Clinical Study on the Treatment of Hypertensive Intracerebral Hemorrhage With Panax Notoginseng Saponin (CSTHIHPNS)

Yangtze University

Status and phase: Completed; Phase 4

Conditions: Hematoma Absorption and Neurological Function Recovery

Treatments: Drug: Panax Notoginseng Saponins

Study type: Interventional

Funder types: Other

Identifiers

NCT02999048

2012CC47

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

control group

No Intervention group

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.

intervention group

Other group

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.

Treatment:

Drug: Panax Notoginseng Saponins