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Hematoma Absorption and Neurological Function RecoveryPhase 4CSTHIHPNSNCT02999048

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

A Phase 4 study testing Panax Notoginseng Saponins in people with Hematoma Absorption and Neurological Function Recovery, run by The First People's Hospital of Jingzhou.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 50 to 80 years
What is being tested?
Panax Notoginseng Saponins
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
No sites listed yet
Study dates
May 2014to May 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

About this study

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

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.

Being tested
Panax Notoginseng Saponins
Keywords
panax notoginseng saponins, hypertensive intracerebral hemorrhage, hematoma, neurological function
Medical subject headings
Intracranial Hemorrhage, Hypertensive, Hematoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Panax Notoginseng SaponinsDrug

    Also called XUESAITONG Injection

    Panax Notoginseng Saponins integrated with conventional therapy

Study groups in NCT02999048
Study groupRoleWhat they receive
control groupNo interventionPatients 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 groupOtherPatients 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.
Receives: Drug: Panax Notoginseng Saponins

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hematoma volume

    Measured: within the 14 days after two weeks of intervention

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

    were measured for stroke severity

    Measured: within the 14 days after two weeks of intervention

  3. Barthel index

    were measured for quality of life

    Measured: within the 14 days after two weeks of intervention

Secondary outcomes (1)

  1. adverse events

    such as rash, allergic shock

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2016 (estimated)
  2. Study startMay 2014
  3. Primary completionMay 2016
  4. Study completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02999048
Sponsor's protocol ID
2012CC47
Acronym
CSTHIHPNS
Status last verified
Dec 2016
First submitted
13 Dec 2016
Last updated
21 Dec 2016
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Panax Notoginseng Saponins in people with Hematoma Absorption and Neurological Function Recovery, run by The First People's Hospital of Jingzhou.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hematoma volume (time frame: within the 14 days after two weeks of intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02999048, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2016.

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