Clinical trial NCT02999048: Clinical Study on the Treatment of Hypertensive Intracerebral Hemorrhage With Panax Notoginseng Saponin
Official title: Clinical Study on the Treatment of Hypertensive Cerebral Hemorrhage With Panax Notoginseng Saponins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hematoma Absorption and Neurological Function Recovery
Keywords: panax notoginseng saponins
hypertensive intracerebral hemorrhage
hematoma
neurological function
Lead sponsor: The First People's Hospital of Jingzhou
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether panax notoginseng saponins are effective in the treatment of Hypertensive Intracerebral Hemorrhage Patients.

Detailed description: Patients with HICH were randomly assigned to receive either PNS integrated with conventional therapy. Patients were treated with conventional therapy for 3 days, then plus PNS for 14 days. Patients in the control group received conventional therapy for 17days. Hematoma volume measured by CT scanning, National Institutes of Health Stroke Scale (NIHSS) scores, Barthel index (BI), all the three were used to evaluate the therapeutic effect for both groups after two weeks of intervention.

Eligibility criteria: 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.

Primary outcomes:
measure: Hematoma volume
timeFrame: within the 14 days after two weeks of intervention
measure: National Institutes of Health Stroke Scale (NIHSS) scores
timeFrame: within the 14 days after two weeks of intervention
measure: Barthel index
timeFrame: within the 14 days after two weeks of intervention
Secondary outcomes:
measure: adverse events
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
References:
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