Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
199 participants
INTERVENTIONAL
2005-09-30
2006-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ginsenoside-Rd 10mg
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.
ginsenoside-Rd 10 mg
infusion ginsenoside-Rd 10 mg (group A)once a day and continued for 14 days
placebo
2 specific dilutions (10%, 1ml trimethylene glycol) were respectively diluted by 2 specific dilutions (10%, 9 ml trimethylene glycol) and then mixed.
placebo
infusion placebo (group B)once a day and continued for 14 days
ginsenoside-Rd 20mg
2 ginsenoside-Rd injections (10mg/1ml/each) were respectively diluted by 2 specific dilutions (10%, 9 ml trimethylene glycol) and then mixed
ginsenoside-Rd 20mg
infusion of ginsenoside-Rd 20mg (group C) once a day and continued for 14 days
Interventions
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ginsenoside-Rd 10 mg
infusion ginsenoside-Rd 10 mg (group A)once a day and continued for 14 days
placebo
infusion placebo (group B)once a day and continued for 14 days
ginsenoside-Rd 20mg
infusion of ginsenoside-Rd 20mg (group C) once a day and continued for 14 days
Eligibility Criteria
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Inclusion Criteria
* the first episode
* from onset to admission within 72 hours
* NIHSS scores:5\~22
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Xijing Hospital
OTHER
Responsible Party
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Xijing Hospital
Principal Investigators
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Gang Zhao, MD
Role: STUDY_DIRECTOR
the Department of Neurology , Xijing Hospital;
Xuedong Liu, MD
Role: STUDY_CHAIR
the Department of Neurology, Xijing Hospital;
Locations
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the Department of Neurology , Xijing Hospital
Xi'an, Shaanxi, China
Countries
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References
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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.
Other Identifiers
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xijing-001
Identifier Type: -
Identifier Source: org_study_id
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