NCT04813445

Analysing the Effects of Xingnaojing for Mild-to-severe Acute Ischemic Stroke

Analysing the Effects of Xingnaojing for Mild-to-severe Acute Ischemic Stroke(AXAIS): A Multicenter, Randomized, Open-label, Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Dongzhimen Hospital, Beijing · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this trial is to analyse the Effects of Xingnaojing for Mild-to-severe Acute Ischemic Stroke by Metabonomics, proteomics and clinical parameters.

Detailed description

Xingnaojing is widely used in China, but there is lack of sufficient and reasonable explanation of its intervention effects for acute ischemic stroke currently. The primary hypothesis of this trial is that , Compared with the blank control group, Xingnaojing will produce serial changes in plasma and urine metabolites and biomarkers at baseline (pre-dose), 8 days and 11days . The serial changes may be the potential support to explain the intervention effect of Xingnaojing. All participants will have a National Institutes of Health Stroke Scale(NIHSS)entry score of 4-25. Participants who have planned or already received the intravenous thrombolysis or endovascular treatment will be excluded. The primary outcome will be determined at 11 days.

Conditions

• Acute Stroke
• Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Xingnaojing injection	Xingnaojing injection (20 ml)+0.9% diluted sodium chloride injection 250ml, IV (in the vein), every 12 hours for 10 days.

Timeline

• Start date: 2021-05-28
• Primary completion: 2022-06-28
• Completion: 2022-09-28
• First posted: 2021-03-24
• Last updated: 2022-02-18

Locations

1 site across 1 country: China