<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/NCT02993367</url>
  </required_header>
  <id_info>
    <org_study_id>ZYF55688</org_study_id>
    <nct_id>NCT02993367</nct_id>
  </id_info>
  <brief_title>The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND</brief_title>
  <acronym>EBSCPVCIND</acronym>
  <official_title>The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND:A Randomized, Double-blind,and Neuroimaging Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Second Hospital of Hebei Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Second Hospital of Hebei Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Vascular cognitive impairment no dementia (VCIND) is very common among the aged and tends to&#xD;
      progress to dementia, but there have been no proper large-scale intervention trials dedicated&#xD;
      to it. VCIND caused by subcortical ischemic small vessel disease (hereinafter, subcortical&#xD;
      VCIND) represents a relatively homogeneous disease process and is a suitable target for&#xD;
      therapeutic trials investigating VCIND. Preclinical trials showed that Butylphthalide Soft&#xD;
      Capsules is effective for cognitive impairment of vascular origin. In this randomized,&#xD;
      double-blind, placebo-controlled trial, the investigators apply fMRI study the effects of&#xD;
      Butylphthalide Soft Capsules in patients with VCIND.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">July 2019</completion_date>
  <primary_completion_date type="Anticipated">January 2019</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change of Cognitive function</measure>
    <time_frame>Time points 0, 1, 3 and 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>change of brain function</measure>
    <time_frame>Time point at 0, 1, 3, 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Vascular Cognitive Impairment no Dementia</condition>
  <arm_group>
    <arm_group_label>the Butylphthalide Soft Capsules group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>600mg Butylphthalide Soft Capsules/day,po tid,period of 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>the placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>60mg Butylphthalide Soft Capsules/day,po tid,period of 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Butylphthalide Soft Capsules</intervention_name>
    <description>DL-3-n-butylphthalide (NBP) (Fig. 1) is a synthetic chiral compound containing L- and D-isomers of butylphthalide.Butylphthalide Soft Capsules is the oral preparation.</description>
    <arm_group_label>the Butylphthalide Soft Capsules group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Butylphthalide Soft Capsules</intervention_name>
    <arm_group_label>the placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Literate Han Chinese aged from 40 to 65 years&#xD;
&#xD;
          -  MMSE ≥24&#xD;
&#xD;
          -  Normal or slightly impaired activities of daily living&#xD;
&#xD;
          -  The MRI entry criteria are as follows:&#xD;
&#xD;
               -  Subcortical small infarcts (3-20 mm in diameter),or one or more strategically&#xD;
                  located subcortical small infarcts in the caudate nucleus globus pallidus, or&#xD;
                  thalamus&#xD;
&#xD;
               -  Absence of cortical and watershed infarcts, hemorrhages, hydrocephalus, and WMLs&#xD;
                  with specific causes (e.g., multiple sclerosis); and&#xD;
&#xD;
               -  No hippocampal or entorhinal cortex atrophy (scored 0 according to medial&#xD;
                  temporal lobe atrophy scale of Scheltens)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with Diabetes mellitus&#xD;
&#xD;
          -  Disorders other than subcortical VCIND that may affect cognition; the score of&#xD;
             Hamilton depression scale more than 17 or schizophrenia&#xD;
&#xD;
          -  Clinically significant gastrointestinal, renal, hepatic, respiratory, infectious,&#xD;
             endocrine, or cardiovascular system disease; cancer; alcoholism; drug addiction; use&#xD;
             of medications that may affect cognitive functioning&#xD;
&#xD;
          -  Known hypersensitivity to celery&#xD;
&#xD;
          -  Inability to undergo a brain MRI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yifei Zhu, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Second Hospital of Hebei Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yifei Zhu, M.D.</last_name>
    <phone>+8613303046666</phone>
    <email>13831155688@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Panpan Liang, M.D.</last_name>
