Back to resultsClinical Study on the Treatment of Hypertensive Intracerebral Hemorrhage With Panax Notoginseng Saponin (CSTHIHPNS)
Primary Purpose
Hematoma Absorption and Neurological Function Recovery
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Panax Notoginseng Saponins
Sponsored by
About this trial
This is an interventional treatment trial for Hematoma Absorption and Neurological Function Recovery focused on measuring panax notoginseng saponins, hypertensive intracerebral hemorrhage, hematoma, neurological function
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
control group
intervention group
Arm Description
Patients in the control group received conventional therapy for 17 days.conventional therapy consists of: (1) dehydration therapy by 20%mannitol (Tianjin Bane Medical Drugs Ltd., Co., China.) with the dosage from 125 to 250 ml every 8 h for 7 days depending on their clinically presumed intracranial pressure, (2) therapy to deal with complications including glucose-lowering treatment for hyperglycemia, antihypertensive treatment for hypertension, anti-inflammatory treatment for infection, acid inhibitor for peptic ulcer, and (3) supportive therapy, such as physical cooling, nutritional support, fluid, and electrolyte balance, which was provided as needed.
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.
Outcomes
Primary Outcome Measures
Hematoma volume
National Institutes of Health Stroke Scale (NIHSS) scores
were measured for stroke severity
Barthel index
were measured for quality of life
Secondary Outcome Measures
adverse events
such as rash, allergic shock
Full Information
NCT ID
NCT02999048
First Posted
December 13, 2016
Last Updated
December 16, 2016
Sponsor
The First People's Hospital of Jingzhou
1. Study Identification
Unique Protocol Identification Number
NCT02999048
Brief Title
Clinical Study on the Treatment of Hypertensive Intracerebral Hemorrhage With Panax Notoginseng Saponin
Acronym
CSTHIHPNS
Official Title
Clinical Study on the Treatment of Hypertensive Cerebral Hemorrhage With Panax Notoginseng Saponins
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First People's Hospital of Jingzhou
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematoma Absorption and Neurological Function Recovery
Keywords
panax notoginseng saponins, hypertensive intracerebral hemorrhage, hematoma, neurological function
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
Patients in the control group received conventional therapy for 17 days.conventional therapy consists of: (1) dehydration therapy by 20%mannitol (Tianjin Bane Medical Drugs Ltd., Co., China.) with the dosage from 125 to 250 ml every 8 h for 7 days depending on their clinically presumed intracranial pressure, (2) therapy to deal with complications including glucose-lowering treatment for hyperglycemia, antihypertensive treatment for hypertension, anti-inflammatory treatment for infection, acid inhibitor for peptic ulcer, and (3) supportive therapy, such as physical cooling, nutritional support, fluid, and electrolyte balance, which was provided as needed.
Arm Title
intervention group
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Panax Notoginseng Saponins
Other Intervention Name(s)
XUESAITONG Injection
Intervention Description
Panax Notoginseng Saponins integrated with conventional therapy
Primary Outcome Measure Information:
Title
Hematoma volume
Time Frame
within the 14 days after two weeks of intervention
Title
National Institutes of Health Stroke Scale (NIHSS) scores
Description
were measured for stroke severity
Time Frame
within the 14 days after two weeks of intervention
Title
Barthel index
Description
were measured for quality of life
Time Frame
within the 14 days after two weeks of intervention
Secondary Outcome Measure Information:
Title
adverse events
Description
such as rash, allergic shock
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Citations:
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Citation
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Clinical Study on the Treatment of Hypertensive Intracerebral Hemorrhage With Panax Notoginseng Saponin
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