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

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ClinicalTrials.gov Identifier: NCT01636154
Recruitment Status : Completed
First Posted : July 10, 2012
Last Update Posted : August 5, 2016
Sponsor:
Collaborators:
Shandong University of Traditional Chinese Medicine
Huairou Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
Yunling Zhang, Dongfang Hospital Beijing University of Chinese Medicine

Tracking Information
First Submitted Date  ICMJE June 29, 2012
First Posted Date  ICMJE July 10, 2012
Last Update Posted Date August 5, 2016
Study Start Date  ICMJE January 2012
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT01636154 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Application and Basic Study of Medicinal Fractions-based Herbal Combinations
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ischemic Stroke
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Liu X, Jin X, Chen B, Liu X, Liang X, Fang X, Wu H, Fu X, Zheng H, Ding X, Duan N, Zhang Y. Effects of Kudiezi Injection on Serum Inflammatory Biomarkers in Patients with Acute Cerebral Infarction. Dis Markers. 2018 Sep 2;2018:7936736. doi: 10.1155/2018/7936736. eCollection 2018.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July¬†5,¬†2012)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01636154
Other Study ID Numbers  ICMJE BUCMDFH9634
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yunling Zhang, Dongfang Hospital Beijing University of Chinese Medicine
Study Sponsor  ICMJE Yunling Zhang
Collaborators  ICMJE
  • Shandong University of Traditional Chinese Medicine
  • Huairou Hospital of Traditional Chinese Medicine
Investigators  ICMJE
Study Chair: Yunling Zhang, PhD,MD Dongfang Hospital Beijing University of Chinese Medicine
PRS Account Dongfang Hospital Beijing University of Chinese Medicine
Verification Date August 2016

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