search
Back to results

Astragalus Membranaceus on Aneurysmal Subarachnoid Hemorrhage (AMASH)

Primary Purpose

Aneurysmal Subarachnoid Hemorrhage

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Astragalus Membranaceus
Placebo
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aneurysmal Subarachnoid Hemorrhage

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who admitted to the hospital within 24 hours of onset of aneurysmal subarachnoid hemorrhage (SAH) stroke
  • Subarachnoid hemorrhage documented on head CT
  • Hunt Hess Grade 1-4
  • Both Male and Female
  • Age more than 20 and less than 80 years older
  • Informed consent obtained from a patient or legal representative before enrollment

Exclusion Criteria:

  • Traumatic or mycotic aneurysms
  • Complication of serious heart or hepatic disease or infection or renal failure
  • Malignant tumor
  • Patients judged to be inappropriate by physician in charge
  • Pregnant / breast feeding women
  • Patients have enrolled or have not yet completed other investigational drug trials within 1 month before screening
  • Ever stroke, and mRS≧3

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    AM group

    Placebo group

    Arm 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.

    Control group will accept placebo t.i.w treatment for 14 days from the second day of admission, in addition to standard ordinary treatment.

    Outcomes

    Primary Outcome Measures

    Clinical symptom
    evaluating recovery scale percentage at 90 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage

    Secondary Outcome Measures

    IL-6
    Interleukin 6, IL-6 in blood and cerebrospinal fluid
    IL-1β
    Interleukin 1β, IL-1β in blood and cerebrospinal fluid
    TNF-α
    Tumor Necrosis Factor-α, TNF-α in blood and cerebrospinal fluid
    S100-β
    S100-β in blood and cerebrospinal fluid

    Full Information

    First Posted
    August 21, 2017
    Last Updated
    August 31, 2017
    Sponsor
    China Medical University Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03271697
    Brief Title
    Astragalus Membranaceus on Aneurysmal Subarachnoid Hemorrhage
    Acronym
    AMASH
    Official Title
    Efficacy Study of Astragalus Membranaceus on Aneurysmal Subarachnoid Hemorrhage
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2017 (Anticipated)
    Primary Completion Date
    September 2020 (Anticipated)
    Study Completion Date
    September 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    China Medical University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This research is trying to see if AM can enhance the clinical prognosis for spontaneous aneurysm ruptured subarachnoid hemorrhage patients.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aneurysmal Subarachnoid Hemorrhage

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    AM group
    Arm Type
    Experimental
    Arm 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 Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm 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(s)
    Astragalus Membranaceus
    Other Intervention Name(s)
    Astragalus propinquus
    Intervention Description
    This research is trying to see if AM can enhance the clinical prognosis for spontaneous aneurysm ruptured subarachnoid hemorrhage patients.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Starch
    Intervention Description
    as a comparator comparing with AM group
    Primary Outcome Measure Information:
    Title
    Clinical symptom
    Description
    evaluating recovery scale percentage at 90 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage
    Time Frame
    90 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage
    Secondary Outcome Measure Information:
    Title
    IL-6
    Description
    Interleukin 6, IL-6 in blood and cerebrospinal fluid
    Time Frame
    14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage
    Title
    IL-1β
    Description
    Interleukin 1β, IL-1β in blood and cerebrospinal fluid
    Time Frame
    14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage
    Title
    TNF-α
    Description
    Tumor Necrosis Factor-α, TNF-α in blood and cerebrospinal fluid
    Time Frame
    14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage
    Title
    S100-β
    Description
    S100-β in blood and cerebrospinal fluid
    Time Frame
    14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients who admitted to the hospital within 24 hours of onset of aneurysmal subarachnoid hemorrhage (SAH) stroke Subarachnoid hemorrhage documented on head CT Hunt Hess Grade 1-4 Both Male and Female Age more than 20 and less than 80 years older Informed consent obtained from a patient or legal representative before enrollment Exclusion Criteria: Traumatic or mycotic aneurysms Complication of serious heart or hepatic disease or infection or renal failure Malignant tumor Patients judged to be inappropriate by physician in charge Pregnant / breast feeding women Patients have enrolled or have not yet completed other investigational drug trials within 1 month before screening Ever stroke, and mRS≧3

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Astragalus Membranaceus on Aneurysmal Subarachnoid Hemorrhage

    We'll reach out to this number within 24 hrs