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Completed

NCT Number: NCT02999048

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Panax Notoginseng Saponins

Drug

Panax Notoginseng Saponins integrated with conventional therapy

Other names: XUESAITONG Injection

Primary outcomes

  1. Hematoma volume

    Time frame: within the 14 days after two weeks of intervention

  2. National Institutes of Health Stroke Scale (NIHSS) scores

    Time frame: within the 14 days after two weeks of intervention

    were measured for stroke severity

  3. Barthel index

    Time frame: within the 14 days after two weeks of intervention

    were measured for quality of life

Secondary outcomes

  1. adverse events

    Time frame: 14 days

    such as rash, allergic shock

Sponsors and collaborators

Lead sponsor

The First People's Hospital of Jingzhou

Other

Registry information

Official study title

Clinical Study on the Treatment of Hypertensive Cerebral Hemorrhage With Panax Notoginseng Saponins

Acronym: CSTHIHPNS

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 21, 2016
Registry last updated
Dec 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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