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
About this trial
This is an interventional treatment trial for Aneurysmal Subarachnoid Hemorrhage
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
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
NCT ID
NCT03271697
First Posted
August 21, 2017
Last Updated
August 31, 2017
Sponsor
China Medical University Hospital
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
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