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

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology,Dongfang Hospital,Beijing University of Chinese Medicine, Beijing, Beijing Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ixeris of sonchifolia Hance

Drug

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

Other names: KDZ injection

Panax Notoginseng Saponins

Drug

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

Other names: Xueshuantong injection

Ixeris of sonchifolia Hance combined with Panax notoginseng saponins

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.

Sponsors and collaborators

Lead sponsor

Yunling Zhang

Other

Collaborators

Huairou Hospital of Traditional Chinese Medicine
Shandong University of Traditional Chinese Medicine

Registry information

Official study title

Clinical Application and Basic Study of Medicinal Fractions-based Herbal Combinations:A Prospective Randomized Controlled Multi-site Clinical Trial About Fractions-based Herbal Combinations of Clearing Heat and Promoting Blood Circulation

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: Jul 10, 2012
Registry last updated: Aug 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed