Multi-"Omics" Research of Danhong Injection to Treat Acute Ischemic Stroke

Acute Stroke Clinical Trial

Official title:

Multi-"Omics" Research of Danhong Injection to Treat Acute Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02176395
• Other study ID #: DH20140604
• Status: Completed
• Phase: Phase 4
• Start date: June 2014
• Est. completion date: July 2020

Study information

• Verified date: July 2020
• Source: China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to explore the pharmacological mechanism of Danhong injection in the treatment of acute ischemic stroke.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 2020
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Female or male inpatients

• Age: 18 - 70 years.

• Clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition and/or gaze, vision or neglect. Ischemic stroke is defined as an event characterized by the sudden onset of an acute focal neurologic deficit presumed to be due to cerebral ischemia after CT scan excludes hemorrhage.

• Clinical diagnosis of "Xueyu Zheng" (Blood Stasis Syndrome) as the scores of Chinese medicine symptoms scales of "Xueyu Zheng" in ischemic stroke = 20. The Chinese medicine symptoms scales of "Xueyu Zheng" is defined as following (1)hemiplegia-10,(2)numbness of limbs-10,(3) dark face-9,(4)purple or dark lip-8,(5)Roughness of skin-4, (6) pain with fixed point-5, (7) purple or dark tongue-10,(8)ecchymosis on tongue-10,(9)purple sublingual vessel-10,(10)varicose sublingual vessel-8,(11)unsmooth pulse-8,(12)intermittent pulse-1.

• Onset of symptoms in 1 week prior to initiation of administration of study drug.

• Clinical diagnosis of cerebral anterior circulation obstruction.

• 4=NIHSS<20.

• Patient is willing to participate voluntarily and to sign a written patient informed consent. Informed consent will be obtained from each patient or the subject's legally authorized representative or relatives, or deferred where applicable, according to the regulatory and legal requirements of the participating centers.

2. Female or male healthy volunteer

• Age: 18 - 70 years.

• Medical history, physical examination, vital signs, electrocardiogram(ECG) and laboratory results (including renal function, hepatic function, et al)with no clinically significant findings.

• Healthy volunteer is willing to participate voluntarily and to sign a written informed consent form. Informed consent will be obtained from each volunteer, according to the regulatory and legal requirements of the participating centers.

Exclusion Criteria:

1. Female or male inpatients

• Evidence of intracranial hemorrhage (ICH) or other cerebral diseases (eg.vascular malformation, tumor, abscess or multiple sclerosis etc.)on the CT-or MRI-scan.

• Patients with thrombolysis or endovascular treatment.

• Known history of allergy or suspected allergic to the drug.

• Blood glucose 2.8 or > 16.8 mmol / l under the treatment of diabetes or with severe complications due to diabetes (eg. peripheral neuropathy, diabetic gangrene).

• Liver function impairment with the value of ALT or AST over 1.5-fold of normal value.

• Renal dysfunction with the value of serum creatinine over 1.5-fold of normal value.

• Severe cardiac dysfunction on echocardiogram or the grade of heart function over ? grade.

• History of prior stroke with mRS =2.

• Complicated with atrial fibrillation.

• Severe stroke as assessed by appropriate imaging techniques (eg. massive cerebral infarction including more than one lobe of brain or over 1/3 of blood-supply area of middle cerebral artery).

• Prior disable patients.

• Hemorrhagic tendency or recent severe or dangerous bleeding in 3 months.

• Suspected addicted into alcohol or drug abuse.

• With severe complications that would make the condition more complicated assessed by the investigator.

• Woman with pregnancy, lactation or positive result of pregnancy test, or women who want to be pregnant in recent 6 months.

• Woman who is under menstrual period.

• Patient who is participating in other trials or has been participated in other trials in recent 3 months.

2. Healthy volunteer

• Had a known history of chronic diseases including stroke, heart diseases, diabetes, COPD, Neuropsychiatric diseases and chronic infectious diseases, etc.

• Coagulation disorders.

• Conditions with increased bleeding risk.

• Trauma or surgery in the 6 months prior to the study.

• Use of any medication 4 weeks prior to the trial.

• History of drug abuse.

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

Drug:
• Danhong injection
40ml Danhong injection added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion

Procedure:
• Standard medical care
Standard medical care is in accordance with China Guideline for the diagnosis and treatment of acute ischemic stroke (2010), including medical care for vital signs, control of temperature, blood pressure and glucose, improving cerebral blood circulation, antiplatelet treatment and nutritional supportive care.

Drug:
• placebo
0.9% saline added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion

Locations

Country	Name	City	State
China	Affiliated Hospital of Chifeng University	Chifeng	Neimenggu
China	Nanshi Hospital of Nanyang	Nanyang	Henan
China	Panjin Central Hospital	Panjin	Liaoning
China	202 Military Hospital of China	Shenyang	Liaoning

Sponsors (2)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences	China Food and Drug Administration

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The changes of serum proteomics in 36 patients selected from certain center	We wish to identify protein biomarkers in the blood that changed with Danhong treatment	Day 0, Day 14, Day 90
Other	The microRNA profile in 10 healthy volunteer		Day0
Other	The mRNA profiles in 10 healthy volunteer		Day0
Other	The proteomics profiles of 10 healthy volunteer		Day 0
Primary	Modified Rankin Scale 0-1 (favourable outcome) at Day 90		Day 90