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

Heat-clearing and Blood-activating Chinese Medicinal Components in Acute Cerebral Infarction: Mechanisms of Multi-target Anti-inflammatory Action

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.

Study Overview

• Status: Unknown
• Conditions: Ischemic Stroke
• Intervention / Treatment: Drug: Ixeris of sonchifolia Hance; Drug: Panax notoginseng saponins; Drug: Ixeris of sonchifolia Hance combined with Panax notoginseng saponins

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100078
      • Recruiting
      • Department of Neurology,Dongfang Hospital
    • Beijing, Beijing, China, 101400
      • Recruiting
      • Department of Neurology,Huairou Hospital of Traditional Chinese Medicine
      • Contact: Xiyou Qi; Phone Number: +86 13716441030
  • Shandong
    • Jinan, Shandong, China, 250011
      • Recruiting
      • Department of Neurology,Affiliated Hospital of Shandong University of Traditional Chinese Medicine
      • Contact: Xianghua Qi; Email: qixianghua2005@163.com
  • Tianjin
    • Tianjin, Tianjin, China, 301700
      • Recruiting
      • Department of Neurology,Wuqing Hospital of Traditional Chinese Medicine
      • Contact: Dan Liu
      • Contact: Phone Number: +86 15122068119

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: The basic treatment; Comply to the Chinese guidlines of acute ischemic stroke in 2014
Other: Clearing heat; Treat with KDZ injection on the basis of basic treatment	Drug: Ixeris of sonchifolia Hance; KDZ40ml+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.; Other Names: KDZ injection
Other: Promoting blood circulaton; Treat with Xueshuantong injection on the basis of basic treatment	Drug: Panax notoginseng saponins; Xueshuantong450mg+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.; Other Names: Xueshuantong injections
Experimental: Clearing heat&Promoting blood circulaton; Treat with both KDZ injection and Xueshuantong injection on the basis of basic treatment	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
modified Rankin scale	180 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Barthel index	180 days
national institute of health stroke scale	180 days
Glasgow coma scale	180 days
scores of Chinese medicine symptoms	180 days
mortality rate	180 days
disability rate	180 days

Collaborators and Investigators

• Sponsor: Yunling Zhang
• Collaborators: Shandong University of Traditional Chinese Medicine; Huairou Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: September 5, 2015
• First Submitted That Met QC Criteria: September 5, 2015
• First Posted (Estimate): September 9, 2015

Study Record Updates

• Last Update Posted (Actual): July 31, 2017
• Last Update Submitted That Met QC Criteria: July 27, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: fire-heat syndrome; blood stasis syndrome; method of clearing heat; method of promoting blood circulation
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Brain Infarction; Infarction; Ischemic Stroke; Cerebral Infarction
• Other Study ID Numbers: 2015DFA31130