<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/NCT02999048</url>
  </required_header>
  <id_info>
    <org_study_id>2012CC47</org_study_id>
    <nct_id>NCT02999048</nct_id>
  </id_info>
  <brief_title>Clinical Study on the Treatment of Hypertensive Intracerebral Hemorrhage With Panax Notoginseng Saponin</brief_title>
  <acronym>CSTHIHPNS</acronym>
  <official_title>Clinical Study on the Treatment of Hypertensive Cerebral Hemorrhage With Panax Notoginseng Saponins</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First People's Hospital of Jingzhou</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First People's Hospital of Jingzhou</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether panax notoginseng saponins are effective in&#xD;
      the treatment of Hypertensive Intracerebral Hemorrhage Patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with HICH were randomly assigned to receive either PNS integrated with conventional&#xD;
      therapy. Patients were treated with conventional therapy for 3 days, then plus PNS for 14&#xD;
      days. Patients in the control group received conventional therapy for 17days. Hematoma volume&#xD;
      measured by CT scanning, National Institutes of Health Stroke Scale (NIHSS) scores, Barthel&#xD;
      index (BI), all the three were used to evaluate the therapeutic effect for both groups after&#xD;
      two weeks of intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>Phase 4</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hematoma volume</measure>
    <time_frame>within the 14 days after two weeks of intervention</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>National Institutes of Health Stroke Scale (NIHSS) scores</measure>
    <time_frame>within the 14 days after two weeks of intervention</time_frame>
    <description>were measured for stroke severity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Barthel index</measure>
    <time_frame>within the 14 days after two weeks of intervention</time_frame>
    <description>were measured for quality of life</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>adverse events</measure>
    <time_frame>14 days</time_frame>
    <description>such as rash, allergic shock</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Hematoma Absorption and Neurological Function Recovery</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in the control group received conventional therapy for 17 days.conventional therapy consists of: (1) dehydration therapy by 20%mannitol (Tianjin Bane Medical Drugs Ltd., Co., China.) with the dosage from 125 to 250 ml every 8 h for 7 days depending on their clinically presumed intracranial pressure, (2) therapy to deal with complications including glucose-lowering treatment for hyperglycemia, antihypertensive treatment for hypertension, anti-inflammatory treatment for infection, acid inhibitor for peptic ulcer, and (3) supportive therapy, such as physical cooling, nutritional support, fluid, and electrolyte balance, which was provided as needed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>intervention group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients in the intervention group received the same conventional therapy as in the control group for 3 days, brain CT was re-scanned at the 4th day, and was then given conventional therapy plus XUESAITONG Injection,which was mainly composed of Panax notoginseng saponins for 14 days from the 4th day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Panax Notoginseng Saponins</intervention_name>
    <description>Panax Notoginseng Saponins integrated with conventional therapy</description>
    <arm_group_label>intervention group</arm_group_label>
    <other_name>XUESAITONG Injection</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  with a history of hypertension treated with medication and blood pressure management (&#xD;
             a systolic blood-pressure target of 140 to 179 mmHg and a diastolic blood-pressure&#xD;
             target of 70 to 100 mmHg) during the period of hospitalization,&#xD;
&#xD;
          -  the site of hematoma located in one of the cerebral hemispheres,&#xD;
&#xD;
          -  hematoma volume 10-30ml,&#xD;
&#xD;
          -  no blood in the ventricles,&#xD;
&#xD;
          -  within 24 hours of onset of first-time acute intracerebral hemorrhage,&#xD;
&#xD;
