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

NCT02999048 | Completed Phase 4 DMC

• 1 other identifier: 2012CC47
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hematoma Absorption and Neurological Function Recovery

Keywords

panax notoginseng saponins; hypertensive intracerebral hemorrhage; hematoma; neurological function

Outcome Measures

Primary Outcomes (3)

• Hematoma volume

  within the 14 days after two weeks of intervention

• National Institutes of Health Stroke Scale (NIHSS) scores

  were measured for stroke severity

  within the 14 days after two weeks of intervention

• Barthel index

  were measured for quality of life

  within the 14 days after two weeks of intervention

Secondary Outcomes (1)

• adverse events

  14 days

Study Arms (2)

control group

NO INTERVENTION

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

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

Panax Notoginseng Saponins DRUG

Panax Notoginseng Saponins integrated with conventional therapy

Also known as: XUESAITONG Injection

intervention group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First People's Hospital of Jingzhou: lead

Related Publications (13)

• 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.

  PMID: 18474003 RESULT

• 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.

  PMID: 12296635 RESULT

• 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.

  PMID: 16464365 RESULT

• 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.

  PMID: 22843271 RESULT

• 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.

  PMID: 27338955 RESULT

• 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.

  PMID: 18843711 RESULT

• 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.

  PMID: 25888429 RESULT

• 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.

  PMID: 17213720 RESULT

• Nyquist P. Management of acute intracranial and intraventricular hemorrhage. Crit Care Med. 2010 Mar;38(3):946-53. doi: 10.1097/CCM.0b013e3181d16a04.

  PMID: 20068459 RESULT

• 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.

  PMID: 17919462 RESULT

• 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.

  PMID: 16543624 RESULT

• 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.

  PMID: 21782444 RESULT

• 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.

  PMID: 19059471 RESULT

MeSH Terms

Conditions

Intracranial Hemorrhage, Hypertensive; Hematoma

Interventions

xuesetong

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: deputy chief physician, neurology physician

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 21, 2016
• Study Start: May 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: December 21, 2016

Record last verified: 2016-12