Ischemic StrokeNCT01636154
Clinical Application and Basic Study of Medicinal Fractions-based Herbal Combinations
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 3 sites in China.
Trial summary
The purpose of this study is to investigate the efficacy of fractions-based herbal combinations of clearing heat and promoting blood circulation treating acute ischemic stroke and the potential mechanism of it. Read more about this study
- Who is it for?
- Ages 40 to 75 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
- 3 sitesChina
- Study dates
- Jan 2012to Aug 2016
- 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 75 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
- Stoke onset within 48 hours
- NIHSS scores range from 5 points to 25 points
- Age from forty to seventy-five,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)
- Patients have received thrombolytic therapy
- Patients with serious diseases of heart,lungs,liver,kidneys
- Patients with bleeding or bleeding tendency recently
- Pregnant or lactating women
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- Pre-existing neurological or psychiatric diseases that could confound the study results
- Patients be allergic to alcohol,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
3 sites in 1 country.
China3 sites
Department of Neurology,Dongfang Hospital,Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100078
Department of Neurology,Huairou Hospital of Traditional Chinese Medicine
Beijing, Beijing Municipality, 101400
Department of Neurology,Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, 250011
About this study
Official title: Clinical Application and Basic Study of Medicinal Fractions-based Herbal Combinations:A Prospective Randomized Controlled Multi-site Clinical Trial About Fractions-based Herbal Combinations of Clearing Heat and Promoting Blood Circulation
The purpose of this study is to investigate the efficacy of fractions-based herbal combinations of clearing heat and promoting blood circulation treating acute ischemic stroke and the potential mechanism of it.
Read the detailed description
The interaction between fire-heat and blood stasis is a significant mechanism underlying pathogenesis and progress in acute ischemic stroke according to TCM theory.Clinical therapeutic effects are achieved with wide application of Ixeris of sonchifolia Hance components (KDZ injection) representing method of clearing heat and Panax notoginseng saponins components (Xueshuantong injection) representing method of promoting blood circulation.
- 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, medicinal fractions-based herbal combinations
- 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 injection
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;0.9%N.S.50ml,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 guidelines of acute ischemic stroke in 2010 |
| Clearing heat | Other | Treat with KDZ injection on the basis of the basic treatment Receives: Drug: Ixeris of sonchifolia Hance |
| Promoting blood circulation | Other | Treat with Xueshuantong injection on the basis of the basic treatment Receives: Drug: Panax notoginseng saponins |
| Clearing heat & Promoting blood circulation | Experimental | Treat with both KDZ injection and Xueshuantong injection on the basis of the basic treatment Receives: Drug: Ixeris of sonchifolia Hance combined with Panax notoginseng saponins |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 (actual)
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
- NCT01636154
- Sponsor's protocol ID
- BUCMDFH9634
- Status last verified
- Aug 2016
- First submitted
- 29 Jun 2012
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liu X, Jin X, Chen B, Liu X, Liang X, Fang X, Wu H, Fu X, Zheng H, Ding X, Duan N, Zhang Y. Effects of Kudiezi Injection on Serum Inflammatory Biomarkers in Patients with Acute Cerebral Infarction. Dis Markers. 2018 Sep 2;2018:7936736. doi: 10.1155/2018/7936736. eCollection 2018.
PubMed 30245755
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application and Basic Study of Medicinal Fractions-based Herbal Combinations:A Prospective Randomized Controlled Multi-site Clinical Trial About Fractions-based Herbal Combinations of Clearing Heat and Promoting Blood Circulation
- ClinicalTrials.gov ID
- NCT01636154
- Acronym / sponsor ID
- BUCMDFH9634
- Conditions
- Ischemic Stroke
- Keywords
- fire-heat syndrome, blood stasis syndrome, method of clearing heat, method of promoting blood circulation, medicinal fractions-based herbal combinations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Yunling ZhangUniversity, hospital or other
- Collaborators
- Shandong University of Traditional Chinese Medicine, Huairou Hospital of Traditional Chinese Medicine
- Study start
- Jan 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 10 Jul 2012 (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 investigate the efficacy of fractions-based herbal combinations of clearing heat and promoting blood circulation treating acute ischemic stroke and the potential mechanism of it.
Detailed description
The interaction between fire-heat and blood stasis is a significant mechanism underlying pathogenesis and progress in acute ischemic stroke according to TCM theory.Clinical therapeutic effects are achieved with wide application of Ixeris of sonchifolia Hance components (KDZ injection) representing method of clearing heat and Panax notoginseng saponins components (Xueshuantong injection) representing method of promoting blood circulation.
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 guidelines of acute ischemic stroke in 2010 |
| Clearing heat | Other | Drug: Ixeris of sonchifolia HanceTreat with KDZ injection on the basis of the basic treatment |
| Promoting blood circulation | Other | Drug: Panax notoginseng saponinsTreat with Xueshuantong injection on the basis of the basic treatment |
| Clearing heat & Promoting blood circulation | Experimental | Drug: Ixeris of sonchifolia Hance combined with Panax notoginseng saponinsTreat with both KDZ injection and Xueshuantong injection on the basis of the basic treatment |
Who may qualify
- Ages
- 40 to 75 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
- Stoke onset within 48 hours
- NIHSS scores range from 5 points to 25 points
- Age from forty to seventy-five,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)
- Patients have received thrombolytic therapy
- Patients with serious diseases of heart,lungs,liver,kidneys
- 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 injectionXueshuantong450mg+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one. | Drug | Promoting blood circulation |
| Ixeris of sonchifolia Hance combined with Panax notoginseng saponinsKDZ40ml+0.9%N.S.250ml,ivdrip;0.9%N.S.50ml,ivdrip;Xueshuantong450mg+0.9%N.S.250ml,ivdrip.qd of each 14-day cycle.Number of cycles:one. | Drug | Clearing heat & Promoting blood circulation |
Primary outcome
Not reported in the source record.
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 5 Aug 2016.
- Derived from this study: PubMed 30245755Liu X, Jin X, Chen B, Liu X, Liang X, Fang X, Wu H, Fu X, Zheng H, Ding X, Duan N, Zhang Y. Effects of Kudiezi Injection on Serum Inflammatory Biomarkers in Patients with Acute Cerebral Infarction. Dis Markers. 2018 Sep 2;2018:7936736. doi: 10.1155/2018/7936736. eCollection 2018.
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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
3 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 3 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: finished, as of the sponsor's last update on 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01636154, 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 5 Aug 2016.