          -  no loss of consciousness (drowsiness acceptable).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cerebellar or brainstem hemorrhage,&#xD;
&#xD;
          -  intracerebral hemorrhage caused by bleeding diathesis, aneurysms, vascular&#xD;
             malformations, improperly using anticoagulant drugs, or suspicious amyloid angiopathy,&#xD;
&#xD;
          -  subarachnoid hemorrhage; multifocal hemorrhage,&#xD;
&#xD;
          -  mixed stroke or hemorrhagic infarct,&#xD;
&#xD;
          -  coexisting systematic diseases such as heart or kidney failure, tumors,&#xD;
             gastrointestinal hemorrhage and so on,&#xD;
&#xD;
          -  pregnant or lactating women,&#xD;
&#xD;
          -  a history of XUESAITONG injection anaphylaxis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <results_reference>
    <citation>Cheung RT. Update on medical and surgical management of intracerebral hemorrhage. Rev Recent Clin Trials. 2007 Sep;2(3):174-81. doi: 10.2174/157488707781662751.</citation>
    <PMID>18474003</PMID>
  </results_reference>
  <results_reference>
    <citation>Nilsson OG, Lindgren A, Brandt L, Saveland H. Prediction of death in patients with primary intracerebral hemorrhage: a prospective study of a defined population. J Neurosurg. 2002 Sep;97(3):531-6. doi: 10.3171/jns.2002.97.3.0531.</citation>
    <PMID>12296635</PMID>
  </results_reference>
  <results_reference>
    <citation>Zhao X, Wang Y, Wang C, Li S, Wang Y, Yang Z. Quantitative evaluation for secondary injury to perihematoma of hypertensive cerebral hemorrhage by functional MR and correlation analysis with ischemic factors. Neurol Res. 2006 Jan;28(1):66-70. doi: 10.1179/016164106X91898.</citation>
    <PMID>16464365</PMID>
  </results_reference>
  <results_reference>
    <citation>Kang DW, Han MK, Kim HJ, Yun SC, Jeon SB, Bae HJ, Kwon SU, Kim JS. New ischemic lesions coexisting with acute intracerebral hemorrhage. Neurology. 2012 Aug 28;79(9):848-55. doi: 10.1212/WNL.0b013e3182648a79. Epub 2012 Jul 25.</citation>
    <PMID>22843271</PMID>
  </results_reference>
  <results_reference>
    <citation>Li JY, Yuan LX, Zhang GM, Zhou L, Gao Y, Li QB, Chen C. Activating blood circulation to remove stasis treatment of hypertensive intracerebral hemorrhage: A multi-center prospective randomized open-label blinded-endpoint trial. Chin J Integr Med. 2016 May;22(5):328-34. doi: 10.1007/s11655-016-2467-7. Epub 2016 Apr 30.</citation>
    <PMID>27338955</PMID>
  </results_reference>
  <results_reference>
    <citation>Chen X, Zhou M, Li Q, Yang J, Zhang Y, Zhang D, Kong S, Zhou D, He L. Sanchi for acute ischaemic stroke. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD006305. doi: 10.1002/14651858.CD006305.pub2.</citation>
    <PMID>18843711</PMID>
  </results_reference>
  <results_reference>
    <citation>Zhang X, Wu J, Zhang B. Xuesaitong injection as one adjuvant treatment of acute cerebral infarction: a systematic review and meta-analysis. BMC Complement Altern Med. 2015 Feb 27;15:36. doi: 10.1186/s12906-015-0560-4.</citation>
    <PMID>25888429</PMID>
  </results_reference>
  <results_reference>
    <citation>Kim CH, Kim JS. Development of cerebral infarction shortly after intracerebral hemorrhage. Eur Neurol. 2007;57(3):145-9. doi: 10.1159/000098465. Epub 2007 Jan 10.</citation>
    <PMID>17213720</PMID>
  </results_reference>
  <results_reference>
    <citation>Nyquist P. Management of acute intracranial and intraventricular hemorrhage. Crit Care Med. 2010 Mar;38(3):946-53. doi: 10.1097/CCM.0b013e3181d16a04.</citation>
    <PMID>20068459</PMID>
  </results_reference>
  <results_reference>
    <citation>Wasserman JK, Zhu X, Schlichter LC. Evolution of the inflammatory response in the brain following intracerebral hemorrhage and effects of delayed minocycline treatment. Brain Res. 2007 Nov 14;1180:140-54. doi: 10.1016/j.brainres.2007.08.058. Epub 2007 Sep 5.</citation>
    <PMID>17919462</PMID>
  </results_reference>
  <results_reference>
    <citation>Sun K, Wang CS, Guo J, Liu YY, Wang F, Liu LY, He JG, Fan JY, Han JY. Effect of Panax notoginseng saponins on lipopolysaccharide-induced adhesion of leukocytes in rat mesenteric venules. Clin Hemorheol Microcirc. 2006;34(1-2):103-8.</citation>
    <PMID>16543624</PMID>
  </results_reference>
  <results_reference>
