Ginsenoside-Rd for Acute Ischemic Stroke

Air Force Military Medical University of People's Liberation Army

Status and phase: Completed; Phase 2

Conditions: Ischemic Stroke

Treatments: Drug: placebo; Drug: ginsenoside-Rd 20mg; Drug: ginsenoside-Rd 10 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT00591084

xijing-001

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of ginsenoside-Rd for acute ischemic stroke.

Full 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.

Enrollment: 199 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• between 18 to 75 years
• the first episode
• from onset to admission within 72 hours
• NIHSS scores:5~22

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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199 participants in 3 patient groups, including a placebo group

ginsenoside-Rd 10mg

Experimental group

Description:

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.

Treatment:

Drug: ginsenoside-Rd 10 mg

placebo

Placebo Comparator group

Description:

2 specific dilutions (10%, 1ml trimethylene glycol) were respectively diluted by 2 specific dilutions (10%, 9 ml trimethylene glycol) and then mixed.

Treatment:

Drug: placebo

ginsenoside-Rd 20mg

Experimental group

Description:

2 ginsenoside-Rd injections (10mg/1ml/each) were respectively diluted by 2 specific dilutions (10%, 9 ml trimethylene glycol) and then mixed

Treatment:

Drug: ginsenoside-Rd 20mg