StrokePhase 2NCT01428401
Astragalus Membranaceus for Brain Edema Induced by Hemorrhagic Stroke
A Phase 2 study testing Chinese Herb Astragalus membranaceus in people with Stroke and Hemorrhagic Transformation Due to Acute Stroke, run by China Medical University Hospital.
Trial summary
Astragalus membranaceus (AM) is used to treat stroke for a long period, and a number of studies have known that AM can reduce cerebral infarction area and has anti-oxidation. Hemorrhagic stroke will induce secondary peri-blood clot edema and that may increase intracranial pressure to exacerbate clinical symptom. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Stroke, Hemorrhagic Transformation Due to Acute Stroke
- What is being tested?
- Chinese Herb Astragalus membranaceus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Mar 2011
- Phase
- Phase 2
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female or male;
- aged between 30 and 75 years;
- randomized allocation to a study group within 24 hours of hemorrhagic stroke onset;
- this was the patient's first hemorrhagic stroke, and the location of hemorrhage was the putamen;
- treatment may or may not have been included surgery; and
- the subject or their legal representative gave written informed consent to participate.
Who cannot join
- recent thrombolysis treatment;
- history of previous stroke;
- full-dose or long-term anti-coagulation therapy;
- hemorrhagic stroke but the location was not putamen;
- coexisting systemic diseases such as terminal cancer, renal failure, liver cirrhosis, severe dementia, or psychosis;
- participation in another clinical trial within the last three months; and
- pregnancy or lactation.
About this study
Astragalus membranaceus (AM) is used to treat stroke for a long period, and a number of studies have known that AM can reduce cerebral infarction area and has anti-oxidation. Hemorrhagic stroke will induce secondary peri-blood clot edema and that may increase intracranial pressure to exacerbate clinical symptom. Therefore, the purpose of the present study was to investigate the effect of AM on hemorrhagic stroke edema. The investigators selected 80 hemorrhagic stroke patients , and who the stroke is first attack, they were randomly divided into control and experimental groups, and each group was 40 patients as follows: 1) control group, accepted AM placebo 2.8 g three times per day (tid) treatment for continuously 14 days from second day of admission or operation, except standard ordinary treatment; 2) experimental group, accepted AM 2.8 g tid treatment for continuously 14 days from second day of admission or operation, except standard ordinary treatment. Computer tomography (CT) examination was done at first day, 4th day and 7th day of admission, respectively. The ratio of brain edema was calculated by CT image, and inflammatory index including the levels of C-reactive protein (CRP), erythrocyte sedimentation rate (ESR)，Creatine Kinase BB Isoenzyme (CMBB). D-dimer from venous blood also were measured. In addition, the score including Glasgow outcome scale (GOS), Modified rankin scale (MRS), Function independence measure (FIM), Barthel index (BI) was recorded one week, four weeks and 12 weeks after admission or surgical operation, as an index for clinical symptoms. The index for the therapeutic effect of AM was according to above-mentioned the ratio of brain edema, inflammatory index and clinical symptoms.
The investigators expected the results of the present study may provide a scientific evidence for the hemorrhagic stroke edema treatment of AM, thus, the present study may contribute to use the method of integrated Chinese and Western Medicine for the treatment of stroke, and to the research of Chinese Medicine.
- Being tested
- Chinese Herb Astragalus membranaceus, Placebo
- Keywords
- Complementary therapies, Acute hemorrhagic stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese Herb Astragalus membranaceusDrug
Astragalus membranaceus ( AM) at a rate of 3 g three times per day
PlaceboOther
at a rate of 3 g three times per day
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: Chinese Herb Astragalus membranaceus |
| Arm B | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
patients' scores(BI,FIM,GOS,mRS) on several clinical scales
The primary outcome measures were the differences in patients' scores on several clinical scales, between baseline (within 7 ± 1 days after the onset of stroke) and week 4 (28 ± 4 days), and between at baseline and week 12 (84 ± 10 days). The scales we used were the Functional Independence Measure scale (FIM), Barthel Index scale (BI), Glasgow Outcome Scale (GOS), and Modified Rankin Scale (MRS). The scores of FIM, BI, GOS, and MRS were assessed by an experienced research nurse.
Measured: baseline (within 7 ± 1 days after the onset of stroke) and week 4 (28 ± 4 days), and between at baseline and week 12 (84 ± 10 days).