    <phone>+8617717711528</phone>
    <email>2354672781@qq.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Second Affiliated Hospital of Hebei medical university</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>zhu yifei, master</last_name>
      <phone>+8613303046666</phone>
      <email>13831155688@163.com</email>
    </contact>
    <contact_backup>
      <last_name>liang panpan, master</last_name>
      <phone>+8617717711528</phone>
      <email>674691785@qq.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Jia J, Wei C, Liang J, Zhou A, Zuo X, Song H, Wu L, Chen X, Chen S, Zhang J, Wu J, Wang K, Chu L, Peng D, Lv P, Guo H, Niu X, Chen Y, Dong W, Han X, Fang B, Peng M, Li D, Jia Q, Huang L. The effects of DL-3-n-butylphthalide in patients with vascular cognitive impairment without dementia caused by subcortical ischemic small vessel disease: A multicentre, randomized, double-blind, placebo-controlled trial. Alzheimers Dement. 2016 Feb;12(2):89-99. doi: 10.1016/j.jalz.2015.04.010. Epub 2015 Jun 15.</citation>
    <PMID>26086183</PMID>
  </results_reference>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>March 15, 2017</last_update_submitted>
  <last_update_submitted_qc>March 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Second Hospital of Hebei Medical University</investigator_affiliation>
    <investigator_full_name>Yifei Zhu</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Butylphthalide Soft Capsules</keyword>
  <keyword>VCIND</keyword>
  <keyword>fMRI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>3-n-butylphthalide</mesh_term>
  </intervention_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/NCT02993367
org study id: ZYF55688
nct id: NCT02993367
lead sponsor: 
has dmc: Yes
Vascular cognitive impairment no dementia (VCIND) is very common among the aged and tends to
      progress to dementia, but there have been no proper large-scale intervention trials dedicated
      to it. VCIND caused by subcortical ischemic small vessel disease (hereinafter, subcortical
      VCIND) represents a relatively homogeneous disease process and is a suitable target for
      therapeutic trials investigating VCIND. Preclinical trials showed that Butylphthalide Soft
      Capsules is effective for cognitive impairment of vascular origin. In this randomized,
      double-blind, placebo-controlled trial, the investigators apply fMRI study the effects of
      Butylphthalide Soft Capsules in patients with VCIND.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: change of Cognitive function
time frame: Time points 0, 1, 3 and 6 months
measure: change of brain function
time frame: Time point at 0, 1, 3, 6 months
arm group label: the Butylphthalide Soft Capsules group
arm group type: Experimental
description: 600mg Butylphthalide Soft Capsules/day,po tid,period of 6 months
arm group label: the placebo group
arm group type: Placebo Comparator
description: 60mg Butylphthalide Soft Capsules/day,po tid,period of 6 months
intervention type: Drug
intervention name: Butylphthalide Soft Capsules
description: DL-3-n-butylphthalide (NBP) (Fig. 1) is a synthetic chiral compound containing L- and D-isomers of butylphthalide.Butylphthalide Soft Capsules is the oral preparation.
arm group label: the Butylphthalide Soft Capsules group
intervention type: Drug
intervention name: Placebo Butylphthalide Soft Capsules
arm group label: the placebo group
criteria: 
gender: All
minimum age: 40 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yifei Zhu, M.D.
role: Principal Investigator
affiliation: The Second Hospital of Hebei Medical University
last name: Yifei Zhu, M.D.
phone: +8613303046666
email: 13831155688@163.com
last name: Panpan Liang, M.D.
phone: +8617717711528
email: 2354672781@qq.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
citation: Jia J, Wei C, Liang J, Zhou A, Zuo X, Song H, Wu L, Chen X, Chen S, Zhang J, Wu J, Wang K, Chu L, Peng D, Lv P, Guo H, Niu X, Chen Y, Dong W, Han X, Fang B, Peng M, Li D, Jia Q, Huang L. The effects of DL-3-n-butylphthalide in patients with vascular cognitive impairment without dementia caused by subcortical ischemic small vessel disease: A multicentre, randomized, double-blind, placebo-controlled trial. Alzheimers Dement. 2016 Feb;12(2):89-99. doi: 10.1016/j.jalz.2015.04.010. Epub 2015 Jun 15.
PMID: 26086183
responsible party type: Principal Investigator
investigator affiliation: The Second Hospital of Hebei Medical University
investigator full name: Yifei Zhu
investigator title: Clinical Professor
mesh term: Dementia
mesh term: Cognitive Dysfunction
mesh term: 3-n-butylphthalide