Astragalus Membranaceus on Aneurysmal Subarachnoid Hemorrhage

Aneurysmal Subarachnoid Hemorrhage Clinical Trial

— AMASH  

Official title:

Efficacy Study of Astragalus Membranaceus on Aneurysmal Subarachnoid Hemorrhage

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03271697
• Other study ID #: CMUH106-REC1-074
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: August 21, 2017
• Last updated: August 31, 2017
• Start date: September 2017
• Est. completion date: September 2020

Study information

• Verified date: August 2017
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Hemorrhage
• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Drug:
• Astragalus Membranaceus
This research is trying to see if AM can enhance the clinical prognosis for spontaneous aneurysm ruptured subarachnoid hemorrhage patients.
• Placebo
as a comparator comparing with AM group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	IL-6	Interleukin 6, IL-6 in blood and cerebrospinal fluid	14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage
Secondary	IL-1ß	Interleukin 1ß, IL-1ß in blood and cerebrospinal fluid	14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage
Secondary	TNF-a	Tumor Necrosis Factor-a, TNF-a in blood and cerebrospinal fluid	14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage
Secondary	S100-ß	S100-ß in blood and cerebrospinal fluid	14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage