Effectiveness and Safety of Angongniuhuang Pill on Restoring Consciousness for Patients Who Have Suffered From a Stroke

Phase 2

• Conditions: Stroke; Acute Ischemic Stroke
• Interventions: Drug: Angongniuhuang Pill; Drug: placebo

• Registration Number: NCT00817609
• Lead Sponsor: Fudan University

Brief Summary

This study will determine if Angongniuhuang Pill (Composed of Niuhuang, Yujin, Xijiao, Huangqin, Huanglian, Xionghuang, Zhizi, Zhusha, Bingpian, Shexiang, and Zhenzhu) will have a better effect in restoring consciousness for patients who have suffered from an acute ischemic stroke. The study is designed to look at both consciousness level and overall recovery and recovery of motor function, for example muscle strength and coordination.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-01-05
• Study First Submitted QC: 2009-01-05
• Study First Posted: 2009-01-06
• Status Verified: 2009-09
• Last Update Submitted: 2010-05-26
• Last Update Posted: 2010-05-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Occurrence of an acute ischemic stroke (between 9 and 72 h after onset) with
• A score of not higher than 12 of Glasgow Coma Scale (GCS)
• Patient age of between 18 and 80 years.
• Patients or their representatives voluntarily take part in this study and signed the informed consent

Exclusion Criteria

• Transient Ischemic attack(TIA), cerebral hemorrhage, subarachnoid hemorrhage
• Ischemic stroke that needs rt-PA treatment
• Subjects who are unlikely to complete taking the investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition.
• Pregnant or breast-feeding.
• Proven disability by law, such as blindness, deafness, dumb, disturbance of intelligence, mental disorders, limb handicap.
• Liable to be allergic (allergic to at lease 2 foods/drugs previously exposed)
• Had been participated in other clinical trials during the last 1 month prior to study inclusion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Angongniuhuang Pill	-
B	placebo	-

Primary Outcome Measures

Name	Time	Method
Glasgow Coma Scale (GCS) within 90 days after stroke onset.	90 days

Secondary Outcome Measures

Name	Time	Method
The percentage of patients of different consciousness level stratified according to the GCS, and the time spent of patients who recovered from coma.	90 days
Global disability on modified Rankin scale at 90 days.	90 days
NIH stroke scale	90 days
Changes in laboratory indexes as safety assessment, including red blood cell(RBC), white blood cell(WBC), platelet(PLT), alanine transarninase(ALT), aspartate transarninase (AST), blood urea nitrogen (BUN), creatinine(Cr) in blood samples; protein, red b	14 days

Trial Locations

Locations (1)

Zhongshan Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China