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CompletedNCT01636154Updated Aug 5, 2016

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

An interventional study of Ixeris of sonchifolia Hance and Panax notoginseng saponins in Ischemic Stroke, sponsored by Yunling Zhang. Completed at 3 sites in China. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-08-05.

Sponsored by Yunling Zhang · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ischemic Stroke

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Keywords

  • fire-heat syndrome
  • blood stasis syndrome
  • method of clearing heat
  • method of promoting blood circulation
  • medicinal fractions-based herbal combinations
03

In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 931 are open to participants now.

This study's enrollment of 120 is close to the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Yunling Zhang is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • No intervention
    The basic treatment

    Comply to the Chinese guidelines of acute ischemic stroke in 2010

  • Other
    Clearing heat

    Treat with KDZ injection on the basis of the basic treatment

    Drug: Ixeris of sonchifolia Hance

  • Other
    Promoting blood circulation

    Treat with Xueshuantong injection on the basis of the basic treatment

    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

    Drug: Ixeris of sonchifolia Hance combined with Panax notoginseng saponins

Interventions

  • DrugIxeris of sonchifolia Hance

    KDZ40ml+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.

    Also known as: KDZ injection

  • DrugPanax notoginseng saponins

    Xueshuantong450mg+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.

    Also known as: Xueshuantong injection

  • DrugIxeris 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.

06

Study locations

3 sites
  • Department of Neurology,Dongfang Hospital,Beijing University of Chinese Medicine
    Beijing, Beijing 100078, China
  • Department of Neurology,Huairou Hospital of Traditional Chinese Medicine
    Beijing, Beijing 101400, China
  • Department of Neurology,Affiliated Hospital of Shandong University of Traditional Chinese Medicine
    Jinan, Shandong 250011, China
07

References and documents

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. PubMed 30245755 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01636154
Lead sponsor
Yunling Zhang
Collaborators
Shandong University of Traditional Chinese Medicine, Huairou Hospital of Traditional Chinese Medicine
Responsible party
Yunling Zhang (President of of Dongfang Hospital, Dongfang Hospital Beijing University of Chinese Medicine) — Sponsor-investigator
First posted
Jul 10, 2012
Start date
Jan 2012
Primary completion
Mar 2016
Completion
Aug 2016
Last update
Aug 5, 2016

Study contacts

Yunling Zhang, PhD,MD
study chair · Dongfang Hospital Beijing University of Chinese Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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