Acute StrokePhase 4NCT02176395
Multi-"Omics" Research of Danhong Injection to Treat Acute Ischemic Stroke
A Phase 4 study testing Danhong injection and Standard medical care in people with Acute Stroke, run by China Academy of Chinese Medical Sciences at 4 sites in China.
Trial summary
The purpose of this study is to explore the pharmacological mechanism of Danhong injection in the treatment of acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Danhong injection and Standard medical care
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 4 sitesChina
- Study dates
- Jun 2014to Jul 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- 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.
Who cannot join
- 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.
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- 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.
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Affiliated Hospital of Chifeng University
Chifeng, Neimenggu, 024005
Nanshi Hospital of Nanyang
Nanyang, Henan, 473065
Panjin Central Hospital
Panjin, Liaoning, 124013
202 Military Hospital of China
Shenyang, Liaoning
About this study
The purpose of this study is to explore the pharmacological mechanism of Danhong injection in the treatment of acute ischemic stroke.
- Conditions
- Acute Stroke
- Being tested
- Danhong injection, Standard medical care, placebo
- Keywords
- Acute Ischemic Stroke, Randomized Controlled Trial, Traditional Chinese Medicine, Proteomics
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Danhong injectionDrug
Also called A kind of injection made from two kind of Chinese herbs: Salvia miltiorrhiza and Safflower.
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 careProcedure or surgery
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.
placeboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Danhong injection | Experimental | 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. Receives: Drug: Danhong injection; Procedure: Standard medical care |
| placebo | Placebo comparator | 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. Receives: Procedure: Standard medical care; Drug: placebo |
| healthy volunteer | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale 0-1 (favourable outcome) at Day 90
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2019
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- China Food and Drug Administration
- Responsible party
- Principal investigator, Zhong Wang, China Academy of Chinese Medical Sciences
- Investigators
- Wang Zhong, Professor, Principal investigator, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical SciencesZhao Xingquan, Professor, Principal investigator, Beijing Tiantan HospitalWang Yongyan, Professor, Study chair, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical SciencesJiang Zhilin, Professor, Principal investigator, 202 Military Hospital of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176395
- Sponsor's protocol ID
- DH20140604
- Status last verified
- Jul 2020
- First submitted
- 20 Jun 2014
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-"Omics" Research of Danhong Injection to Treat Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02176395
- Acronym / sponsor ID
- DH20140604
- Conditions
- Acute Stroke
- Keywords
- Acute Ischemic Stroke, Randomized Controlled Trial, Traditional Chinese Medicine, Proteomics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- China Food and Drug Administration
- Study start
- Jun 2014
- Primary completion
- Mar 2019 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 27 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore the pharmacological mechanism of Danhong injection in the treatment of acute ischemic stroke.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Danhong injection | Experimental | Drug: Danhong injection, Procedure: Standard medical careBased 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. |
| placebo | Placebo comparator | Procedure: Standard medical care, Drug: placeboBased 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. |
| healthy volunteer | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Female or male inpatients
- Female or male healthy volunteer
Key exclusion criteria (25 listed)
- Female or male inpatients
- Healthy volunteer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Danhong injectionAlso: A kind of injection made from two kind of Chinese herbs: Salvia miltiorrhiza and Safflower.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 | Drug | Danhong injection |
| Standard medical careStandard 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. | Procedure or surgery | Danhong injection, placebo |
| placebo0.9% 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 | Drug | placebo |
Primary outcome
Modified Rankin Scale 0-1 (favourable outcome) at Day 90
Time frame: Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wang Zhong, Professor principal investigator
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Zhao Xingquan, Professor principal investigator
Beijing Tiantan Hospital
Wang Yongyan, Professor study chair
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Danhong injection and Standard medical care in people with Acute Stroke, run by China Academy of Chinese Medical Sciences at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale 0-1 (favourable outcome) at Day 90 (time frame: Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.