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

Primary Purpose

Ischemic Stroke

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ixeris of sonchifolia Hance
Panax notoginseng saponins
Ixeris of sonchifolia Hance combined with Panax notoginseng saponins
Sponsored by
Yunling Zhang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring fire-heat syndrome, blood stasis syndrome, method of clearing heat, method of promoting blood circulation

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

  • Department of Neurology,Dongfang HospitalRecruiting
  • Department of Neurology,Huairou Hospital of Traditional Chinese MedicineRecruiting
  • Department of Neurology,Affiliated Hospital of Shandong University of Traditional Chinese MedicineRecruiting
  • Department of Neurology,Wuqing Hospital of Traditional Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Other

Other

Experimental

Arm Label

The basic treatment

Clearing heat

Promoting blood circulaton

Clearing heat&Promoting blood circulaton

Arm Description

Comply to the Chinese guidlines of acute ischemic stroke in 2014

Treat with KDZ injection on the basis of basic treatment

Treat with Xueshuantong injection on the basis of basic treatment

Treat with both KDZ injection and Xueshuantong injection on the basis of basic treatment

Outcomes

Primary Outcome Measures

modified Rankin scale

Secondary Outcome Measures

Barthel index
national institute of health stroke scale
Glasgow coma scale
scores of Chinese medicine symptoms
mortality rate
disability rate

Full Information

First Posted
September 5, 2015
Last Updated
July 27, 2017
Sponsor
Yunling Zhang
Collaborators
Shandong University of Traditional Chinese Medicine, Huairou Hospital of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02544087
Brief Title
Heat-clearing and Blood-activating Chinese Medicinal Components in Acute Cerebral Infarction
Official Title
Heat-clearing and Blood-activating Chinese Medicinal Components in Acute Cerebral Infarction: Mechanisms of Multi-target Anti-inflammatory Action
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yunling Zhang
Collaborators
Shandong University of Traditional Chinese Medicine, Huairou Hospital of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
fire-heat syndrome, blood stasis syndrome, method of clearing heat, method of promoting blood circulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The basic treatment
Arm Type
No Intervention
Arm Description
Comply to the Chinese guidlines of acute ischemic stroke in 2014
Arm Title
Clearing heat
Arm Type
Other
Arm Description
Treat with KDZ injection on the basis of basic treatment
Arm Title
Promoting blood circulaton
Arm Type
Other
Arm Description
Treat with Xueshuantong injection on the basis of basic treatment
Arm Title
Clearing heat&Promoting blood circulaton
Arm Type
Experimental
Arm Description
Treat with both KDZ injection and Xueshuantong injection on the basis of basic treatment
Intervention Type
Drug
Intervention Name(s)
Ixeris of sonchifolia Hance
Other Intervention Name(s)
KDZ injection
Intervention Description
KDZ40ml+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.
Intervention Type
Drug
Intervention Name(s)
Panax notoginseng saponins
Other Intervention Name(s)
Xueshuantong injections
Intervention Description
Xueshuantong450mg+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.
Intervention Type
Drug
Intervention Name(s)
Ixeris of sonchifolia Hance combined with Panax notoginseng saponins
Intervention Description
KDZ40ml+0.9%N.S.250ml,ivdrip;Xueshuantong450mg+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.
Primary Outcome Measure Information:
Title
modified Rankin scale
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Barthel index
Time Frame
180 days
Title
national institute of health stroke scale
Time Frame
180 days
Title
Glasgow coma scale
Time Frame
180 days
Title
scores of Chinese medicine symptoms
Time Frame
180 days
Title
mortality rate
Time Frame
180 days
Title
disability rate
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhang, PhD,MD
Phone
+86 10 67689634
Email
yunlingzhang2004@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunling Zhang, PhD,MD
Organizational Affiliation
Dongfang Hospital Beijing University of Chinese Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Neurology,Dongfang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100078
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunling Zhang, PhD,MD
Phone
+86 10 67689634
Email
yunlingzhang2004@126.com
Facility Name
Department of Neurology,Huairou Hospital of Traditional Chinese Medicine
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101400
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiyou Qi
Phone
+86 13716441030
Facility Name
Department of Neurology,Affiliated Hospital of Shandong University of Traditional Chinese Medicine
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianghua Qi
Email
qixianghua2005@163.com
Facility Name
Department of Neurology,Wuqing Hospital of Traditional Chinese Medicine
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
301700
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Liu
Phone
+86 15122068119

12. IPD Sharing Statement

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

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