Ginsenoside-Rd for Acute Ischemic Stroke

NCT00591084 | Completed Phase 2 DMC

• 1 other identifier: xijing-001
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ischemic Stroke

Keywords

randomized trial; ischemic stroke; Ginsenoside-Rd

Outcome Measures

Primary Outcomes (1)

• NIHSS scores

  15±1 days

Secondary Outcomes (5)

• NIHSS scores

  8 days

• the Barthel index

  8 days

• the Barthel index

  15 days

• the modified Rankin scale

  15 days

• the modified Rankin scale

  90 days

Study Arms (3)

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.

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.

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

Drug: ginsenoside-Rd 20mg

Interventions

ginsenoside-Rd 10 mg DRUG

infusion ginsenoside-Rd 10 mg (group A)once a day and continued for 14 days

ginsenoside-Rd 10mg

placebo DRUG

infusion placebo (group B)once a day and continued for 14 days

placebo

ginsenoside-Rd 20mg DRUG

infusion of ginsenoside-Rd 20mg (group C) once a day and continued for 14 days

ginsenoside-Rd 20mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

the Department of Neurology , Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

• 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.

  PMID: 19236467 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

ginsenoside Rd

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gang Zhao, MD

  the Department of Neurology , Xijing Hospital;

  STUDY DIRECTOR

• Xuedong Liu, MD

  the Department of Neurology, Xijing Hospital;

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 27, 2007
• First Posted: January 11, 2008
• Study Start: September 1, 2005
• Primary Completion: June 1, 2006
• Study Completion: September 1, 2006
• Last Updated: September 1, 2010

Record last verified: 2007-12

Locations

CN (1)