Astragalus Membranaceus on Aneurysmal Subarachnoid Hemorrhage

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

Detailed Description
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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.

Official Title
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Efficacy Study of Astragalus Membranaceus on Aneurysmal Subarachnoid Hemorrhage

Conditions
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Aneurysmal Subarachnoid Hemorrhage

Intervention / Treatment
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* Drug: Astragalus Membranaceus
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AM group<br>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. | Drug: Astragalus Membranaceus<br>* This research is trying to see if AM can enhance the clinical prognosis for spontaneous aneurysm ruptured subarachnoid hemorrhage patients.<br>* Other names: Astragalus propinquus;|
| Placebo Comparator: Placebo group<br>Control group will accept placebo t.i.w treatment for 14 days from the second day of admission, in addition to standard ordinary treatment. | Drug: Placebo<br>* as a comparator comparing with AM group<br>* Other names: Starch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical symptom | evaluating recovery scale percentage at 90 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage | 90 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-6 | Interleukin 6, IL-6 in blood and cerebrospinal fluid | 14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage | 
| IL-1β | Interleukin 1β, IL-1β in blood and cerebrospinal fluid | 14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage | 
| TNF-α | Tumor Necrosis Factor-α, TNF-α in blood and cerebrospinal fluid | 14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage | 
| S100-β | S100-β in blood and cerebrospinal fluid | 14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage |