AzTrials
AzTrials

Aneurysmal Subarachnoid HemorrhagePhase 2/3AMASHNCT03271697

Astragalus Membranaceus on Aneurysmal Subarachnoid Hemorrhage

A Phase 2/3 study testing Astragalus Membranaceus in people with Aneurysmal Subarachnoid Hemorrhage, run by China Medical University Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Aneurysmal Subarachnoid Hemorrhage
What is being tested?
Astragalus Membranaceus
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
No sites listed yet
Study dates
Sep 2017to Sep 2020
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official title: 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.

Read the 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.

Being tested
Astragalus Membranaceus, Placebo
Medical subject headings
Subarachnoid Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Astragalus MembranaceusDrug

    Also called Astragalus propinquus

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

  • PlaceboDrug

    Also called Starch

    as a comparator comparing with AM group

Study groups in NCT03271697
Study groupRoleWhat they receive
AM groupExperimentalTreatment group will accept Astragalus Membranaceus(AM) t.i.w treatment for 14 days from second day of admission, in addition to standard ordinary treatment.
Receives: Drug: Astragalus Membranaceus
Placebo groupPlacebo comparatorControl group will accept placebo t.i.w treatment for 14 days from the second day of admission, in addition to standard ordinary treatment.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical symptom

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

    Measured: 90 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage

Secondary outcomes (4)

  1. IL-6

    Interleukin 6, IL-6 in blood and cerebrospinal fluid

    Measured: 14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage

  2. IL-1β

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

    Measured: 14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage

  3. TNF-α

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

    Measured: 14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage

  4. S100-β

    S100-β in blood and cerebrospinal fluid

    Measured: 14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2017
  2. Study startSep 2017 (estimated)
  3. Primary completionSep 2020 (estimated)
  4. Study completionSep 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03271697
Sponsor's protocol ID
CMUH106-REC1-074
Acronym
AMASH
Status last verified
Aug 2017
First submitted
21 Aug 2017
Last updated
5 Sep 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Astragalus Membranaceus in people with Aneurysmal Subarachnoid Hemorrhage, run by China Medical University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical symptom (time frame: 90 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03271697.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in