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Astragalus Membranaceus on Aneurysmal Subarachnoid Hemorrhage

يمكن للمستخدمين المسجلين فقط ترجمة المقالات
الدخول التسجيل فى الموقع
يتم حفظ الارتباط في الحافظة
الحالةلم يتم التجنيد بعد
الرعاة
China Medical University Hospital

الكلمات الدالة

نبذة مختصرة

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

وصف

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.

تواريخ

آخر التحقق: 07/31/2017
تم الإرسال لأول مرة: 08/20/2017
تم إرسال التسجيل المقدر: 08/30/2017
أول نشر: 09/04/2017
تم إرسال آخر تحديث: 08/30/2017
آخر تحديث تم نشره: 09/04/2017
تاريخ بدء الدراسة الفعلي: 08/31/2017
تاريخ الإنجاز الأساسي المقدر: 08/31/2020
التاريخ المتوقع لانتهاء الدراسة: 08/31/2020

حالة أو مرض

Aneurysmal Subarachnoid Hemorrhage

التدخل / العلاج

Drug: AM group

Drug: Placebo group

مرحلة

مرحلة 2/مرحلة 3

مجموعات الذراع

ذراعالتدخل / العلاج
Experimental: AM group
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: AM group
This research is trying to see if AM can enhance the clinical prognosis for spontaneous aneurysm ruptured subarachnoid hemorrhage patients.
Placebo Comparator: Placebo group
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 group
as a comparator comparing with AM group

معايير الأهلية

الأعمار المؤهلة للدراسة 20 Years إلى 20 Years
الأجناس المؤهلة للدراسةAll
يقبل المتطوعين الأصحاءنعم
المعايير

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

النتيجة

مقاييس النتائج الأولية

1. Clinical symptom [90 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage]

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

مقاييس النتائج الثانوية

1. IL-6 [14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage]

Interleukin 6, IL-6 in blood and cerebrospinal fluid

2. IL-1β [14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage]

Interleukin 1β, IL-1β in blood and cerebrospinal fluid

3. TNF-α [14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage]

Tumor Necrosis Factor-α, TNF-α in blood and cerebrospinal fluid

4. S100-β [14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage]

S100-β in blood and cerebrospinal fluid

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