Astragalus Membranaceus on Aneurysmal Subarachnoid Hemorrhage (AMASH)

Efficacy Study of Astragalus Membranaceus on Aneurysmal Subarachnoid Hemorrhage

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

Study Overview

• Status: Unknown
• Conditions: Aneurysmal Subarachnoid Hemorrhage
• Intervention / Treatment: Drug: Astragalus Membranaceus; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Astragalus Membranaceus; This research is trying to see if AM can enhance the clinical prognosis for spontaneous aneurysm ruptured subarachnoid hemorrhage patients.; Other Names: Astragalus propinquus
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; as a comparator comparing with AM group; Other Names: Starch

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2017
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: August 31, 2017
• First Posted (Actual): September 5, 2017

Study Record Updates

• Last Update Posted (Actual): September 5, 2017
• Last Update Submitted That Met QC Criteria: August 31, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Subarachnoid Hemorrhage
• Other Study ID Numbers: CMUH106-REC1-074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No