Hematoma Absorption and Neurological Function Recovery Clinical Trial
— CSTHIHPNSOfficial title:
Clinical Study on the Treatment of Hypertensive Cerebral Hemorrhage With Panax Notoginseng Saponins
| Verified date | December 2016 |
| Source | The First People's Hospital of Jingzhou |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Ethics Committee |
| Study type | Interventional |
The purpose of this study is to determine whether panax notoginseng saponins are effective in the treatment of Hypertensive Intracerebral Hemorrhage Patients.
| Status | Completed |
| Enrollment | 90 |
| Est. completion date | May 2016 |
| Est. primary completion date | May 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - with a history of hypertension treated with medication and blood pressure management ( a systolic blood-pressure target of 140 to 179 mmHg and a diastolic blood-pressure target of 70 to 100 mmHg) during the period of hospitalization, - the site of hematoma located in one of the cerebral hemispheres, - hematoma volume 10-30ml, - no blood in the ventricles, - within 24 hours of onset of first-time acute intracerebral hemorrhage, - no loss of consciousness (drowsiness acceptable). Exclusion Criteria: - cerebellar or brainstem hemorrhage, - intracerebral hemorrhage caused by bleeding diathesis, aneurysms, vascular malformations, improperly using anticoagulant drugs, or suspicious amyloid angiopathy, - subarachnoid hemorrhage; multifocal hemorrhage, - mixed stroke or hemorrhagic infarct, - coexisting systematic diseases such as heart or kidney failure, tumors, gastrointestinal hemorrhage and so on, - pregnant or lactating women, - a history of XUESAITONG injection anaphylaxis. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| The First People's Hospital of Jingzhou |
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* Note: There are 13 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Hematoma volume | within the 14 days after two weeks of intervention | No | |
| Primary | National Institutes of Health Stroke Scale (NIHSS) scores | were measured for stroke severity | within the 14 days after two weeks of intervention | No |
| Primary | Barthel index | were measured for quality of life | within the 14 days after two weeks of intervention | No |
| Secondary | adverse events | such as rash, allergic shock | 14 days | Yes |