Ischemic StrokePhase 2NCT00591084
Ginsenoside-Rd for Acute Ischemic Stroke
A Phase 2 study testing ginsenoside-Rd 10 mg and ginsenoside-Rd 20mg in people with Ischemic Stroke, run by Xijing Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of ginsenoside-Rd for acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- ginsenoside-Rd 10 mg and ginsenoside-Rd 20mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 199 participants
- Where
- 1 siteChina
- Study dates
- Sep 2005to Sep 2006
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between 18 to 75 years
- the first episode
- from onset to admission within 72 hours
- NIHSS scores:5~22
Who cannot join
- had other intracranial pathologies (e.g., tumor, infection)
- had a neurologic or psychiatric disease
- had a coexisting condition that limited their life expectancy
- had significant drug or alcohol misuse
- had high-grade carotid artery stenosis for which surgery was planned
- were pregnant or nursing
- participated in a clinical trial with an investigational drug or device within the past 3 months
- were unlikely to be available for follow-up
Trial locations and contacts
1 site in 1 country.
China1 site
the Department of Neurology , Xijing Hospital
Xi'an, Shaanxi, 710032
About this study
Official title: Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke: A Randomized, Double-blind, Placebo-controlled, Phase Ⅱ, Multicenter Trial
The purpose of this study is to evaluate the efficacy and safety of ginsenoside-Rd for acute ischemic stroke.
Read the detailed description
A major contributor to brain injury after stroke is disordered inward flow of Ca2+ and its toxic accumulation in the nervous system following cerebral ischemia. Ginsenoside-Rd, a purified component from total saponins of Panax notoginseng, has a molecular formula of C48H82O18•3H2O with a molecular weight of 1001.2. Ginsenoside-Rd has been shown to inhibit receptor-operated Ca2+ influx through receptor-and-store-operated Ca2+ channels (ROCC) , attenuate oxidative stress in stroke, reduce the size of the cerebral infarction and preserve brain functioning in animal models of acute ischemic stroke.
- Conditions
- Ischemic Stroke
- Being tested
- ginsenoside-Rd 10 mg, placebo, ginsenoside-Rd 20mg
- Keywords
- randomized trial, ischemic stroke, Ginsenoside-Rd
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ginsenoside-Rd 10 mgDrug
infusion ginsenoside-Rd 10 mg (group A)once a day and continued for 14 days
placeboDrug
infusion placebo (group B)once a day and continued for 14 days
ginsenoside-Rd 20mgDrug
infusion of ginsenoside-Rd 20mg (group C) once a day and continued for 14 days
| Study group | Role | What they receive |
|---|---|---|
| ginsenoside-Rd 10mg | Experimental | both a ginsenoside-Rd injection (10mg/1ml/each) and a specific dilution (10%, 1ml trimethylene glycol) were respectively diluted by a specific dilution (10%, 9 ml trimethylene glycol) and then mixed. Receives: Drug: ginsenoside-Rd 10 mg |
| placebo | Placebo comparator | 2 specific dilutions (10%, 1ml trimethylene glycol) were respectively diluted by 2 specific dilutions (10%, 9 ml trimethylene glycol) and then mixed. Receives: Drug: placebo |
| ginsenoside-Rd 20mg | Experimental | 2 ginsenoside-Rd injections (10mg/1ml/each) were respectively diluted by 2 specific dilutions (10%, 9 ml trimethylene glycol) and then mixed Receives: Drug: ginsenoside-Rd 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIHSS scores
Measured: 15±1 days
Secondary outcomes (5)
NIHSS scores
Measured: 8 days
the Barthel index
Measured: 8 days
the Barthel index
Measured: 15 days
the modified Rankin scale
Measured: 15 days
the modified Rankin scale
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startSep 2005
- Primary completionJun 2006
- Study completionSep 2006
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.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Gang Zhao, MD, Study director, the Department of Neurology , Xijing Hospital;Xuedong Liu, MD, Study chair, the Department of Neurology, Xijing Hospital;
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591084
- Sponsor's protocol ID
- xijing-001
- Status last verified
- Dec 2007
- First submitted
- 27 Dec 2007
- Last updated
- 1 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liu X, Xia J, Wang L, Song Y, Yang J, Yan Y, Ren H, Zhao G. Efficacy and safety of ginsenoside-Rd for acute ischaemic stroke: a randomized, double-blind, placebo-controlled, phase II multicenter trial. Eur J Neurol. 2009 May;16(5):569-75. doi: 10.1111/j.1468-1331.2009.02534.x. Epub 2009 Feb 19.
