Astragalus Membranaceus on Aneurysmal Subarachnoid Hemorrhage

NCT03271697 | Unknown Phase 2

• 1 other identifier: CMUH106-REC1-074
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Aneurysmal Subarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• IL-6

  14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage

• IL-1β

  14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage

• TNF-α

  14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage

• S100-β

  14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage

Study Arms (2)

AM group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

Astragalus Membranaceus DRUG

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

Also known as: Astragalus propinquus

AM group

Placebo DRUG

as a comparator comparing with AM group

Also known as: Starch

Placebo group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Huang Qi; Starch

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Surgeon

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: September 5, 2017
• Study Start: September 1, 2017
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: September 5, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share