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/NCT06007573</url>
    </required_header>
    <id_info>
      <org_study_id>2021-zj-21</org_study_id>
      <nct_id>NCT06007573</nct_id>
    </id_info>
    <brief_title>Acupuncture Combined With Nimodipine for Prevention of Post-stroke Dementia</brief_title>
    <official_title>Acupuncture Combined With Nimodipine for Prevention of Post-stroke Dementia:a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yuzhen Pan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Department of acupuncture and massage, Nanling Hospital of traditional Chinese Medicine, Nanling County, Wuhu City, Anhui Province</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine</source>
    <oversight_info>
      <has_dmc>No</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>
        To observe the clinical efficacy of TCM acupuncture combined with western medicine nimodipine&#xD;
        for prevention of post-stroke dementia by comparing with clinical conventional treatment&#xD;
        methods.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 1, 2021</start_date>
    <completion_date type="Actual">August 15, 2023</completion_date>
    <primary_completion_date type="Actual">August 1, 2023</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>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Response Rate</measure>
      <time_frame>24 weeks</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hasegawa Dementia Scale</measure>
      <time_frame>24 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Montreal Cognitive Assessment</measure>
      <time_frame>24 weeks</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>Post-stroke Dementia</condition>
    <arm_group>
      <arm_group_label>treatment group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>On the basis of the control group treatment, the treatment group also adopted the acupuncture treatment</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>The control group received oral nimodipine tablets</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>The control group received oral nimodipine tablets</intervention_name>
      <description>The control group received oral nimodipine tablets</description>
      <arm_group_label>control group</arm_group_label>
      <arm_group_label>treatment group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Definite ischemic stroke or hemorrhagic stroke confirmed by head CT / MRI examination&#xD;
  &#xD;
            2. Memory or cognitive and executive dysfunction. Cognitive dysfunction will be&#xD;
               determined after the mini mental state evaluation (MMSE) score&#xD;
  &#xD;
            3. Age limited to 40-85 years, irrespective of gender&#xD;
  &#xD;
            4. Stable condition, clear consciousness, no aphasia, oral medication available&#xD;
  &#xD;
            5. No major comorbidity, no major depression&#xD;
  &#xD;
            6. Consent and signed patient informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Had serious medical conditions, such as heart, liver, kidney, or endocrine disease&#xD;
  &#xD;
            2. Aphasia or hearing impairment&#xD;
  &#xD;
            3. Participants in other clinical trials&#xD;
  &#xD;
            4. Patients currently on medication to improve cognitive function&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>The Second Affiliated Hospital of Anhui University of Chinese Medicine</name>
        <address>
          <city>Hefei</city>
          <state>Anhui</state>
          <zip>230031</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine</investigator_affiliation>
      <investigator_full_name>Yuzhen Pan</investigator_full_name>
      <investigator_title>DOCTOR</investigator_title>
    </responsible_party>
    <keyword>randomized controlled trial</keyword>
    <keyword>post-stroke dementia</keyword>
    <keyword>Acupuncture</keyword>
    <keyword>nimodipine</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</mesh_term>
      <mesh_term>Dementia</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Nimodipine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>At present, we have not made a decision on whether to share all IPD. This is because we need to consider a range of factors, including ethical principles, legal requirements, privacy protection, and data sharing agreements. We are carefully evaluating these factors and will make a clear decision as soon as possible.</ipd_description>
    </patient_data>
    <!-- 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/NCT06007573
  org study id: 2021-zj-21
  nct id: NCT06007573
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To observe the clinical efficacy of TCM acupuncture combined with western medicine nimodipine
        for prevention of post-stroke dementia by comparing with clinical conventional treatment
        methods.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: Response Rate
  time frame: 24 weeks
  measure: Hasegawa Dementia Scale
  time frame: 24 weeks
  measure: Montreal Cognitive Assessment
  time frame: 24 weeks
  arm group label: treatment group
  arm group type: Experimental
  description: On the basis of the control group treatment, the treatment group also adopted the acupuncture treatment
  arm group label: control group
  arm group type: Other
  description: The control group received oral nimodipine tablets
  intervention type: Drug
  intervention name: The control group received oral nimodipine tablets
  description: The control group received oral nimodipine tablets
  arm group label: control group
  arm group label: treatment group
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 85 Years
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
  investigator full name: Yuzhen Pan
  investigator title: DOCTOR
  mesh term: Stroke
  mesh term: Dementia
  mesh term: Nimodipine
  sharing ipd: No
  ipd description: At present, we have not made a decision on whether to share all IPD. This is because we need to consider a range of factors, including ethical principles, legal requirements, privacy protection, and data sharing agreements. We are carefully evaluating these factors and will make a clear decision as soon as possible.