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

NCT ID: NCT01636154

Last Updated: 2016-08-05

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

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-08-31

Brief Summary

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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

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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.

Conditions

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Ischemic Stroke

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 guidelines of acute ischemic stroke in 2010

Group Type NO_INTERVENTION

No interventions assigned to this group

Clearing heat

Treat with KDZ injection on the basis of the 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 circulation

Treat with Xueshuantong injection on the basis of the 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 circulation

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

Group Type EXPERIMENTAL

Ixeris of sonchifolia Hance combined with Panax notoginseng saponins

Intervention Type DRUG

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.

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;0.9%N.S.50ml,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 injection

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 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 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 University of Chinese Medicine

Beijing, Beijing Municipality, China

Site Status

Department of Neurology,Huairou Hospital of Traditional Chinese Medicine

Beijing, Beijing Municipality, China

Site Status

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

Jinan, Shandong, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 30245755 (View on PubMed)

Other Identifiers

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BUCMDFH9634

Identifier Type: -

Identifier Source: org_study_id

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