Secondary outcomes (1)
inflammatory index and Computer tomography (CT) examination
- inflammatory index, which included the levels of C-reactive protein (CRP) and erythrocyte sediment rate (ESR) for venous blood; these were measured at baseline (prior to the first AM dose), and again on the fourth and seventh day of admission; and
- Computer tomography (CT) examination, which was done at baseline and on the fourth and seventh days of admission. The ratio of brain edema was calculated by CT (volume of edema divided by blood clot volume)
Measured: at baseline (prior to the first AM dose), and again on the fourth and seventh day of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2011 (estimated)
- Study startJan 2008
- Primary completionDec 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun Chung Chen, master, Principal investigator, d6407@mail.cmuh.org.tw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428401
- Sponsor's protocol ID
- DMR96-IRB-126
- Status last verified
- Sep 2011
- First submitted
- 1 Sep 2011
- Last updated
- 5 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Astragalus Membranaceus for Brain Edema Induced by Hemorrhagic Stroke
- ClinicalTrials.gov ID
- NCT01428401
- Acronym / sponsor ID
- DMR96-IRB-126
- Keywords
- Complementary therapies, Acute hemorrhagic stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 5 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Astragalus membranaceus (AM) is used to treat stroke for a long period, and a number of studies have known that AM can reduce cerebral infarction area and has anti-oxidation. Hemorrhagic stroke will induce secondary peri-blood clot edema and that may increase intracranial pressure to exacerbate clinical symptom. Therefore, the purpose of the present study was to investigate the effect of AM on hemorrhagic stroke edema. The investigators selected 80 hemorrhagic stroke patients , and who the stroke is first attack, they were randomly divided into control and experimental groups, and each group was 40 patients as follows: 1) control group, accepted AM placebo 2.8 g three times per day (tid) treatment for continuously 14 days from second day of admission or operation, except standard ordinary treatment; 2) experimental group, accepted AM 2.8 g tid treatment for continuously 14 days from second day of admission or operation, except standard ordinary treatment. Computer tomography (CT) examination was done at first day, 4th day and 7th day of admission, respectively. The ratio of brain edema was calculated by CT image, and inflammatory index including the levels of C-reactive protein (CRP), erythrocyte sedimentation rate (ESR)，Creatine Kinase BB Isoenzyme (CMBB). D-dimer from venous blood also were measured. In addition, the score including Glasgow outcome scale (GOS), Modified rankin scale (MRS), Function independence measure (FIM), Barthel index (BI) was recorded one week, four weeks and 12 weeks after admission or surgical operation, as an index for clinical symptoms. The index for the therapeutic effect of AM was according to above-mentioned the ratio of brain edema, inflammatory index and clinical symptoms.
The investigators expected the results of the present study may provide a scientific evidence for the hemorrhagic stroke edema treatment of AM, thus, the present study may contribute to use the method of integrated Chinese and Western Medicine for the treatment of stroke, and to the research of Chinese Medicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Chinese Herb Astragalus membranaceus |
| Arm B | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- female or male;
- aged between 30 and 75 years;
- randomized allocation to a study group within 24 hours of hemorrhagic stroke onset;
- this was the patient's first hemorrhagic stroke, and the location of hemorrhage was the putamen;
- treatment may or may not have been included surgery; and
Key exclusion criteria (7 listed)
- recent thrombolysis treatment;
- history of previous stroke;
- full-dose or long-term anti-coagulation therapy;
- hemorrhagic stroke but the location was not putamen;
- coexisting systemic diseases such as terminal cancer, renal failure, liver cirrhosis, severe dementia, or psychosis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese Herb Astragalus membranaceusAstragalus membranaceus ( AM) at a rate of 3 g three times per day | Drug | Arm A |
| Placeboat a rate of 3 g three times per day | Other | Arm B |
Primary outcome
patients' scores(BI,FIM,GOS,mRS) on several clinical scales
Time frame: baseline (within 7 ± 1 days after the onset of stroke) and week 4 (28 ± 4 days), and between at baseline and week 12 (84 ± 10 days).
The primary outcome measures were the differences in patients' scores on several clinical scales, between baseline (within 7 ± 1 days after the onset of stroke) and week 4 (28 ± 4 days), and between at baseline and week 12 (84 ± 10 days). The scales we used were the Functional Independence Measure scale (FIM), Barthel Index scale (BI), Glasgow Outcome Scale (GOS), and Modified Rankin Scale (MRS). The scores of FIM, BI, GOS, and MRS were assessed by an experienced research nurse.
1 secondary outcome
inflammatory index and Computer tomography (CT) examination
Time frame: at baseline (prior to the first AM dose), and again on the fourth and seventh day of admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun Chung Chen, master principal investigator
d6407@mail.cmuh.org.tw
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chinese Herb Astragalus membranaceus in people with Stroke and Hemorrhagic Transformation Due to Acute Stroke, 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: finished, as of the sponsor's last update on 5 Sep 2011. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
patients' scores(BI,FIM,GOS,mRS) on several clinical scales (time frame: baseline (within 7 ± 1 days after the onset of stroke) and week 4 (28 ± 4 days), and between at baseline and week 12 (84 ± 10 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2011.