Clinical Study on the Treatment of Hypertensive Intracerebral Hemorrhage With Panax Notoginseng Saponin
Phase 4
Completed
- Conditions
- Hematoma Absorption and Neurological Function Recovery
- Interventions
- Drug: Panax Notoginseng Saponins
- Registration Number
- NCT02999048
- Lead Sponsor
- The First People's Hospital of Jingzhou
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intervention group Panax Notoginseng Saponins Patients in the intervention group received the same conventional therapy as in the control group for 3 days, brain CT was re-scanned at the 4th day, and was then given conventional therapy plus XUESAITONG Injection,which was mainly composed of Panax notoginseng saponins for 14 days from the 4th day.
- Primary Outcome Measures
Name Time Method Hematoma volume within the 14 days after two weeks of intervention Barthel index within the 14 days after two weeks of intervention were measured for quality of life
National Institutes of Health Stroke Scale (NIHSS) scores within the 14 days after two weeks of intervention were measured for stroke severity
- Secondary Outcome Measures
Name Time Method adverse events 14 days such as rash, allergic shock