PubMed 19236467
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke: A Randomized, Double-blind, Placebo-controlled, Phase Ⅱ, Multicenter Trial
- ClinicalTrials.gov ID
- NCT00591084
- Acronym / sponsor ID
- xijing-001
- Conditions
- Ischemic Stroke
- Keywords
- randomized trial, ischemic stroke, Ginsenoside-Rd
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 11 Jan 2008 (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 evaluate the efficacy and safety of ginsenoside-Rd for acute ischemic stroke.
Detailed description
A major contributor to brain injury after stroke is disordered inward flow of Ca2+ and its toxic accumulation in the nervous system following cerebral ischemia. Ginsenoside-Rd, a purified component from total saponins of Panax notoginseng, has a molecular formula of C48H82O18•3H2O with a molecular weight of 1001.2. Ginsenoside-Rd has been shown to inhibit receptor-operated Ca2+ influx through receptor-and-store-operated Ca2+ channels (ROCC) , attenuate oxidative stress in stroke, reduce the size of the cerebral infarction and preserve brain functioning in animal models of acute ischemic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ginsenoside-Rd 10mg | Experimental | Drug: ginsenoside-Rd 10 mgboth a ginsenoside-Rd injection (10mg/1ml/each) and a specific dilution (10%, 1ml trimethylene glycol) were respectively diluted by a specific dilution (10%, 9 ml trimethylene glycol) and then mixed. |
| placebo | Placebo comparator | Drug: placebo2 specific dilutions (10%, 1ml trimethylene glycol) were respectively diluted by 2 specific dilutions (10%, 9 ml trimethylene glycol) and then mixed. |
| ginsenoside-Rd 20mg | Experimental | Drug: ginsenoside-Rd 20mg2 ginsenoside-Rd injections (10mg/1ml/each) were respectively diluted by 2 specific dilutions (10%, 9 ml trimethylene glycol) and then mixed |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- between 18 to 75 years
- the first episode
- from onset to admission within 72 hours
- NIHSS scores:5~22
Key exclusion criteria (8 listed)
- had other intracranial pathologies (e.g., tumor, infection)
- had a neurologic or psychiatric disease
- had a coexisting condition that limited their life expectancy
- had significant drug or alcohol misuse
- had high-grade carotid artery stenosis for which surgery was planned
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 |
|---|---|---|
| ginsenoside-Rd 10 mginfusion ginsenoside-Rd 10 mg (group A)once a day and continued for 14 days | Drug | ginsenoside-Rd 10mg |
| placeboinfusion placebo (group B)once a day and continued for 14 days | Drug | placebo |
| ginsenoside-Rd 20mginfusion of ginsenoside-Rd 20mg (group C) once a day and continued for 14 days | Drug | ginsenoside-Rd 20mg |
Primary outcome
NIHSS scores
Time frame: 15±1 days
5 secondary outcomes
NIHSS scores
Time frame: 8 days
the Barthel index
Time frame: 8 days
the Barthel index
Time frame: 15 days
the modified Rankin scale
Time frame: 15 days
the modified Rankin scale
Time frame: 90 days
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 1 Sep 2010.
- Derived from this study: PubMed 19236467Liu X, Xia J, Wang L, Song Y, Yang J, Yan Y, Ren H, Zhao G. Efficacy and safety of ginsenoside-Rd for acute ischaemic stroke: a randomized, double-blind, placebo-controlled, phase II multicenter trial. Eur J Neurol. 2009 May;16(5):569-75. doi: 10.1111/j.1468-1331.2009.02534.x. Epub 2009 Feb 19.
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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.
Gang Zhao, MD study director
the Department of Neurology , Xijing Hospital;
Xuedong Liu, MD study chair
the Department of Neurology, Xijing Hospital;
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ginsenoside-Rd 10 mg and ginsenoside-Rd 20mg in people with Ischemic Stroke, run by Xijing Hospital at 1 site 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 4 inclusion and 8 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 1 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
NIHSS scores (time frame: 15±1 days). 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 NCT00591084, 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 1 Sep 2010.