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

NCT ID: NCT02544087

Last Updated: 2017-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2018-04-30

Brief Summary

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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

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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.

Conditions

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Ischemic Stroke

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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The basic treatment

Comply to the Chinese guidlines of acute ischemic stroke in 2014

Group Type NO_INTERVENTION

No interventions assigned to this group

Clearing heat

Treat with KDZ injection on the basis of basic treatment

Group Type OTHER

Ixeris of sonchifolia Hance

Intervention Type DRUG

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

Promoting blood circulaton

Treat with Xueshuantong injection on the basis of basic treatment

Group Type OTHER

Panax notoginseng saponins

Intervention Type DRUG

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

Clearing heat&Promoting blood circulaton

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

Group Type EXPERIMENTAL

Ixeris of sonchifolia Hance combined with Panax notoginseng saponins

Intervention Type DRUG

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

Interventions

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Ixeris of sonchifolia Hance

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

Intervention Type DRUG

Panax notoginseng saponins

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

Intervention Type DRUG

Ixeris 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.

Intervention Type DRUG

Other Intervention Names

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KDZ injection Xueshuantong injections

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Huairou Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Yunling Zhang

OTHER

Sponsor Role lead

Responsible Party

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Yunling Zhang

President of Dongfang Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yunling Zhang, PhD,MD

Role: STUDY_CHAIR

Dongfang Hospital Beijing University of Chinese Medicine

Locations

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Department of Neurology,Dongfang Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Department of Neurology,Huairou Hospital of Traditional Chinese Medicine

Beijing, Beijing Municipality, China

Site Status RECRUITING

Department of Neurology,Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Jinan, Shandong, China

Site Status RECRUITING

Department of Neurology,Wuqing Hospital of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhang, PhD,MD

Role: CONTACT

Phone: +86 10 67689634

Email: [email protected]

Facility Contacts

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Yunling Zhang, PhD,MD

Role: primary

Xiyou Qi

Role: primary

Xianghua Qi

Role: primary

Dan Liu

Role: primary

Role: backup

Other Identifiers

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2015DFA31130

Identifier Type: -

Identifier Source: org_study_id