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

NCT ID: NCT02176395

Last Updated: 2020-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2020-07-31

Brief Summary

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

Conditions

Acute Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Danhong injection

Based on the standard medical care, 40ml of Danhong injection, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2 hours.

Group Type: EXPERIMENTAL

Danhong injection

Intervention Type: DRUG

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

Standard medical care

Intervention Type: PROCEDURE

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.

placebo

Based on the standard medical care, 40ml of 0.9% saline as the placebo, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2 hours.

Group Type: PLACEBO_COMPARATOR

Standard medical care

Intervention Type: PROCEDURE

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.

placebo

Intervention Type: DRUG

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

healthy volunteer

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

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

Intervention Type: DRUG

Other Intervention Names

A kind of injection made from two kind of Chinese herbs: Salvia miltiorrhiza and Safflower.

Eligibility Criteria

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 Ⅲ 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

China Food and Drug Administration

OTHER_GOV

Sponsor Role: collaborator

China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Zhong Wang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wang Zhong, Professor

Role: PRINCIPAL_INVESTIGATOR

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Zhao Xingquan, Professor

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Wang Yongyan, Professor

Role: STUDY_CHAIR

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Jiang Zhilin, Professor

Role: PRINCIPAL_INVESTIGATOR

202 Military Hospital of China

Locations

Nanshi Hospital of Nanyang

Nanyang, Henan, China

Panjin Central Hospital

Panjin, Liaoning, China

202 Military Hospital of China

Shenyang, Liaoning, China

Affiliated Hospital of Chifeng University

Chifeng, Neimenggu, China

Countries

China

Other Identifiers

DH20140604

Identifier Type: -

Identifier Source: org_study_id