Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators conducted a randomized, double-blind, trial enrolled 60 patients within 12 hours of acute ischemic stroke (AIS) in China. Patients were randomly assigned to receive a 10-day infusion of dl-3-n-butylphthalide (NBP) or cerebrolysin, or placebo. National Institutes of Health Stroke Scale (NIHSS) and Barthel Index (BI) were used to evaluate the efficacy in the patients with AIS at 11-day and 21-day after therapy. Adverse events were also analyzed among the three groups.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dl-3-n-butylphthalide | Experimental | Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days |
|
| Cerebrolysin | Experimental | Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days |
|
| Placebo | Placebo Comparator | Intravenous infusion of 100 ml saline intravenous q.d. for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dl-3-n-butylphthalide | Drug | Intravenous infusion of 100 ml dl-3-n-butylphthalide and sodium chloride injection for 10 days, twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| National Institutes of Health Stroke Scale Score | Scores range from 0 to 42, with higher scores indicating increasing severity | At 11-day and 21-day after therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Barthel Index Score | Range from 0, indicating complete dependence on help with activities of daily living, to 100, indicating independence | At 11-day and 21-day after therapy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lixia Xue, M.D., Ph.D. | Shanghai 6th People's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Sixth People's Hospital | Shanghai | 200233 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27168844 | Derived | Xue LX, Zhang T, Zhao YW, Geng Z, Chen JJ, Chen H. Efficacy and safety comparison of DL-3-n-butylphthalide and Cerebrolysin: Effects on neurological and behavioral outcomes in acute ischemic stroke. Exp Ther Med. 2016 May;11(5):2015-2020. doi: 10.3892/etm.2016.3139. Epub 2016 Mar 10. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
From January 2010 to May 2010, a randomized, double-blind trial was conducted, which involved patients with AIS in the Neurology Ward of Shanghai Jiao Tong University Affiliated Sixth People's Hospital (Shanghai, China).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dl-3-n-butylphthalide | Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days "Dl-3-n-butylphthalide", "Cerebrolysin" and "Placebo" separately |
| FG001 | Cerebrolysin | Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days "Dl-3-n-butylphthalide", "Cerebrolysin" and "Placebo" separately |
| FG002 | Placebo | Intravenous infusion of 100 ml saline intravenous q.d. for 10 days "Dl-3-n-butylphthalide", "Cerebrolysin" and "Placebo" separately |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dl-3-n-butylphthalide | Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days. |
| BG001 | Cerebrolysin | Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | National Institutes of Health Stroke Scale Score | Scores range from 0 to 42, with higher scores indicating increasing severity | Posted | Mean | Standard Deviation | units on a scale | At 11-day and 21-day after therapy |
|
21 days
Systematic methods include a physical examination (including heart rate, blood pressure and oxygen concentration), laboratory tests (including urine test, complete blood count, occult blood test, renal function, liver function, electrolyte and blood-glucose), electrocardiogram, cranial CT or MRI and chest radiograph.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dl-3-n-butylphthalide | Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coagulation disorder | Blood and lymphatic system disorders | TESS | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythrema | Skin and subcutaneous tissue disorders | TESS | Non-systematic Assessment |
Foremost is the relatively small sample size, and only patients with moderate severity of stroke were enrolled, so the efficacy results of this study should be interpreted with caution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hao Chen | Shanghai Sixth People's Hospital | 02164369181 | 8405 | chenhao_316@aliyun.com |
Not provided
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C027125 | 3-n-butylphthalide |
| D036881 | Long-Term Synaptic Depression |
| C006952 | cerebrolysin |
| ID | Term |
|---|---|
| D009473 | Neuronal Plasticity |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cerebrolysin | Drug | Intravenous infusion of 30 ml Cerebrolysin per day in 100 ml normal saline for 10 days. |
|
|
| Placebo | Drug | 100 ml saline intravenous infusion once daily for 10 days. |
|
|
| Physician Decision |
|
| BG002 | Placebo | Intravenous infusion of 100 ml saline intravenous q.d. for 10 days. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Time until admission | Mean | Standard Deviation | hour |
|
| Time until treatment | Mean | Standard Deviation | hour |
|
| Systolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic blood pressure | Mean | Standard Deviation | mmHg |
|
| National Institutes of Health Stroke Scale score | The scores range from 0 to 42, with higher scores indicating increasing severity. A score of < 4 represented low-degree impairment, between 4 and 15 represented medium-degree impairment, and a score of > 15 represented severe-degree impairment. | Mean | Standard Deviation | units on a scale |
|
| Barthel Index score | The scores range from 0, indicating complete dependence on help with activities of daily living, to 100, indicating independence. | Mean | Standard Deviation | units on a scale |
|
|
|
| Secondary | Barthel Index Score | Range from 0, indicating complete dependence on help with activities of daily living, to 100, indicating independence | Posted | Mean | Standard Deviation | units on a scale | At 11-day and 21-day after therapy |
|
|
|
| 8 |
| 20 |
| 16 |
| 20 |
| EG001 | Cerebrolysin | Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days. | 7 | 20 | 12 | 20 |
| EG002 | Placebo | Intravenous infusion of 100 ml saline intravenous q.d. for 10 days. | 11 | 20 | 12 | 20 |
| Cardiac failure | Cardiac disorders | TESS | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | TESS | Non-systematic Assessment |
|
| Cerebral hemorrhage | Nervous system disorders | TESS | Systematic Assessment |
|
| Fever | General disorders | TESS | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | TESS | Non-systematic Assessment |
|
| Nausea/vomiting | General disorders | TESS | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | TESS | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
|