Ginsenoside-Rd for Acute Ischemic Stroke

Ischemic Stroke Clinical Trial

Official title:

Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke: A Randomized, Double-blind, Placebo-controlled, Phase Ⅱ, Multicenter Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00591084
• Other study ID #: xijing-001
• Status: Completed
• Phase: Phase 2
• First received: December 27, 2007
• Last updated: August 30, 2010
• Start date: September 2005
• Est. completion date: September 2006

Study information

• Verified date: December 2007
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: September 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	the Department of Neurology , Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NIHSS scores		15±1 days	No
Secondary	NIHSS scores		8 days	No
Secondary	the Barthel index		8 days	No
Secondary	the Barthel index		15 days	No
Secondary	the modified Rankin scale		15 days	No
Secondary	the modified Rankin scale		90 days	No