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Status unknownNCT02544087Updated Jul 31, 2017

Heat-clearing and Blood-activating Chinese Medicinal Components in Acute Cerebral Infarction

An interventional study of Ixeris of sonchifolia Hance and Panax notoginseng saponins in Ischemic Stroke, sponsored by Yunling Zhang. Status unknown at 4 sites in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-07-31.

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

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study summary

The present study is designed to confirm the therapeutic effects of heat-clearing and blood-activating Chinese medicinal components in treatment of Acute Cerebral Infarction (ACI) and to investigate the therapeutic mechanisms of multi-target anti-inflammatory action involved from the standpoint of pathology, cell and molecular biology, as well as immunology.

Read the detailed description

The present study is designed to confirm the therapeutic effects of heat-clearing and blood-activating Chinese medicinal components in treatment of Acute Cerebral Infarction (ACI) and to investigate the therapeutic mechanisms of multi-target anti-inflammatory action involved from the standpoint of pathology, cell and molecular biology, as well as immunology. In particular, investigators choose heat-clearing Ixeris of sonchifolia Hance(Kudiezi Injection) and blood-activating Panax notoginseng saponins(Xueshuantong Injection)as the therapeutic interventions to carry out the investigation, applying the key techniques such as Lentivirus-mediated RNA interference, co-immunoprecipitation and immunomagnetic beads.

With the joint efforts, investigators hope to find out the combined therapeutic targets based on better understanding of the inflammatory pathology in ACI and illuminate the synergistic mechanisms involved, which may validate the Chinese medicine theory of"cerebral vascular damage due to heat toxicity" in the pathogenesis of ACI and yield new therapeutic strategies for ACI. As an international science and technology cooperation project, the study is of great significance in establishing an international technology platform of intervention target system for the treatment of ACI; moreover, it marks a key step forward for China to enhance China's international brands through exploring a successful mode of foreign cooperation in Chinese medicine.

02

Conditions studied

  • Ischemic Stroke

Keywords

  • fire-heat syndrome
  • blood stasis syndrome
  • method of clearing heat
  • method of promoting blood circulation
03

In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.

This study's planned 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 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with acute ischemic stroke
  • Patients with fire-heat syndrome
  • Stroke onset within 48 hours
  • NIHSS scores range from 5 points to 25 points
  • Age from forty to eighty,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),or have recieved thrombolytic therapy
  • Patients suitable for endovascular therapy,or have recieved endovascular therapy
  • Patients with serious disease of heart,lungs,liver or kidneys(The value of ALT or AST is more than 2 times of the upper limit of normal range,the value of creatinine is more than 1.5 times of the upper limit of normal range,asthma or COPD,or cardiac function level 4)
  • Patients with bleeding or bleeding tendency recently
  • Pregnant or lactating women
  • Pre-existing limb dysfunction, psychiatric diaseses,or cognitive dysfunction that could confound the study results
  • Patients with allergic constitutions,or have the contraindication of 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 (estimated)

Study arms

  • No intervention
    The basic treatment

    Comply to the Chinese guidlines of acute ischemic stroke in 2014

  • Other
    Clearing heat

    Treat with KDZ injection on the basis of basic treatment

    Drug: Ixeris of sonchifolia Hance

  • Other
    Promoting blood circulaton

    Treat with Xueshuantong injection on the basis of basic treatment

    Drug: Panax notoginseng saponins

  • Experimental
    Clearing heat&Promoting blood circulaton

    Treat with both KDZ injection and Xueshuantong injection on the basis of 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 injections

  • DrugIxeris of sonchifolia Hance combined with Panax notoginseng saponins

    KDZ40ml+0.9%N.S.250ml,ivdrip;Xueshuantong450mg+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.

06

What researchers measure

Primary outcomes

  1. modified Rankin scale

    Time frame: 180 days

Secondary outcomes

  1. Barthel index

    Time frame: 180 days

  2. national institute of health stroke scale

    Time frame: 180 days

  3. Glasgow coma scale

    Time frame: 180 days

  4. scores of Chinese medicine symptoms

    Time frame: 180 days

  5. mortality rate

    Time frame: 180 days

  6. disability rate

    Time frame: 180 days

07

Study locations

4 of 4 sites recruiting
  • Department of Neurology,Dongfang Hospital
    Beijing, Beijing 100078, China
    Recruiting
  • Department of Neurology,Huairou Hospital of Traditional Chinese Medicine
    Beijing, Beijing 101400, China
    • Xiyou Qi · Contact · +86 13716441030
    Recruiting
  • Department of Neurology,Affiliated Hospital of Shandong University of Traditional Chinese Medicine
    Jinan, Shandong 250011, China
    Recruiting
  • Department of Neurology,Wuqing Hospital of Traditional Chinese Medicine
    Tianjin, Tianjin 301700, China
    • Dan Liu · Contact
    • · Contact · +86 15122068119
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02544087
Lead sponsor
Yunling Zhang
Collaborators
Shandong University of Traditional Chinese Medicine, Huairou Hospital of Traditional Chinese Medicine
Responsible party
Yunling Zhang (President of Dongfang Hospital, Dongfang Hospital Beijing University of Chinese Medicine) — Sponsor-investigator
First posted
Sep 9, 2015
Start date
Apr 2015
Primary completion
Apr 2018 (estimated)
Completion
Apr 2018 (estimated)
Last update
Jul 31, 2017

Study contacts

Zhang, PhD,MD
Contact
yunlingzhang2004@126.com
+86 10 67689634
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 status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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