Ischemic StrokePhase 3NCT00815763
Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke
A Phase 3 study testing ginsenoside-Rd in people with Ischemic Stroke, run by Xijing Hospital at 1 site in China.
Trial summary
The purpose of this phase 3 study is to validate 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 390 participants
- Where
- 1 siteChina
- Study dates
- Sep 2006to Sep 2008
- Phase
- Phase 3
- 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 3, Multicenter Trial
The purpose of this phase 3 study is to validate the efficacy and safety of ginsenoside-Rd for acute ischemic stroke.
Read the detailed description
A phase Ⅲ randomized, double-blind, placebo-controlled, multicenter study was conducted to examine the efficacy and safety of ginsenoside-Rd in patients with acute ischemic stroke. Stroke patients were randomized equally to receive a 14-day infusion of placebo or ginsenoside-Rd 20mg. Primary end points were NIHSS scores at 15 days. Secondary end points were NIHSS scores and the Barthel index at 8 days, the Barthel index and the modified Rankin scale at 15 days and 90 days. The safety end points included serious and nonserious adverse events, laboratory values and vital signs. Analysis was by intention to treat.
- Conditions
- Ischemic Stroke
- Being tested
- ginsenoside-Rd, placebo
- 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-RdDrug
infusion ginsenoside-Rd 20 mg once a day and continued for 14 day
placeboDrug
infusion placebo once a day and continued for 14 day
| Study group | Role | What they receive |
|---|---|---|
| ginsenoside-Rd 20mg | Experimental | infusion of ginsenoside-Rd 20mg once a day and continued for 14 days Receives: Drug: ginsenoside-Rd |
| placebo | Placebo comparator | infusion placebo (group B)once a day and continued for 14 days Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the modified Rankin scale
Measured: 90 days
Secondary outcomes (5)
NIHSS scores
Measured: 8 days
NIHSS scores
Measured: 15 days
the Barthel index
Measured: 8 days
the Barthel index
Measured: 15 days
the modified Rankin scale
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2008 (estimated)
- Study startSep 2006
- Primary completionJun 2008
- Study completionSep 2008
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 390 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 HospitalXuedong Liu, MD, Study chair, the Department of Neurology, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815763
- Sponsor's protocol ID
- xijing-002
- Status last verified
- Dec 2008
- First submitted
- 29 Dec 2008
- Last updated
- 30 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2008. 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 3, Multicenter Trial
- ClinicalTrials.gov ID
- NCT00815763
- Acronym / sponsor ID
- xijing-002
- Conditions
- Ischemic Stroke
- Keywords
- randomized trial, ischemic stroke, Ginsenoside-Rd
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 30 Dec 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 phase 3 study is to validate the efficacy and safety of ginsenoside-Rd for acute ischemic stroke.
Detailed description
A phase Ⅲ randomized, double-blind, placebo-controlled, multicenter study was conducted to examine the efficacy and safety of ginsenoside-Rd in patients with acute ischemic stroke. Stroke patients were randomized equally to receive a 14-day infusion of placebo or ginsenoside-Rd 20mg. Primary end points were NIHSS scores at 15 days. Secondary end points were NIHSS scores and the Barthel index at 8 days, the Barthel index and the modified Rankin scale at 15 days and 90 days. The safety end points included serious and nonserious adverse events, laboratory values and vital signs. Analysis was by intention to treat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ginsenoside-Rd 20mg | Experimental | Drug: ginsenoside-Rdinfusion of ginsenoside-Rd 20mg once a day and continued for 14 days |
| placebo | Placebo comparator | Drug: placeboinfusion placebo (group B)once a day and continued for 14 days |
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-Rdinfusion ginsenoside-Rd 20 mg once a day and continued for 14 day | Drug | ginsenoside-Rd 20mg |
| placeboinfusion placebo once a day and continued for 14 day | Drug | placebo |
Primary outcome
the modified Rankin scale
Time frame: 90 days
5 secondary outcomes
NIHSS scores
Time frame: 8 days
NIHSS scores
Time frame: 15 days
the Barthel index
Time frame: 8 days
the Barthel index
Time frame: 15 days
the modified Rankin scale
Time frame: 15 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 30 Dec 2008.
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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 3 study testing ginsenoside-Rd 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 30 Dec 2008. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
the modified Rankin scale (time frame: 90 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 30 Dec 2008; AzTrials last refreshed its copy on 7 Nov 2026.