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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02999048
Other study ID # 2012CC47
Secondary ID
Status Completed
Phase Phase 4
First received December 13, 2016
Last updated December 16, 2016
Start date May 2014
Est. completion date May 2016

Study information

Verified date December 2016
Source The First People's Hospital of Jingzhou
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 80 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Panax Notoginseng Saponins
Panax Notoginseng Saponins integrated with conventional therapy

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The First People's Hospital of Jingzhou

References & Publications (13)

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. Review. — View Citation

Cheung RT. Update on medical and surgical management of intracerebral hemorrhage. Rev Recent Clin Trials. 2007 Sep;2(3):174-81. Review. — View Citation

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. — View Citation

Kim CH, Kim JS. Development of cerebral infarction shortly after intracerebral hemorrhage. Eur Neurol. 2007;57(3):145-9. — View Citation

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: 10.1 — View Citation

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; — View Citation

Nilsson OG, Lindgren A, Brandt L, Säveland 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. — View Citation

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

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. — View Citation

Wang YX, Yan A, Ma ZH, Wang Z, Zhang B, Ping JL, Zhu JS, Zhou Y, Dai L. Nuclear factor-?B and apoptosis in patients with intracerebral hemorrhage. J Clin Neurosci. 2011 Oct;18(10):1392-5. doi: 10.1016/j.jocn.2010.11.039. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Hematoma volume within the 14 days after two weeks of intervention No
Primary National Institutes of Health Stroke Scale (NIHSS) scores were measured for stroke severity within the 14 days after two weeks of intervention No
Primary Barthel index were measured for quality of life within the 14 days after two weeks of intervention No
Secondary adverse events such as rash, allergic shock 14 days Yes