Ischemic StrokeNCT02544087
Heat-clearing and Blood-activating Chinese Medicinal Components in Acute Cerebral Infarction
A study testing Ixeris of sonchifolia Hance, Panax notoginseng saponins and Ixeris of sonchifolia Hance combined with Panax notoginseng saponins in people with Ischemic Stroke, run by Yunling Zhang at 4 sites in China.
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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Ixeris of sonchifolia Hance, Panax notoginseng saponins and Ixeris of sonchifolia Hance combined with Panax notoginseng saponins
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesChina
- Study dates
- Apr 2015to Apr 2018
- Phase
- Interventional
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Department of Neurology,Dongfang Hospital
Beijing, Beijing Municipality, 100078
Yunling Zhang, PhD,MD, +86 10 67689634, yunlingzhang2004@126.com
- Recruiting
Department of Neurology,Huairou Hospital of Traditional Chinese Medicine
Beijing, Beijing Municipality, 101400
Xiyou Qi, +86 13716441030
- Recruiting
Department of Neurology,Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, 250011
Xianghua Qi, qixianghua2005@163.com
- Recruiting
Department of Neurology,Wuqing Hospital of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 301700
Dan Liu
+86 15122068119
About this study
Official title: Heat-clearing and Blood-activating Chinese Medicinal Components in Acute Cerebral Infarction: Mechanisms of Multi-target Anti-inflammatory Action
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.
Read the detailed 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.
- Conditions
- Ischemic Stroke
- Being tested
- Ixeris of sonchifolia Hance, Panax notoginseng saponins, Ixeris of sonchifolia Hance combined with Panax notoginseng saponins
- Keywords
- fire-heat syndrome, blood stasis syndrome, method of clearing heat, method of promoting blood circulation
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ixeris of sonchifolia HanceDrug
Also called KDZ injection
KDZ40ml+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.
Panax notoginseng saponinsDrug
Also called Xueshuantong injections
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 saponinsDrug
KDZ40ml+0.9%N.S.250ml,ivdrip;Xueshuantong450mg+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.
| Study group | Role | What they receive |
|---|---|---|
| The basic treatment | No intervention | Comply to the Chinese guidlines of acute ischemic stroke in 2014 |
| Clearing heat | Other | Treat with KDZ injection on the basis of basic treatment Receives: Drug: Ixeris of sonchifolia Hance |
| Promoting blood circulaton | Other | Treat with Xueshuantong injection on the basis of basic treatment Receives: Drug: Panax notoginseng saponins |
| Clearing heat&Promoting blood circulaton | Experimental | Treat with both KDZ injection and Xueshuantong injection on the basis of basic treatment Receives: Drug: Ixeris of sonchifolia Hance combined with Panax notoginseng saponins |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin scale
Measured: 180 days
Secondary outcomes (6)
Barthel index
Measured: 180 days
national institute of health stroke scale
Measured: 180 days
Glasgow coma scale
Measured: 180 days
scores of Chinese medicine symptoms
Measured: 180 days
mortality rate
Measured: 180 days
disability rate
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yunling Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong University of Traditional Chinese Medicine, Huairou Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor-investigator, Yunling Zhang, Dongfang Hospital Beijing University of Chinese Medicine
- Investigators
- Yunling Zhang, PhD,MD, Study chair, Dongfang Hospital Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544087
- Sponsor's protocol ID
- 2015DFA31130
- Status last verified
- Jul 2017
- First submitted
- 5 Sep 2015
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heat-clearing and Blood-activating Chinese Medicinal Components in Acute Cerebral Infarction: Mechanisms of Multi-target Anti-inflammatory Action
- ClinicalTrials.gov ID
- NCT02544087
- Acronym / sponsor ID
- 2015DFA31130
- Conditions
- Ischemic Stroke
- Keywords
- fire-heat syndrome, blood stasis syndrome, method of clearing heat, method of promoting blood circulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Yunling ZhangUniversity, hospital or other
- Collaborators
- Shandong University of Traditional Chinese Medicine, Huairou Hospital of Traditional Chinese Medicine
- Study start
- Apr 2015
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 9 Sep 2015 (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 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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| The basic treatment | No intervention | –Comply to the Chinese guidlines of acute ischemic stroke in 2014 |
| Clearing heat | Other | Drug: Ixeris of sonchifolia HanceTreat with KDZ injection on the basis of basic treatment |
| Promoting blood circulaton | Other | Drug: Panax notoginseng saponinsTreat with Xueshuantong injection on the basis of basic treatment |
| Clearing heat&Promoting blood circulaton | Experimental | Drug: Ixeris of sonchifolia Hance combined with Panax notoginseng saponinsTreat with both KDZ injection and Xueshuantong injection on the basis of basic treatment |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Ixeris of sonchifolia HanceAlso: KDZ injectionKDZ40ml+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one. | Drug | Clearing heat |
| Panax notoginseng saponinsAlso: Xueshuantong injectionsXueshuantong450mg+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one. | Drug | Promoting blood circulaton |
| Ixeris of sonchifolia Hance combined with Panax notoginseng saponinsKDZ40ml+0.9%N.S.250ml,ivdrip;Xueshuantong450mg+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one. | Drug | Clearing heat&Promoting blood circulaton |
Primary outcome
modified Rankin scale
Time frame: 180 days
6 secondary outcomes
Barthel index
Time frame: 180 days
national institute of health stroke scale
Time frame: 180 days
Glasgow coma scale
Time frame: 180 days
scores of Chinese medicine symptoms
Time frame: 180 days
mortality rate
Time frame: 180 days
disability rate
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
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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.
Yunling Zhang, PhD,MD study chair
Dongfang Hospital Beijing University of Chinese Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ixeris of sonchifolia Hance, Panax notoginseng saponins and Ixeris of sonchifolia Hance combined with Panax notoginseng saponins in people with Ischemic Stroke, run by Yunling Zhang 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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 31 Jul 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhang, PhD,MD (+86 10 67689634, yunlingzhang2004@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin scale (time frame: 180 days). 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 31 Jul 2017.