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

Ischemic Stroke Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01636154
• Other study ID #: BUCMDFH9634
• Status: Completed
• Phase: N/A
• First received: June 29, 2012
• Last updated: August 4, 2016
• Start date: January 2012
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemic Stroke

Intervention

Drug:
• Ixeris of sonchifolia Hance
KDZ40ml+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.
• Panax notoginseng saponins
Xueshuantong450mg+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.
• 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.

Locations

Country	Name	City	State
China	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

Sponsors (3)

Lead Sponsor	Collaborator
Yunling Zhang	Huairou Hospital of Traditional Chinese Medicine, Shandong University of Traditional Chinese Medicine

Country where clinical trial is conducted

China,