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Acute StrokePhase 4NCT01677208

Danhong Injection in the Treatment of 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 62 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether Danhong injection is effective in the treatment of acute ischemic stroke. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Acute Stroke
What is being tested?
Danhong injection and Standard medical care
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,503 participants
Where
62 sitesChina
Study dates
13 Mar 2013to 27 Mar 2019
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
  • No healthy volunteers
  • 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.
  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

62 sites in 1 country.

62 sites in 1 country

China62 sites

  • Anshan Central Hospital

    Anshan, Liaoning, 114001

  • The Second Central Hospital of Baoding City

    Baoding, Hebei, 072750

  • The Second Artillery General Hospital of Chinese People's Liberation Army

    Beijing, Beijing Municipality, 100088

  • Peking University First Hospital

    Beijing, 100034

  • Tiantan Hospital Affiliated to Capital Medical University

    Beijing, 100050

  • Xuan Wu Hospital Affiliated to Capital Medical University

    Beijing, 100053

  • Jilin Province People's Hospital

    Changchun, Jilin, 130021

  • The Affiliated Hopital to Changchun University of Chinese Medicine

    Changchun, Jilin, 130021

  • The First Hospital Affiliated to Jilin University

    Changchun, Jilin, 130021

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin, 130033

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130041

  • Changsha Central Hospital

    Changsha, Hunan, 410004

  • The First Hospital of Changsha

    Changsha, Hunan, 410005

  • The second people's hospital of Hunan Province

    Changsha, Hunan, 410007

  • Xiangya Hospital Central-south University

    Changsha, Hunan, 410008

  • Affiliated Hospital of Chengde Medical University

    Chengde, Hebei, 067000

  • Teaching Hospital of Chengdu University of Traditional Chinese Medicine

    Chengdu, Sichuan, 610072

  • The First Affiliated Hopital of Chengdu Medical College

    Chengdu, Sichuan, 610500

  • Affiliated Hospital of Chifeng University

    Chifeng, Neimenggu, 024005

  • Xinqiao Hospital of Third Military Medical University

    Chongqing, Chongqing Municipality, 400037

  • Chongqing Three Gorges Central Hospital

    Chongqing, Chongqing Municipality, 404000

  • Affiliated Zhongshan Hospital of Dalian University

    Dalian, Liaoning, 116001

  • Dandong First Hospital

    Dandong, Liaoning, 118015

  • Guangdong No.2 Provincial People's Hospital

    Guangzhou, Guangdong, 510317

  • Guangzhou hospital of integrated Chinese and Western medicine

    Guangzhou, Guangdong, 510813

  • Handan Central Hospital

    Handan, Hebei, 056001

  • Xin Hua Hospital of Zhejiang Province

    Hangzhou, Zhejiang, 310005

  • Zhejiang Provincial Hospital of T.C.M.

    Hangzhou, Zhejiang, 310006

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014

  • The Second Affiliated Hopital of Harbin Medical University

    Harbin, Helongjiang, 150001

  • Huzhou Central Hospital

    Huzhou, Zhejiang, 313003

  • Liaoyuan Traditional Chinese Medical Hospital

    Liaoyuan, Jilin, 136299

  • Fenyang Hospital of Shanxi Province

    Lüliang, Shanxi, 032299

  • The Second Chinese Medical Hospital of Luoyang City

    Luoyang, Henan, 471003

  • Nanjing Hospital of T.C.M.

    Nanjing, Jiangsu, 210001

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210003

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

  • Nanyang T.C.M. Hospital

    Nanyang, Henan, 473007

  • Nanshi Hospital of Nanyang

    Nanyang, Henan, 473065

  • Panjin Central Hospital

    Panjin, Liaoning, 124013

  • People's Liberation Army No.202 Hospital

    Shenyang, Liaoning, 110003

  • The General Hospital of Shenyang Military

    Shenyang, Liaoning, 110016

  • People's Liberation Army No.463 Hospital

    Shenyang, Liaoning, 110046

  • The Second People's Hospital of Shenzhen

    Shenzhen, Guangdong, 518028

  • The Second Affiliated Hospital to Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

    Tianjin, Tianjin Municipality, 300193

  • The Central Hospital of Wuhan

    Wuhan, Hubei, 430014

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430030

  • Zhongshan Hospital of Hubei Province

    Wuhan, Hubei, 430033

  • Fifth Hospital in Wuhan

    Wuhan, Hubei, 430050

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

  • Tianyou Hospital Affiliated to Wuhan University of Science & Technology

    Wuhan, Hubei, 430064

  • Huangpi District Hospital of T.C.M.

