<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/NCT03271697</url>
  </required_header>
  <id_info>
    <org_study_id>CMUH106-REC1-074</org_study_id>
    <nct_id>NCT03271697</nct_id>
  </id_info>
  <brief_title>Astragalus Membranaceus on Aneurysmal Subarachnoid Hemorrhage</brief_title>
  <acronym>AMASH</acronym>
  <official_title>Efficacy Study of Astragalus Membranaceus on Aneurysmal Subarachnoid Hemorrhage</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research is trying to see if AM can enhance the clinical prognosis for spontaneous&#xD;
      aneurysm ruptured subarachnoid hemorrhage patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Astragalus membranaceus (AM, Huang-Chi) is a Chinese herb used extensively in China as a&#xD;
      traditional treatment to treat stroke for a long time, and a number of studies have shown&#xD;
      that AM can reduce cerebral infarction area and has anti-oxidation activity. Our previous&#xD;
      studies have demonstrated enhanced recovery of neurologic function in patients with acute&#xD;
      hemorrhagic stroke who received AM. It is hypothesized that AM either reduces inflammatory&#xD;
      response or reduces perihematomal edema.&#xD;
&#xD;
      Subarachnoid hemorrhage secondary to rupture of a cerebral aneurysm is a medical condition&#xD;
      associated with a high morbidity and mortality; approximately 10-15% of patients die before&#xD;
      reaching medical care, and overall mortality is approximately 45%. Of those that survive, 30%&#xD;
      suffer permanent disability graded as moderate to severe, and two-thirds of survivors never&#xD;
      return to the same quality of life as they had prior to their hemorrhage. A large number of&#xD;
      patients (30-70%) who are able to make it to the hospital and have successful treatment of&#xD;
      their aneurysm will develop delayed cerebral vasospasm that is related to the blood clot from&#xD;
      their initial aneurysm rupture. Of patients that survive their initial aneurysm rupture,&#xD;
      vasospasm results in an additional 7% mortality and another 7% of severe disabilities&#xD;
      secondary to ischemic strokes from severe spasm of cerebral arteries.&#xD;
&#xD;
      This research is trying to see if AM can enhance the clinical prognosis for spontaneous&#xD;
      aneurysm ruptured subarachnoid hemorrhage patients. All procedures done as a part of this&#xD;
      study are standard hospital care procedures done to treat aneurysmal subarachnoid hemorrhage&#xD;
      according to the AHA/ASA guideline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2020</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>Clinical symptom</measure>
    <time_frame>90 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage</time_frame>
    <description>evaluating recovery scale percentage at 90 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>IL-6</measure>
    <time_frame>14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage</time_frame>
    <description>Interleukin 6, IL-6 in blood and cerebrospinal fluid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IL-1β</measure>
    <time_frame>14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage</time_frame>
    <description>Interleukin 1β, IL-1β in blood and cerebrospinal fluid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TNF-α</measure>
    <time_frame>14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage</time_frame>
    <description>Tumor Necrosis Factor-α, TNF-α in blood and cerebrospinal fluid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>S100-β</measure>
    <time_frame>14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage</time_frame>
    <description>S100-β in blood and cerebrospinal fluid</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Aneurysmal Subarachnoid Hemorrhage</condition>
  <arm_group>
    <arm_group_label>AM group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment group will accept Astragalus Membranaceus(AM) t.i.w treatment for 14 days from second day of admission, in addition to standard ordinary treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Control group will accept placebo t.i.w treatment for 14 days from the second day of admission, in addition to standard ordinary treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Astragalus Membranaceus</intervention_name>
    <description>This research is trying to see if AM can enhance the clinical prognosis for spontaneous aneurysm ruptured subarachnoid hemorrhage patients.</description>
    <arm_group_label>AM group</arm_group_label>
    <other_name>Astragalus propinquus</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>as a comparator comparing with AM group</description>
    <arm_group_label>Placebo group</arm_group_label>
    <other_name>Starch</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who admitted to the hospital within 24 hours of onset of aneurysmal&#xD;
             subarachnoid hemorrhage (SAH) stroke&#xD;
&#xD;
          -  Subarachnoid hemorrhage documented on head CT&#xD;
&#xD;
          -  Hunt Hess Grade 1-4&#xD;
&#xD;
          -  Both Male and Female&#xD;
&#xD;
          -  Age more than 20 and less than 80 years older&#xD;
&#xD;
          -  Informed consent obtained from a patient or legal representative before enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Traumatic or mycotic aneurysms&#xD;
&#xD;
          -  Complication of serious heart or hepatic disease or infection or renal failure&#xD;
&#xD;
          -  Malignant tumor&#xD;
&#xD;
          -  Patients judged to be inappropriate by physician in charge&#xD;
&#xD;
          -  Pregnant / breast feeding women&#xD;
&#xD;
          -  Patients have enrolled or have not yet completed other investigational drug trials&#xD;
             within 1 month before screening&#xD;
&#xD;
          -  Ever stroke, and mRS≧3&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>China Medical University Hospital</investigator_affiliation>
    <investigator_full_name>Chun-Chung Chen</investigator_full_name>
    <investigator_title>Attending Surgeon</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Subarachnoid Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03271697
org study id: CMUH106-REC1-074
nct id: NCT03271697
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research is trying to see if AM can enhance the clinical prognosis for spontaneous
      aneurysm ruptured subarachnoid hemorrhage patients.
