrollment>
  <condition>Hypertension</condition>
  <condition>Diabetes Mellitus</condition>
  <condition>Chronic Obstructive Pulmonary Disease Moderate</condition>
  <condition>Coronary Artery Disease</condition>
  <condition>Obesity</condition>
  <eligibility>
    <study_pop>
      <textblock>
        A risk-factor study for constitution of TCM and chronic disease was conducted in a random&#xD;
        sample of the Chinese population. Participants aged 30-90 years were recruited from rural&#xD;
        and urban communities in Shanghai. More than 4,000 participants were invited to a screening&#xD;
        visit between 2011 and 2013. Written consent was obtained from all patients before the&#xD;
        study, which was performed in accordance with the ethical standards in the Declaration of&#xD;
        Helsinki, and approved by the Medicine Ethical Committee of the Huashan Hospital. The&#xD;
        exclusion criteria were 1) severity renal and liver function abnormal and 2) pregnant&#xD;
        woman. A total of 3748 participants were available to data analysis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants aged 30-90 years were recruited from rural and urban communities in&#xD;
             Shanghai.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severity renal and liver function abnormal and pregnant woman&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Fang P, Dong J, Zeng F, Tang Z. Analysis of the association between glucose profiles and beta-cell function for diabetic cardiovascular autonomic neuropathy in China. J Diabetes Investig. 2017 May;8(3):354-362. doi: 10.1111/jdi.12584. Epub 2016 Nov 25.</citation>
    <PMID>27736036</PMID>
  </reference>
  <reference>
    <citation>Lv Y, Zhou L, Tang Z, Dong J. Association and interaction analysis of diabetes mellitus and SCN10A for cardiovascular autonomic neuropathy in a Chinese population. Postgrad Med J. 2017 Jun;93(1100):344-348. doi: 10.1136/postgradmedj-2016-134202. Epub 2016 Oct 11.</citation>
    <PMID>27729462</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 4, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>December 16, 2016</last_update_submitted>
  <last_update_submitted_qc>December 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Huashan Hospital</investigator_affiliation>
    <investigator_full_name>Zihui Tang</investigator_full_name>
    <investigator_title>Attending physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02998944
org study id: cctmcd
nct id: NCT02998944
lead sponsor: 
collaborator: 
has dmc: No
This study aimed to explore the associations between constitutions of traditional Chinese
      medicine (TCM) and common disease (CD). A large-scale, community-based, cross-sectional study
      was performed to investigate the associations. A total of 3748 participants were available
      for analysis in this study. The assessment of constitution of TCM was based on
      recommendations of Association Chinese Medicine in China. In this study, the diagnosis of CD
      was based on self-reported medical history. The associations were analyzed using univariate
      and multivariable logistic regression (MLR).
This study aimed to explore the associations between constitutions of traditional Chinese
      medicine (TCM) and common disease (CD). A large-scale, community-based, cross-sectional study
      was performed to investigate the associations. A total of 3748 participants were available
      for analysis in this study. The assessment of constitution of TCM was based on
      recommendations of Association Chinese Medicine in China. In this study, the diagnosis of CD
      was based on self-reported medical history. The associations were analyzed using univariate
      and multivariable logistic regression (MLR).
observational model: Case-Crossover
time perspective: Cross-Sectional
measure: hypertension
time frame: through study completion, an average of 2 year
description: questionaire
measure: diabetes mellitus
time frame: through study completion, an average of 2 year
description: questionaire
measure: coronary artery disease
time frame: through study completion, an average of 2 year
description: questionaire
measure: COPD
time frame: through study completion, an average of 2 year
description: questionaire
measure: Obesty
time frame: through study completion, an average of 2 year
description: calculation from height and weight
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
citation: Fang P, Dong J, Zeng F, Tang Z. Analysis of the association between glucose profiles and beta-cell function for diabetic cardiovascular autonomic neuropathy in China. J Diabetes Investig. 2017 May;8(3):354-362. doi: 10.1111/jdi.12584. Epub 2016 Nov 25.
PMID: 27736036
citation: Lv Y, Zhou L, Tang Z, Dong J. Association and interaction analysis of diabetes mellitus and SCN10A for cardiovascular autonomic neuropathy in a Chinese population. Postgrad Med J. 2017 Jun;93(1100):344-348. doi: 10.1136/postgradmedj-2016-134202. Epub 2016 Oct 11.
PMID: 27729462
responsible party type: Principal Investigator
investigator affiliation: Huashan Hospital
investigator full name: Zihui Tang
investigator title: Attending physician
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Coronary Artery Disease
sharing ipd: No