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CompletedNCT02999048CSTHIHPNSUpdated Dec 21, 2016

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

A Phase 4 interventional study of Panax Notoginseng Saponins in Hematoma Absorption and Neurological Function Recovery, sponsored by The First People's Hospital of Jingzhou. Completed. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-12-21.

Sponsored by The First People's Hospital of Jingzhou · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

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Conditions studied

  • Hematoma Absorption and Neurological Function Recovery

Keywords

  • panax notoginseng saponins
  • hypertensive intracerebral hemorrhage
  • hematoma
  • neurological function
03

In context

Intracranial Hemorrhage, Hypertensive

25 studies on the registry are indexed under Intracranial Hemorrhage, Hypertensive; 8 are open to participants now.

This study's enrollment of 90 is below the median of 306 across 19 interventional studies indexed under Intracranial Hemorrhage, Hypertensive.

Browse Intracranial Hemorrhage, Hypertensive studies →

Lead sponsor

The First People's Hospital of Jingzhou is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • No intervention
    control group

    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.

  • Other
    intervention group

    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.

    Drug: Panax Notoginseng Saponins

Interventions

  • DrugPanax Notoginseng Saponins

    Panax Notoginseng Saponins integrated with conventional therapy

    Also known as: XUESAITONG Injection

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What researchers measure

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

    were measured for stroke severity

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

  3. Barthel index

    were measured for quality of life

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

Secondary outcomes

  1. adverse events

    such as rash, allergic shock

    Time frame: 14 days

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Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Cheung RT. Update on medical and surgical management of intracerebral hemorrhage. Rev Recent Clin Trials. 2007 Sep;2(3):174-81. doi: 10.2174/157488707781662751. PubMed 18474003 ↗
  • Nilsson OG, Lindgren A, Brandt L, Saveland H. Prediction of death in patients with primary intracerebral hemorrhage: a prospective study of a defined population. J Neurosurg. 2002 Sep;97(3):531-6. doi: 10.3171/jns.2002.97.3.0531. PubMed 12296635 ↗
  • Zhao X, Wang Y, Wang C, Li S, Wang Y, Yang Z. Quantitative evaluation for secondary injury to perihematoma of hypertensive cerebral hemorrhage by functional MR and correlation analysis with ischemic factors. Neurol Res. 2006 Jan;28(1):66-70. doi: 10.1179/016164106X91898. PubMed 16464365 ↗
  • Kang DW, Han MK, Kim HJ, Yun SC, Jeon SB, Bae HJ, Kwon SU, Kim JS. New ischemic lesions coexisting with acute intracerebral hemorrhage. Neurology. 2012 Aug 28;79(9):848-55. doi: 10.1212/WNL.0b013e3182648a79. Epub 2012 Jul 25. PubMed 22843271 ↗
  • Li JY, Yuan LX, Zhang GM, Zhou L, Gao Y, Li QB, Chen C. Activating blood circulation to remove stasis treatment of hypertensive intracerebral hemorrhage: A multi-center prospective randomized open-label blinded-endpoint trial. Chin J Integr Med. 2016 May;22(5):328-34. doi: 10.1007/s11655-016-2467-7. Epub 2016 Apr 30. PubMed 27338955 ↗
  • Chen X, Zhou M, Li Q, Yang J, Zhang Y, Zhang D, Kong S, Zhou D, He L. Sanchi for acute ischaemic stroke. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD006305. doi: 10.1002/14651858.CD006305.pub2. PubMed 18843711 ↗
  • Zhang X, Wu J, Zhang B. Xuesaitong injection as one adjuvant treatment of acute cerebral infarction: a systematic review and meta-analysis. BMC Complement Altern Med. 2015 Feb 27;15:36. doi: 10.1186/s12906-015-0560-4. PubMed 25888429 ↗
  • Kim CH, Kim JS. Development of cerebral infarction shortly after intracerebral hemorrhage. Eur Neurol. 2007;57(3):145-9. doi: 10.1159/000098465. Epub 2007 Jan 10. PubMed 17213720 ↗
  • Nyquist P. Management of acute intracranial and intraventricular hemorrhage. Crit Care Med. 2010 Mar;38(3):946-53. doi: 10.1097/CCM.0b013e3181d16a04. PubMed 20068459 ↗
  • Wasserman JK, Zhu X, Schlichter LC. Evolution of the inflammatory response in the brain following intracerebral hemorrhage and effects of delayed minocycline treatment. Brain Res. 2007 Nov 14;1180:140-54. doi: 10.1016/j.brainres.2007.08.058. Epub 2007 Sep 5. PubMed 17919462 ↗
  • Sun K, Wang CS, Guo J, Liu YY, Wang F, Liu LY, He JG, Fan JY, Han JY. Effect of Panax notoginseng saponins on lipopolysaccharide-induced adhesion of leukocytes in rat mesenteric venules. Clin Hemorheol Microcirc. 2006;34(1-2):103-8. PubMed 16543624 ↗
  • Wang YX, Yan A, Ma ZH, Wang Z, Zhang B, Ping JL, Zhu JS, Zhou Y, Dai L. Nuclear factor-kappaB and apoptosis in patients with intracerebral hemorrhage. J Clin Neurosci. 2011 Oct;18(10):1392-5. doi: 10.1016/j.jocn.2010.11.039. Epub 2011 Jul 22. PubMed 21782444 ↗
  • Li H, Deng CQ, Chen BY, Zhang SP, Liang Y, Luo XG. Total saponins of Panax notoginseng modulate the expression of caspases and attenuate apoptosis in rats following focal cerebral ischemia-reperfusion. J Ethnopharmacol. 2009 Jan 30;121(3):412-8. doi: 10.1016/j.jep.2008.10.042. Epub 2008 Nov 18. PubMed 19059471 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02999048
Lead sponsor
The First People's Hospital of Jingzhou
Responsible party
Zhijian Luo (deputy chief physician, neurology physician, The First People's Hospital of Jingzhou) — Principal investigator
First posted
Dec 21, 2016
Start date
May 2014
Primary completion
May 2016
Completion
May 2016
Last update
Dec 21, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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