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Clinical Application and Basic Study of Medicinal Fractions-based Herbal Combinations

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Dongfang Hospital
Sponsor:
Collaborators:
Shandong University of Traditional Chinese Medicine
Huairou Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
Yunling Zhang, Dongfang Hospital
ClinicalTrials.gov Identifier:
NCT01636154
First received: June 29, 2012
Last updated: February 28, 2013
Last verified: February 2013

June 29, 2012
February 28, 2013
January 2012
February 2016   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01636154 on ClinicalTrials.gov Archive Site
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Not Provided
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Clinical Application and Basic Study of Medicinal Fractions-based Herbal Combinations
Clinical Application and Basic Study of Medicinal Fractions-based Herbal Combinations:A Prospective Randomized Controlled Multi-site Clinical Trial About Fractions-based Herbal Combinations of Clearing Heat and Promoting Blood Circulation

The purpose of this study is to investigate the efficacy of fractions-based herbal combinations of clearing heat and promoting blood circulation treating acute ischemic stroke and the potential mechanism of it.

The interaction between fire-heat and blood stasis is a significant mechanism underlying pathogenesis and progress in acute ischemic stroke according to TCM theory.Clinical therapeutic effects are achieved with wide application of Ixeris of sonchifolia Hance components (KDZ injection) representing method of clearing heat and Panax notoginseng saponins components (Xueshuantong injection) representing method of promoting blood circulation.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Ischemic Stroke
  • Drug: Ixeris of sonchifolia Hance
    KDZ40ml+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.
    Other Name: KDZ injection
  • Drug: Panax notoginseng saponins
    Xueshuantong450mg+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.
    Other Name: Xueshuantong injection
  • Drug: Ixeris of sonchifolia Hance combined with Panax notoginseng saponins
    KDZ40ml+0.9%N.S.250ml,ivdrip;0.9%N.S.50ml,ivdrip;Xueshuantong450mg+0.9%N.S.250ml,ivdrip.qd of each 14-day cycle.Number of cycles:one.
  • No Intervention: The basic treatment
    Comply to the Chinese guidelines of acute ischemic stroke in 2010
  • Clearing heat
    Treat with KDZ injection on the basis of the basic treatment
    Intervention: Drug: Ixeris of sonchifolia Hance
  • Promoting blood circulation
    Treat with Xueshuantong injection on the basis of the basic treatment
    Intervention: Drug: Panax notoginseng saponins
  • Experimental: Clearing heat & Promoting blood circulation
    Treat with both KDZ injection and Xueshuantong injection on the basis of the basic treatment
    Intervention: Drug: Ixeris of sonchifolia Hance combined with Panax notoginseng saponins
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
August 2016
February 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with acute ischemic stroke
  • Patients with fire-heat syndrome
  • Stoke onset within 48 hours
  • NIHSS scores range from 5 points to 25 points
  • Age from forty to seventy-five,gender not limited
  • Informed and signed the consent

Exclusion Criteria:

  • Cardiogenic cerebral embolism,stroke caused by other reasons or the unexplained
  • Patients suitable for thrombolytic therapy(rt-PA, urokinase)
  • Patients have received thrombolytic therapy
  • Patients with serious diseases of heart,lungs,liver,kidneys
  • Patients with bleeding or bleeding tendency recently
  • Pregnant or lactating women
  • Pre-existing neurological or psychiatric diseases that could confound the study results
  • Patients be allergic to alcohol,Ixeris of sonchifolia Hance components (KDZ injection) or Panax notoginseng saponins components (Xueshuantong injection)
  • Patients have participated in other clinical trials within 3 months
Both
40 Years to 75 Years
No
Contact: Yunling Zhang, PhD,MD 86 10 67689634
China
 
NCT01636154
BUCMDFH9634
Yes
Yunling Zhang, Dongfang Hospital
Yunling Zhang
  • Shandong University of Traditional Chinese Medicine
  • Huairou Hospital of Traditional Chinese Medicine
Study Chair: Yunling Zhang, PhD,MD Dongfang Hospital,Beijing University of Chinese Medicine
Dongfang Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP