<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/NCT04472754</url>
  </required_header>
  <id_info>
    <org_study_id>8388</org_study_id>
    <nct_id>NCT04472754</nct_id>
  </id_info>
  <brief_title>The Biological Basis of Phlegm Dampness Syndrome in Patients With Ischemic Stroke：A Saliva and Urine Proteomics Study</brief_title>
  <official_title>The Biological Basis of Phlegm Dampness Syndrome in Patients With Ischemic Stroke：A Saliva and Urine Proteomics Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Guangzhou Cadre Health Management Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Guangzhou University of Traditional Chinese Medicine</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>
      This study aimed to explorie the biological basis of phlegm-dampness syndrome in patients&#xD;
      with ischemic stroke using proteomics research techniques of urine and saliva.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stroke is the disease with the highest mortality and disability in China, and the annual&#xD;
      incidence of ischemic stroke is the highest. Atherosclerosis is the main cause of ischemic&#xD;
      stroke. According to the theory of traditional Chinese medicine, the disease is closely&#xD;
      related to the physical constitution of the individual. The main body constitution of the&#xD;
      population in Lingnan area is phlegm dampness syndrome;Previous large cross-sectional studies&#xD;
      have found that 65.3% of patients with ischemic stroke in Lingnan area have phlegm dampness&#xD;
      syndrome. However, there is currently no biological evidence related to phlegm-dampness&#xD;
      syndrome and ischemic stroke.In recent years, proteomics research technology has developed&#xD;
      vigorously. The research samples have developed from blood obtained from minimally invasive&#xD;
      to urine and saliva obtained non-invasively. Studies have found that urine proteins&#xD;
      associated with AS include type I, type III collagen, 8-isoprostaglandin F2α, and saliva&#xD;
      proteins include IL-1β, IL-6, TNF-α, and PGE2.Therefore, this research is dedicated to&#xD;
      exploring the biological basis of phlegm-dampness syndrome in patients with ischemic stroke&#xD;
      using proteomics research techniques of urine and saliva.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 20, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Differentially expressed proteins of urine and saliva</measure>
    <time_frame>1 day</time_frame>
    <description>Proteomic expression of urine and saliva in each group will be tested use Protein liquid chromatography/mass spectrometry detection.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>NIHSS scoes</measure>
    <time_frame>1 day</time_frame>
    <description>NIHSS scoring scale for neurological impairment assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>modified Rankin Scale (mRS) score</measure>
    <time_frame>1 day</time_frame>
    <description>mRS score for the degree of dependence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BI index</measure>
    <time_frame>1 day</time_frame>
    <description>BI index for living ability assessment</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Protein; Disease</condition>
  <arm_group>
    <arm_group_label>A(healthy control group)</arm_group_label>
    <description>patients who did not have ischemic stroke and whose TCM constitution was dialectically peaceful;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B</arm_group_label>
    <description>Patients with no ischemic stroke and whose TCM constitution was dialectical with damp phlegm constitution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C</arm_group_label>
    <description>patients with ischemic stroke diagnosed with phlegm dampness syndrome</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D</arm_group_label>
    <description>patients with ischemic stroke diagnosed as non-phlegm dampness syndrome</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      All the saliva and urine samples will be stored in the biological resource centre of the our&#xD;
      research centre after written informed consent obtained from all subjects who voluntarily&#xD;
      participated in this clinical study.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Study population are people who diagnosed as ischemic stroke at Guangdong Provincial&#xD;
        Hospital of Chinese Medicine The healthy volunteers are definted as people who have no&#xD;
        history of cerebrovascular diseases (including cerebral hemorrhage, cerebral infarction,&#xD;
        transient ischemic attack, etc.)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Clinical diagnosis of ischemic stroke&#xD;
&#xD;
          2. Aged 35-80-year-old.&#xD;
&#xD;
          3. Agree to participate in clinical research and sign informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Clinical diagnosis of cerebral hemorrhage;&#xD;
&#xD;
          2. With severe infection, severe renal dysfunction, and tumor;&#xD;
&#xD;
          3. Clinical diagnosis of acute oral inflammation, oral ulcers, or urinary infections;&#xD;
&#xD;
          4. Clinical diagnosis of systemic lupus erythematosus and rheumatoid arthritis;&#xD;
&#xD;
          5. Pregnant women or lactating mothers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>July 11, 2020</last_update_submitted>
  <last_update_submitted_qc>July 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ischemic stroke</keyword>
  <keyword>phlegm dampness syndrome</keyword>
  <keyword>traditional Chinese medicine</keyword>
  <keyword>proteomic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ischemic Stroke</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/NCT04472754
org study id: 8388
nct id: NCT04472754
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aimed to explorie the biological basis of phlegm-dampness syndrome in patients
      with ischemic stroke using proteomics research techniques of urine and saliva.
Stroke is the disease with the highest mortality and disability in China, and the annual
      incidence of ischemic stroke is the highest. Atherosclerosis is the main cause of ischemic
      stroke. According to the theory of traditional Chinese medicine, the disease is closely
      related to the physical constitution of the individual. The main body constitution of the
      population in Lingnan area is phlegm dampness syndrome;Previous large cross-sectional studies
      have found that 65.3% of patients with ischemic stroke in Lingnan area have phlegm dampness
      syndrome. However, there is currently no biological evidence related to phlegm-dampness
      syndrome and ischemic stroke.In recent years, proteomics research technology has developed
      vigorously. The research samples have developed from blood obtained from minimally invasive
      to urine and saliva obtained non-invasively. Studies have found that urine proteins
      associated with AS include type I, type III collagen, 8-isoprostaglandin F2α, and saliva
      proteins include IL-1β, IL-6, TNF-α, and PGE2.Therefore, this research is dedicated to
      exploring the biological basis of phlegm-dampness syndrome in patients with ischemic stroke
      using proteomics research techniques of urine and saliva.
observational model: Cohort
time perspective: Prospective
measure: Differentially expressed proteins of urine and saliva
time frame: 1 day
description: Proteomic expression of urine and saliva in each group will be tested use Protein liquid chromatography/mass spectrometry detection.
measure: NIHSS scoes
time frame: 1 day
description: NIHSS scoring scale for neurological impairment assessment
measure: modified Rankin Scale (mRS) score
time frame: 1 day
description: mRS score for the degree of dependence
measure: BI index
time frame: 1 day
description: BI index for living ability assessment
arm group label: A(healthy control group)
description: patients who did not have ischemic stroke and whose TCM constitution was dialectically peaceful;
arm group label: B
description: Patients with no ischemic stroke and whose TCM constitution was dialectical with damp phlegm constitution
arm group label: C
description: patients with ischemic stroke diagnosed with phlegm dampness syndrome
arm group label: D
description: patients with ischemic stroke diagnosed as non-phlegm dampness syndrome
All the saliva and urine samples will be stored in the biological resource centre of the our
      research centre after written informed consent obtained from all subjects who voluntarily
      participated in this clinical study.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Ischemic Stroke