    Wuhan, Hubei, 430399

  • Shanxi Province Hospital of T.C.M.

    Xi’an, Shanxi, 710003

  • The PLA Fourth Fifty-one Hospital

    Xi’an, Shanxi, 710054

  • Shanxi Provincial People's Hospital

    Xi’an, Shanxi, 710068

  • Affiliated Hospital of Shanxi University of Chinese Medicine

    Xianyang, Shanxi, 712000

  • The Second Affiliated Hospital of Shanxi University of T.C.M.

    Xianyang, Shanxi, 712000

  • The First Affiliated Hospital of Henan University of T.C.M.

    Zhengzhou, Henan, 450000

  • People's Hospital of Zhengzhou

    Zhengzhou, Henan, 450003

  • Zhengzhou NO.7 People's Hospital

    Zhengzhou, Henan, 450006

  • Zhoukou Hospital of T.C.M.

    Zhoukou, Henan, 466099

Other trials in China

About this study

Official title: A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Danhong Injection in the Treatment of Acute Ischemic Stroke

The purpose of this study is to determine whether Danhong injection is effective 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
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

    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 groups in NCT01677208
Study groupRoleWhat they receive
Danhong injectionExperimentalBased 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
placeboPlacebo comparatorBased 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modified Rankin Scale 0-1 (favourable outcome) at Day 90

    Measured: Day 90

Secondary outcomes (10)

  1. The Score of effect on symptoms of "Xueyue Zheng"(Blood Stasis syndrome)

    Measured: Day 0, Day7, Day 14, Day 30, Day 60, Day 90

  2. Barthel Index score ≥90

    Measured: Day 0, Day7, Day 14, Day 30, Day 60, Day 90

  3. NIH stroke scale(NIHSS)

    The improvement of the NIHSS score ≥4 or the NIHSS score of 0 to 1

    Measured: Day 0, Day7, Day 14, Day 30, Day 60, Day 90

  4. EQ-5D scale

    Measured: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90

  5. Global disability on mRS at Day 90.

    The proportion of patients with mRS ≥3 at Day 90.

    Measured: Day 90

  6. Incidence of new-onset major vascular events in 90 days

    Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death.

    Measured: Day 90

  7. Overall mortality at day 90

    Measured: Day 90

  8. Incidence of severe hemorrhages in 90 days

    The definition of "Severe hemorrhages" is in accordance with the GUSTO bleeding criteria, including fatal intracranial hemorrhage (ICH), symptomatic intracerebral hemorrhage (sICH) or which could result in substantial hemodynamic compromise requiring treatment.

    Measured: Day 90

  9. Incidence of moderate hemorrhages in 90 days

    The definition of "moderate hemorrhages" is in accordance with the GUSTO bleeding criteria, which requires blood transfusion but not results in hemodynamic compromise.

    Measured: Day 90

  10. Documentation of adverse events (AEs) and serious AEs

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2012 (estimated)
  2. Study start13 Mar 2013
  3. Primary completion10 Mar 2019
  4. Study completion27 Mar 2019

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,503 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01677208
Sponsor's protocol ID
DH20120423
Status last verified
Jun 2022
First submitted
29 Aug 2012
Last updated
8 Jun 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Li B, Wang Y, Lu J, Liu J, Yuan Y, Yu Y, Wang P, Zhao X, Wang Z. Evaluating the effects of Danhong injection in treatment of acute ischemic stroke: study protocol for a multicenter randomized controlled trial. Trials. 2015 Dec 9;16:561. doi: 10.1186/s13063-015-1076-4.

    PubMed 26654631

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 62 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 8 inclusion and 17 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 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 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?

On the ClinicalTrials.gov record for NCT01677208, which also lists 1 linked publication.

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 8 Jun 2022.

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