<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/NCT01669759</url>
  </required_header>
  <id_info>
    <org_study_id>DMR101-IRB2-151</org_study_id>
    <nct_id>NCT01669759</nct_id>
  </id_info>
  <brief_title>The Study in the Correlation Between the Severity of Post-stroke Fatigue and the Severity of qi Deficiency and Blood Stasis</brief_title>
  <official_title>The Study in the Correlation Between the Severity of Post-stroke Fatigue and the Severity of qi Deficiency and Blood Stasis 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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the present study was to investigate the correlation between the severity of&#xD;
      fatigue, and the severity of qi deficiency and blood stasis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to the reports of department of Health, stroke has been the top three ranking in&#xD;
      leading ten major mortality causes. Although fatigue is a common symptom after stroke, but it&#xD;
      is easy to neglect due to fatigue is a non-specific symptom. Based on the literature review,&#xD;
      fatigue symptom is not only common on post-stroke patient and it also has highly correlation&#xD;
      with mortality, prognosis and efficacy of rehabilitation. In Traditional Chinese Medicine&#xD;
      recording, Wang Qing-ren suggests that the main etiology of stroke is results from qi&#xD;
      stagnation and blood stasis, thereafter, the study about qi deficiency and blood stasis&#xD;
      became to the main stream for stroke until now. Therefore, the purpose of the present study&#xD;
      was to investigate the correlation between the severity of fatigue, and the severity of qi&#xD;
      deficiency and blood stasis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2012</start_date>
  <completion_date type="Anticipated">June 2013</completion_date>
  <primary_completion_date type="Anticipated">June 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Frome Fatigue severity level scale to evaluate fatigue severity score.</measure>
    <time_frame>about 20 minutes</time_frame>
    <description>When patient visit first time,we complete all the evaluation scale. Total evaluation time is about 20 minutes. And all data will be analyzed one year later.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Poststroke Fatigue</condition>
  <arm_group>
    <arm_group_label>fatigue</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with post-stroke fatigue were enrolled from the departments of neurological,&#xD;
        neurosurgical, and rehabilitation in China Medical University Hospital (Taichung, Taiwan),&#xD;
        their Brief Fatigue Inventory-Taiwan form score ≥ 4, and stroke onset more than 3 months.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Gender: men or women&#xD;
&#xD;
          2. Age:40~80 years old&#xD;
&#xD;
          3. Stroke history at least 3 months&#xD;
&#xD;
          4. Hemorrhage or ischemic stoke&#xD;
&#xD;
          5. Conscious clear and can communicate&#xD;
&#xD;
          6. Brief Fatigue Inventory-Taiwan form score ≥ 4&#xD;
&#xD;
          7. Sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient with psychotic diagnosis and can't cooperate with researcher&#xD;
&#xD;
          2. Major disease: chronic obstructive pulmonary disease, heart failure, myocardial&#xD;
             infarction, chronic renal failure, liver cirrhosis&#xD;
&#xD;
          3. Pregnant women&#xD;
&#xD;
          4. Breastfeeding women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yuan-Chen Chiu, Master of Chinese Medicine</last_name>
    <phone>886-4-22053366</phone>
    <phone_ext>3600</phone_ext>
    <email>jamy_chiu@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ching-Liang Hsieh, professor</last_name>
      <phone>886-4-22053366</phone>
      <phone_ext>3600</phone_ext>
      <email>clhsieh@mail.cmuh.org.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>August 20, 2012</last_update_submitted>
  <last_update_submitted_qc>August 20, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 21, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</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/NCT01669759
org study id: DMR101-IRB2-151
nct id: NCT01669759
lead sponsor: 
has dmc: No
The purpose of the present study was to investigate the correlation between the severity of
      fatigue, and the severity of qi deficiency and blood stasis.
According to the reports of department of Health, stroke has been the top three ranking in
      leading ten major mortality causes. Although fatigue is a common symptom after stroke, but it
      is easy to neglect due to fatigue is a non-specific symptom. Based on the literature review,
      fatigue symptom is not only common on post-stroke patient and it also has highly correlation
      with mortality, prognosis and efficacy of rehabilitation. In Traditional Chinese Medicine
      recording, Wang Qing-ren suggests that the main etiology of stroke is results from qi
      stagnation and blood stasis, thereafter, the study about qi deficiency and blood stasis
      became to the main stream for stroke until now. Therefore, the purpose of the present study
      was to investigate the correlation between the severity of fatigue, and the severity of qi
      deficiency and blood stasis.
time perspective: Cross-Sectional
measure: Frome Fatigue severity level scale to evaluate fatigue severity score.
time frame: about 20 minutes
description: When patient visit first time,we complete all the evaluation scale. Total evaluation time is about 20 minutes. And all data will be analyzed one year later.
arm group label: fatigue
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yuan-Chen Chiu, Master of Chinese Medicine
phone: 886-4-22053366
phone ext: 3600
email: jamy_chiu@hotmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Fatigue