    <citation>Wang YX, Yan A, Ma ZH, Wang Z, Zhang B, Ping JL, Zhu JS, Zhou Y, Dai L. Nuclear factor-kappaB and apoptosis in patients with intracerebral hemorrhage. J Clin Neurosci. 2011 Oct;18(10):1392-5. doi: 10.1016/j.jocn.2010.11.039. Epub 2011 Jul 22.</citation>
    <PMID>21782444</PMID>
  </results_reference>
  <results_reference>
    <citation>Li H, Deng CQ, Chen BY, Zhang SP, Liang Y, Luo XG. Total saponins of Panax notoginseng modulate the expression of caspases and attenuate apoptosis in rats following focal cerebral ischemia-reperfusion. J Ethnopharmacol. 2009 Jan 30;121(3):412-8. doi: 10.1016/j.jep.2008.10.042. Epub 2008 Nov 18.</citation>
    <PMID>19059471</PMID>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 13, 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>The First People's Hospital of Jingzhou</investigator_affiliation>
    <investigator_full_name>Zhijian Luo</investigator_full_name>
    <investigator_title>deputy chief physician, neurology physician</investigator_title>
  </responsible_party>
  <keyword>panax notoginseng saponins</keyword>
  <keyword>hypertensive intracerebral hemorrhage</keyword>
  <keyword>hematoma</keyword>
  <keyword>neurological function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Hemorrhage, Hypertensive</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Hematoma</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/NCT02999048
org study id: 2012CC47
nct id: NCT02999048
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether panax notoginseng saponins are effective in
      the treatment of Hypertensive Intracerebral Hemorrhage Patients.
Patients with HICH were randomly assigned to receive either PNS integrated with conventional
      therapy. Patients were treated with conventional therapy for 3 days, then plus PNS for 14
      days. Patients in the control group received conventional therapy for 17days. Hematoma volume
      measured by CT scanning, National Institutes of Health Stroke Scale (NIHSS) scores, Barthel
      index (BI), all the three were used to evaluate the therapeutic effect for both groups after
      two weeks of intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Hematoma volume
time frame: within the 14 days after two weeks of intervention
measure: National Institutes of Health Stroke Scale (NIHSS) scores
time frame: within the 14 days after two weeks of intervention
description: were measured for stroke severity
measure: Barthel index
time frame: within the 14 days after two weeks of intervention
description: were measured for quality of life
measure: adverse events
time frame: 14 days
description: such as rash, allergic shock
arm group label: control group
arm group type: No Intervention
description: Patients in the control group received conventional therapy for 17 days.conventional therapy consists of: (1) dehydration therapy by 20%mannitol (Tianjin Bane Medical Drugs Ltd., Co., China.) with the dosage from 125 to 250 ml every 8 h for 7 days depending on their clinically presumed intracranial pressure, (2) therapy to deal with complications including glucose-lowering treatment for hyperglycemia, antihypertensive treatment for hypertension, anti-inflammatory treatment for infection, acid inhibitor for peptic ulcer, and (3) supportive therapy, such as physical cooling, nutritional support, fluid, and electrolyte balance, which was provided as needed.
arm group label: intervention group
arm group type: Other
description: Patients in the intervention group received the same conventional therapy as in the control group for 3 days, brain CT was re-scanned at the 4th day, and was then given conventional therapy plus XUESAITONG Injection,which was mainly composed of Panax notoginseng saponins for 14 days from the 4th day.
intervention type: Drug
intervention name: Panax Notoginseng Saponins
description: Panax Notoginseng Saponins integrated with conventional therapy
arm group label: intervention group
other name: XUESAITONG Injection
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
citation: Cheung RT. Update on medical and surgical management of intracerebral hemorrhage. Rev Recent Clin Trials. 2007 Sep;2(3):174-81. doi: 10.2174/157488707781662751.
PMID: 18474003
citation: Nilsson OG, Lindgren A, Brandt L, Saveland H. Prediction of death in patients with primary intracerebral hemorrhage: a prospective study of a defined population. J Neurosurg. 2002 Sep;97(3):531-6. doi: 10.3171/jns.2002.97.3.0531.
PMID: 12296635
citation: Zhao X, Wang Y, Wang C, Li S, Wang Y, Yang Z. Quantitative evaluation for secondary injury to perihematoma of hypertensive cerebral hemorrhage by functional MR and correlation analysis with ischemic factors. Neurol Res. 2006 Jan;28(1):66-70. doi: 10.1179/016164106X91898.
PMID: 16464365
citation: Kang DW, Han MK, Kim HJ, Yun SC, Jeon SB, Bae HJ, Kwon SU, Kim JS. New ischemic lesions coexisting with acute intracerebral hemorrhage. Neurology. 2012 Aug 28;79(9):848-55. doi: 10.1212/WNL.0b013e3182648a79. Epub 2012 Jul 25.
PMID: 22843271
citation: Li JY, Yuan LX, Zhang GM, Zhou L, Gao Y, Li QB, Chen C. Activating blood circulation to remove stasis treatment of hypertensive intracerebral hemorrhage: A multi-center prospective randomized open-label blinded-endpoint trial. Chin J Integr Med. 2016 May;22(5):328-34. doi: 10.1007/s11655-016-2467-7. Epub 2016 Apr 30.
PMID: 27338955
citation: Chen X, Zhou M, Li Q, Yang J, Zhang Y, Zhang D, Kong S, Zhou D, He L. Sanchi for acute ischaemic stroke. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD006305. doi: 10.1002/14651858.CD006305.pub2.
PMID: 18843711
citation: Zhang X, Wu J, Zhang B. Xuesaitong injection as one adjuvant treatment of acute cerebral infarction: a systematic review and meta-analysis. BMC Complement Altern Med. 2015 Feb 27;15:36. doi: 10.1186/s12906-015-0560-4.
PMID: 25888429
citation: Kim CH, Kim JS. Development of cerebral infarction shortly after intracerebral hemorrhage. Eur Neurol. 2007;57(3):145-9. doi: 10.1159/000098465. Epub 2007 Jan 10.
PMID: 17213720
citation: Nyquist P. Management of acute intracranial and intraventricular hemorrhage. Crit Care Med. 2010 Mar;38(3):946-53. doi: 10.1097/CCM.0b013e3181d16a04.
PMID: 20068459
citation: Wasserman JK, Zhu X, Schlichter LC. Evolution of the inflammatory response in the brain following intracerebral hemorrhage and effects of delayed minocycline treatment. Brain Res. 2007 Nov 14;1180:140-54. doi: 10.1016/j.brainres.2007.08.058. Epub 2007 Sep 5.
PMID: 17919462
citation: Sun K, Wang CS, Guo J, Liu YY, Wang F, Liu LY, He JG, Fan JY, Han JY. Effect of Panax notoginseng saponins on lipopolysaccharide-induced adhesion of leukocytes in rat mesenteric venules. Clin Hemorheol Microcirc. 2006;34(1-2):103-8.
PMID: 16543624
citation: Wang YX, Yan A, Ma ZH, Wang Z, Zhang B, Ping JL, Zhu JS, Zhou Y, Dai L. Nuclear factor-kappaB and apoptosis in patients with intracerebral hemorrhage. J Clin Neurosci. 2011 Oct;18(10):1392-5. doi: 10.1016/j.jocn.2010.11.039. Epub 2011 Jul 22.
PMID: 21782444
citation: Li H, Deng CQ, Chen BY, Zhang SP, Liang Y, Luo XG. Total saponins of Panax notoginseng modulate the expression of caspases and attenuate apoptosis in rats following focal cerebral ischemia-reperfusion. J Ethnopharmacol. 2009 Jan 30;121(3):412-8. doi: 10.1016/j.jep.2008.10.042. Epub 2008 Nov 18.
PMID: 19059471
responsible party type: Principal Investigator
investigator affiliation: The First People's Hospital of Jingzhou
investigator full name: Zhijian Luo
investigator title: deputy chief physician, neurology physician
mesh term: Intracranial Hemorrhage, Hypertensive
mesh term: Hemorrhage
mesh term: Hematoma