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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02544087
• Other study ID #: 2015DFA31130
• Status: Recruiting
• Phase: N/A
• First received: September 5, 2015
• Last updated: July 27, 2017
• Start date: April 2015
• Est. completion date: April 2018

Study information

• Verified date: July 2017
• Source: Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
• Contact: Zhang, PhD,MD
• Phone: +86 10 67689634
• Email: yunlingzhang2004[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction
• 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;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	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	Department of Neurology,Wuqing Hospital of Traditional Chinese Medicine	Tianjin	Tianjin

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified Rankin scale		180 days
Secondary	Barthel index		180 days
Secondary	national institute of health stroke scale		180 days
Secondary	Glasgow coma scale		180 days
Secondary	scores of Chinese medicine symptoms		180 days
Secondary	mortality rate		180 days
Secondary	disability rate		180 days