Astragalus membranaceus (AM, Huang-Chi) is a Chinese herb used extensively in China as a
      traditional treatment to treat stroke for a long time, and a number of studies have shown
      that AM can reduce cerebral infarction area and has anti-oxidation activity. Our previous
      studies have demonstrated enhanced recovery of neurologic function in patients with acute
      hemorrhagic stroke who received AM. It is hypothesized that AM either reduces inflammatory
      response or reduces perihematomal edema.

      Subarachnoid hemorrhage secondary to rupture of a cerebral aneurysm is a medical condition
      associated with a high morbidity and mortality; approximately 10-15% of patients die before
      reaching medical care, and overall mortality is approximately 45%. Of those that survive, 30%
      suffer permanent disability graded as moderate to severe, and two-thirds of survivors never
      return to the same quality of life as they had prior to their hemorrhage. A large number of
      patients (30-70%) who are able to make it to the hospital and have successful treatment of
      their aneurysm will develop delayed cerebral vasospasm that is related to the blood clot from
      their initial aneurysm rupture. Of patients that survive their initial aneurysm rupture,
      vasospasm results in an additional 7% mortality and another 7% of severe disabilities
      secondary to ischemic strokes from severe spasm of cerebral arteries.

      This research is trying to see if AM can enhance the clinical prognosis for spontaneous
      aneurysm ruptured subarachnoid hemorrhage patients. All procedures done as a part of this
      study are standard hospital care procedures done to treat aneurysmal subarachnoid hemorrhage
      according to the AHA/ASA guideline.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Clinical symptom
time frame: 90 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage
description: evaluating recovery scale percentage at 90 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage
measure: IL-6
time frame: 14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage
description: Interleukin 6, IL-6 in blood and cerebrospinal fluid
measure: IL-1β
time frame: 14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage
description: Interleukin 1β, IL-1β in blood and cerebrospinal fluid
measure: TNF-α
time frame: 14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage
description: Tumor Necrosis Factor-α, TNF-α in blood and cerebrospinal fluid
measure: S100-β
time frame: 14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage
description: S100-β in blood and cerebrospinal fluid
arm group label: AM group
arm group type: Experimental
description: Treatment group will accept Astragalus Membranaceus(AM) t.i.w treatment for 14 days from second day of admission, in addition to standard ordinary treatment.
arm group label: Placebo group
arm group type: Placebo Comparator
description: Control group will accept placebo t.i.w treatment for 14 days from the second day of admission, in addition to standard ordinary treatment.
intervention type: Drug
intervention name: Astragalus Membranaceus
description: This research is trying to see if AM can enhance the clinical prognosis for spontaneous aneurysm ruptured subarachnoid hemorrhage patients.
arm group label: AM group
other name: Astragalus propinquus
intervention type: Drug
intervention name: Placebo
description: as a comparator comparing with AM group
arm group label: Placebo group
other name: Starch
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: China Medical University Hospital
investigator full name: Chun-Chung Chen
investigator title: Attending Surgeon
mesh term: Subarachnoid Hemorrhage
mesh term: Hemorrhage
sharing ipd: No