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

Not Applicable

Completed

• Conditions: Ischemic Stroke
• Interventions: Drug: Ixeris of sonchifolia Hance; Drug: Ixeris of sonchifolia Hance combined with Panax notoginseng saponins; Drug: Panax notoginseng saponins

• Registration Number: NCT01636154
• Lead Sponsor: Yunling Zhang

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-06-29
• Study First Submitted QC: 2012-07-05
• Study First Posted: 2012-07-10
• Primary Completion: 2016-03
• Status Verified: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2016-08-04
• Last Update Posted: 2016-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Clearing heat	Ixeris of sonchifolia Hance	Treat with KDZ injection on the basis of the basic treatment
Clearing heat & Promoting blood circulation	Ixeris of sonchifolia Hance combined with Panax notoginseng saponins	Treat with both KDZ injection and Xueshuantong injection on the basis of the basic treatment
Promoting blood circulation	Panax notoginseng saponins	Treat with Xueshuantong injection on the basis of the basic treatment

Trial Locations

Locations (3)

Department of Neurology,Dongfang Hospital,Beijing University of Chinese Medicine; 🇨🇳 Beijing, Beijing, China

Department of Neurology,Huairou Hospital of Traditional Chinese Medicine; 🇨🇳 Beijing, Beijing, China

Department of Neurology,Affiliated Hospital of Shandong University of Traditional Chinese Medicine; 🇨🇳 Jinan, Shandong, China